(281) 713-2962
800 Rockmead Drive, Suite 155
Kingwood, TX 77339
[email protected]
Cardiovascular Multimodality Imaging Study
Status: Recruiting
Location: Montefiore Medical Center
Conditions: Montefiore Medical Center
City/State:
Bronx, New York
Contact Information:
Name: Christine Park, MD
Phone Number:
678-451-6247
Email: [email protected]
Brief Summary
Determining the etiology of cardiomyopathy is of high clinical importance for optimal treatment strategy and prediction of prognosis. There is increased risk for cardiovascular disease and higher propensity for cardiovascular related mortality among Black and non-Hispanic White patients. Recently, advanced cardiac imaging has become a vital tool in diagnosis and risk stratification of cardiovascular disease. Very limited data is available on the prevalence and characteristics of different cardiovascular diseases in Hispanic and African American minority groups, therefore, studying different racial and ethnic minority groups in the Bronx population is an exceptionally valuable source to determine the prevalence of cardiomyopathies among minority groups along with study survival in this population. This study aims to determine the etiology of cardiovascular disease in a diverse patient population by utilizing various cardiovascular imaging modalities, with a focus on cardiac magnetic resonance (CMR) imaging and to develop risk stratification models by applying advanced cardiovascular imaging markers.
Detailed Description
Significant Hispanic and African American populations live in the Bronx and belong to the Montefiore Health System. Based on literature data, African Americans and Hispanics have a higher incidence of morbidity and mortality for various cardiovascular diseases (CVD) compared to non-Hispanic Whites. More than 53 million Hispanics currently live in the United States, which is 17% of the total US population and is expected to constitute 30% of the total US population by 2050. The increased risk for CVD is also well documented in the African American minority group. Although limited data is available on the prevalence and characteristics of different cardiovascular diseases in these minority groups. During the last two decades, advanced cardiovascular imaging modalities such as cardiovascular magnetic resonance (CMR) imaging became trusted tools in the risk stratification of patients with ischemic and non-ischemic cardiomyopathies.
Cardiovascular magnetic resonance (CMR) imaging is the gold standard for quantifying chamber size and function. In addition to ejection fraction, CMR feature-tracking (CMR-FT) is a new postprocessing technique that allows the assessment of myocardial mechanics from routinely acquired cine images without specialized additional pulse sequences. Basic global longitudinal strain has been proved as a predictive marker in non-ischemic cardiomyopathy (NICM). CMR imaging can also provide tissue-specific information about the myocardium using specific techniques such as late gadolinium enhancement (LGE) or other quantitative parameters like T1 mapping, both native and with measurement of extracellular volume fraction. Based on this, CMR imaging is an optimal modality to differentiate ischemic cardiomyopathy (ICM) and non-ischemic myocardial disease and diagnose different forms of NICM.
NICM represents a heterogeneous group of patients with multiple underlying etiologies. The pathogenesis of NICM with ventricular dilatation and reduced cardiac function in the absence of flow-limiting coronary artery disease (CAD) can be genetic, inflammatory, toxic, or viral. However, in the vast majority of cases, the origin is unclear. NICM may be either primary e.g. Hypertrophic cardiomyopathy (HCM), Right ventricular Arrhythmogenic Cardiomyopathy (ARVC), or secondary to systemic diseases such as Cardiac amyloidosis (CA), Anderson-Fabry disease, Sarcoidosis, or even iatrogenic as Cancer therapy-related cardiac dysfunction (CTRCD). Determining the etiology of cardiomyopathy is of high clinical importance for optimal treatment strategy and prediction of prognosis.
Upon further review, the Einstein Institutional Review Board (IRB) has determined that this is an ongoing, retrospective registry. and that there is no prospective component.
Read moreCZI Rare As One: Co-designing an App and Wearable Based Compass for Rare Diseases
Status: Active, Recruiting
Location:
Conditions:
City/State:
New York, New York
Contact Information:
Name: Stephen Friend, MD, PhD
Phone Number:
0012154213073
Email: [email protected]
Name: Sarah Goodday, PhD
Email: [email protected]
Brief Summary
The CZI Rare As One study is a Chan Zuckerberg Initiative funded study that aims to co-design and pilot test unique symptom tracking and transmitting apps across 5 different sub-arms that includes individuals with Long COVID, Pancreatitis, Sarcoidosis, Vasolin-Containing Protein (VCP) disease and Primary Ciliary disease (PCD). This study aims to use multimodal digital health tools to enable patients to self-monitor their symptoms in passive and active ways.
Detailed Description
The CZI Rare As One Study is a pilot, beta testing that aims to recruit ~50 participants per disease group (LongCOVID, pancreatitis, sarcoidosis, VCP disease, and PCD) totalling 250 participants. Participants will be instructed to us a co-designed study app alongside specific wearable and smart devices as outlined below for 5 months.
LongCOVID: Oura ring, Empatica EmbracePlus wristband, Lumia ear device Pancreatitis: Oura ring, Empatica EmbracePlus wristband Sarcoidosis: Oura ring VCP Disease: Oura ring, MIR Smart One Spirometer, Apple Watch series 8 PCD: Oura ring, MIR Smart One Spirometer
Research staff (engagement specialists) will check-in via phone every 2 weeks with participants to provide support, troubleshoot tech problems, solicit study-related feedback and collect context related information about the participants disease.
The study app collects symptom specific information for each disease group, measures of disease burden, quality of life, and information about participants routines through self-reported surveys and tasks (cognitive, active tasks) and passive phone metadata derived from SensorKit’s Research framework and an Android equivalent framework.
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An Open-Label Pilot Study of VTX2735 in Recurrent Pericarditis
Status: Recruiting
Location:
Conditions:
City/State:
Tucson, Arizona
St. Augustine, Florida
Chicago, Illinois
Park Ridge, Illinois
Owensboro, Kentucky
Houston, Texas
Contact Information:
Name: Ventyx Clinical Trial Contact
Phone Number:
888-411-5176 ext ext 108
Email: [email protected]
Brief Summary
This is a study to understand if taking VTX2735 is safe and effective in participants diagnosed with Recurrent Pericarditis (RP). Approximately 30 patients will take VTX2735.
The study consists of a 30-day Screening Period (to see if a participant qualifies for the study), a 6-week Open Label Treatment period (a participant receives active Dose A), a 7-week Extension Treatment period (a participant meets criteria for continuing and receives active Dose A) and a 14-day Follow-Up Period.
Read moreGlobal Cardio Oncology Registry (G-COR)
Status: Recruiting
Location: Cleveland Clinic- Florida
Conditions: Cleveland Clinic- Florida
City/State:
Weston, Florida
Contact Information:
Name: Diego Sadler, MD FACC
Phone Number:
5613898833
Email: [email protected]
Name: Rohit Moudgil, MD PhD
Phone Number:
216-445-1932
Email: [email protected]
Brief Summary
G-COR is the first Global Prospective Cardio-Oncology Registry. It is a multinational, multicenter prospective observational cohort registry, with the goal of collecting clinical, laboratory, imaging, demographic, and socioeconomic data to identify risk factors associated with increased incidence of cancer therapy related cardiovascular toxicity (CTR-CVT) in different settings and to derive and validate risk scores for cardio oncology patients treated in different geographic locations throughout the world.
Detailed Description
G-COR is the first Global Prospective Cardio-Oncology Registry. It is a multinational, multicenter prospective observational cohort registry, with the goal of collecting clinical, laboratory, imaging, demographic, and socioeconomic data to identify risk factors associated with increased incidence of cancer therapy related cardiovascular toxicity (CTR-CVT) in different settings and to derive and validate risk scores for cardio oncology patients treated in different geographic locations throughout the world.
G-COR will involve the collaboration from 124 hospitals from 24 countries that completed survey with sites demographics. It will evaluate cardiovascular disease in three distinct populations of cancer patients (hematological malignancies: lymphomas, leukemias, multiple myeloma; breast cancer patients; and patients treated with check point inhibitors immunotherapy).
G-COR will evaluate the cardiovascular impact of different cancer treatments in the above-described patients, and similarities and differences in diagnostic and treatment modalities as well as outcomes and the impact of socioeconomic factors and risk factors for toxicities in a large worldwide population.
G-COR will study the impact of cancer in CV disease in cancer patients treated at academic centers as well as in patients treated at community hospitals, through a systematic prospective data collection in a global digital platform.
G-COR is an IRB approved prospective registry, conducted with the logistical support of C5 Clinical Research Division and the Cardiovascular Outcomes Registries and Research (CORR) group at the Cleveland Clinic and have developed eCRFs with an extensive Red Cap Cloud platform.
G-COR Executive, Scientific and topic committees are led by North American, European, Latin American, Australian and Asian representatives from both academic and community centers.
The pilot phase of G-COR enrolls breast cancer patients only, and the global phase will include all three cohorts of patients (breast, Hem and ICIs).
The investigators have started enrolling patients for G-COR pilot phase with US centers, and will start the global international phase in 2023.
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Vitamin D Homeostasis in Sarcoidosis
Status: Recruiting
Location: University of Texas Southwestern
Conditions: University of Texas Southwestern
City/State:
Dallas, Texas
Contact Information:
Name: Connie Hsia, MD
Phone Number: 2146483426
Email: [email protected]
Name: Khashayar Sakhaee, MD
Phone Number: 2146480324
Email: [email protected]
Brief Summary
This study evaluates the relationship between vitamin-D status and severity of sarcoidosis, and the effects of vitamin-D repletion in vitamin-D insufficient patients with sarcoidosis. Half the patients with sarcoidosis who are vitamin-D insufficient will receive standard vitamin-D supplementation via standard regimen while the other half will receive a placebo. Sarcoidosis patients who are vitamin-D sufficient will also act as controls.
Detailed Description
Sarcoidosis is a multi-system inflammatory disease characterized by T-helper lymphocyte hyperactivity leading to granulomatous inflammation. The granuloma cells autonomously convert 25-hydroxy-vitamin-D (25OHD) to the active metabolite 1,25-dihydroxy-vitamin-D (1,25OH2D) independent of normal feedback control but dependent on substrate (25OHD) concentration.
Circulating 1,25OH2D exerts both anti-inflammatory and mineral metabolic actions. Deficiency of 25OHD limits substrate-dependent 1,25OH2D synthesis, diminishes anti-antigenic innate immunity and augments pro-inflammatory adaptive immunity. Thus, low vitamin-D stores could aggravate sarcoid inflammation while repletion of vitamin-D stores could mitigate inflammation in sarcoidosis.
Diagnostic Utility of SGLT1/2 Inhibition to Facilitate Myocardial Glucose Suppression
Status: Recruiting
Location: University of Pennsylvania
Conditions: University of Pennsylvania
City/State:
Philadelphia, Pennsylvania
Contact Information:
Name: Mary E Hansbury, BS
Phone Number: 2157468192
Email: [email protected]
Name: Erin Schubert, BA
Phone Number: 215-573-6569
Email: [email protected]
Brief Summary: This is a pilot mechanistic study of the diagnostic utility of sodium-glucose cotransporter-1/2 inhibition (SGLT1/2) on myocardial glucose suppression on FDG PET/CT. The investigators will test whether the addition of a SGLT1/2 inhibitor (SGLT1/2i) plus the standard dietary modification (ketogenic diet) will provide enhanced myocardial glucose suppression. The primary objective is to assess rates of complete myocardial glucose suppression (MGS) with 7 days of sotagliflozin 400 mg QD among healthy volunteers on a background of 1 day (N=20) or 3 days (N=20) of the KD. The secondary goal is to investigate the relationship between sotagliflozin, targeted metabolite levels, and myocardial glucose utilization on FDG-PET.
Participants will be asked to:
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- undergo a screening visit that includes blood tests, vitals, and questions regarding health history/medications
- take the provided sotagliflozin as instructed for 7 days leading up to the scan
- follow a ketogenic diet as instructed for 1 or 3 days leading up to the scan
- undergo an FDG PET/CT scan, which includes vitals and blood draws
Detailed Description The purpose of this mechanistic pilot study is to evaluate the effect on myocardial glucose suppression, and therefore on image quality, with the addition of a brief course of an FDA approved SGLT1/2 inhibitor prior to FDG PET/CT scan. FDG PET/CT is a clinically utilized scan for diagnosis of cardiac sarcoidosis following the standard diet and fasting requirements, this study will test the addition of the 7 days of sotagliflozin prior to the scan.
Sotagliflozin (INPEFA™) is a sodium-glucose cotransporter-2 inhibitor (SGLT1/2i) Sodium-glucose cotransporter-2 inhibitor that has been studied in humans and is FDA approved for reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with heart failure or type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors. In this study, the investigators will be using it “off-label” in healthy volunteers and will be using only a short course (approximately 1 week) of the drug prior to the FDG PET/CT PET scan. “Off-label” use is when an FDA approved drug is prescribed for a condition/use other than that for which the drug has been officially approved. Therefore, the study will be utilizing sotagliflozin in way that it has yet to be approved for by the FDA.
The investigators may enroll up to 40 fully evaluable healthy volunteers. A fully evaluable subject must complete the PET/CT scan. Subjects who do not complete the PET/CT scan will not be counted as fully evaluable, however, collected data may still be used in some secondary analyses. The participants will be aged at least 18 years old. After completing a screening visit and meeting study eligibility, each participant will undergo an FDG PET scan after taking sotagliflozin for 7 (up to 10 maximum) days and following a ketogenic diet for either 1 day (N=20) prior to the scan with overnight fasting or 3 days (N=20) prior to the scan with overnight fasting. Enrollment of the 20 participants undergoing 3 days of KD is dependent on sufficient funding, and therefore initial efforts will be targeted toward enrolling participants in the 1 day of KD stratum. Participants will be asked to track when they have taken the sotagliflozin in a provided diary.
FDG PET/CT imaging will be used to evaluate glycolytic activity in the heart using the FDA approved clinical Positron Emission Tomography (PET) radiotracer, [18F] Fluorodeoxyglucose (FDG) Imaging will be done on a dedicated whole-body PET scanner. For each PET scan, dynamic images over the body will be acquired from the time of injection to up to 60 minutes after injection of FDG. Imaging data will be processed as per standard protocols. The study will be performed under the regulatory approval of the Penn Institutional Review Board (IRB).
Participants will undergo an FDG PET/CT after taking 7 (up to 10 maximum) days of oral sotagliflozin overlapping with 1 or 3 day(s) of dietary modification (standard ketogenic diet) and overnight fasting prior to FDG injection.
For all subjects, the investigators may measure blood levels of BHB, lipids, basic metabolic panel, complete blood counts HbA1c, free fatty acid, acylcarnitine, glucose, and insulin at screening, some of these tests will be repeated on the day of the scan. The investigators plan to use the Penn Metabolomics Core and Penn Diabetes Radioimmunoassay and Biomarkers Core for sample processing. Since intravenous access will be obtained for administration of the tracer on the day of the PET scan, a blood draw will be performed from this line. Thereafter, the investigators will perform comprehensive, targeted metabolomic profiling from this peripheral blood so the study team can correlate myocardial suppression with other metabolic markers. Most of the research testing will occur at later dates with stored samples. The lab test results that may be entered in the medical record include BHB, lipids, basic metabolic panel, complete blood counts and glucose. Other experimental test results will not be provided to the subjects.
Participants will be asked to follow a standard prescribed ketogenic diet and keep a diet diary during the KD prior to the FDG PET visit, this diet matches the clinical SOC pre-scan preparation for sarcoidosis. On the day of FDG-PET, the diet diary will be collected and reviewed by an investigator. The diet will also be reviewed, usually at a later date, by a CHPS nutritional specialist and information reported by the subject will be used to perform meal analysis and estimate grams of fat, protein and carbohydrates.
This is a single institution, pilot mechanistic study of FDG PET/CT to determine optimal method of myocardial glucose suppression. Patients may participate in this study if they are greater than 18 years of age. Subjects that may meet eligibility criteria will be approached about study participation regardless of race or ethnic background.
CardiolRx in Recurrent Pericarditis Following IL-1 Blocker Cessation (MAVERIC)
Status: Recruiting
Location: Cleveland Clinic, Columbia University Medical Center, Massachusetts General Hospital, Mayo Clinic in Rochester, Northwestern University Medicine, University of Vermont Medical Center, University of Virginia
Conditions: Cleveland Clinic, Columbia University Medical Center, Massachusetts General Hospital, Mayo Clinic in Rochester, Northwestern University Medicine, University of Vermont Medical Center, University of Virginia
City/State:
Chicago, Illinois
Boston, Massachusetts
Rochester, Minnesota
Cleveland, Ohio
Charlottesville, Virginia
New York, New York
Burlington, Vermont
Contact Information:
Name: Andrea B Parker, MSc., PhD
Phone Number: +1 289 910 0862
Email: [email protected]
Name: Heather Dalgleish, MSc.
Phone Number:+1 289 910 0384
Email: [email protected]
Brief Summary: Multi-center, randomized, double-blind, placebo-controlled, phase-3 Trial. Patients with a history of recurrent pericarditis who are being treated with an IL-1 blocker for at least 12 months, scheduled to be discontinued, will be approached for potential trial participation.
Double-blind treatment will be initiated 10 – 14 days prior to the last scheduled dose of the IL-1 blocker and continued for 24 weeks.
The objective is to assess whether patients who discontinue therapy with an IL-1 blocker for recurrent pericarditis remain free of pericarditis recurrence while receiving CardiolRx.
Detailed Description: Double-blind, randomised, placebo-controlled Phase-3 trial. The primary objective is to assess whether patients with IL-1 blocker-dependent recurrent pericarditis can discontinue IL-1 blocker therapy and remain free of recurrence while receiving CardiolRx.
After informed consent is obtained, patients will be screened for eligibility. Baseline assessments will be performed during screening within 7 days of Day 1 (Visit 1) and include the following: Physical examination, vital signs, highest NRS pain score within the past 7 days of Day 1, 12-lead ECG; hematology (CBC with differential) and blood chemistry (including complete metabolic panel: sodium, potassium, calcium, glucose, ALT/AST, bilirubin, alkaline phosphatase, blood urea nitrogen (BUN), creatinine/eGFR), C-SSRS and a pregnancy test for women of childbearing potential.
Eligible patients will be randomized on Day 1 to either CardiolRx or matching placebo. Double-blind trial therapy will be initiated in the evening of Day 1, 10 – 14 days prior to the last scheduled dose of the IL-1 blocker and after all baseline assessments are completed. Trial therapy will be administered for 24 weeks.
Final efficacy assessments will take place 24 weeks after starting trial therapy and include a physical exam, vital signs, pain score NRS, a 12-lead ECG, as well as laboratory assessments (including a pregnancy test in women of childbearing potential) and a C-SSRS.
A safety follow-up visit will be scheduled 4 weeks after the last trial therapy administration.
Rilonacept in Subjects with Cardiac Sarcoidosis
Status: Recruiting
Location: Johns Hopkins University, Mayo Clinic in Rochester
Conditions: Johns Hopkins University, Mayo Clinic in Rochester
City/State:
Baltimore, Maryland
Rochester, Minnesota
Contact Information:
Lezlie Peterson, R.N.
Phone Number: 507-255-2029
Email: [email protected]
Brief Summary: The primary objective of this study is to evaluate the effect of rilonacept, added to standard therapy and compared with standard therapy alone, on improvement in myocardial inflammation in subjects with cardiac sarcoidosis after 24 weeks of therapy.
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FDG-PET As an Imaging Modality to Diagnose and Risk Stratify Subclinical, Imaging Negative Ici-Myocarditis
Status: Recruiting
Location: Mayo Clinic in Rochester
Conditions: Mayo Clinic in Rochester
City/State:
Rochester, Minnesota
Contact Information:
Clinical Trials Referral Office
Phone Number:
855-776-0015
Email: [email protected]
Brief Summary: The purpose of this pilot study is to evaluate Fluorodeoxyglucose – Positron Emission Tomography (FDG-PET) as an imaging modality to diagnose and risk stratify subclinical, imaging negative ICI-myocarditis, and to determine whether subclinical ICI-induced myocarditis is a distinct and clinically relevant entity with a risk of progression to fulminant myocarditis.
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A Study to Learn About The COVID-19 (Study) Vaccine (Called COMIRNATY) in People That Are Less Than 21 Years Old.
Status: Recruiting
Location: Boston Children's Hospital, Children's Healthcare of Atlanta - Egleston, Children's Hospital & Clinics of Minn, Children's Hospital - New Orleans, Children's Hospital Los Angeles, Children's Hospital of Colorado, Children's Hospital of Michigan, Children's Hospital of Philadelphia, Children's Mercy - Kansas City, Children's Minnesota, Children's National Hospital- Washington D.C., Children's of Alabama - Birmingham, Cincinnati Children's Hospital Medical Center, Columbia University Medical Center, Connecticut Children's Medical Center, Duke University Medical Center, FL, Indiana University, Indiana University School of Medicine, Lucile Packard Children's Hospital Stanford, Lurie Children's Hospital, Medical University of South Carolina (Musc) - Childrens Hospital, Nemours Children's Hospital Delaware, Northwell Health- Cohen Children's Medical Center, Phoenix Children's Hospital, Portland, Primary Children's - Salt Lake City, Seattle Children's Hospital, Seattle Children's Hospital & Research Institute, Texas Children's Hospital, The Hospital for Sick Children Toronto, UPMC Children's Hospital of Pittsburgh, University of Michigan Hospital-Mott Children's Hospital, Valley Children's Hospital, Washington University School of Medicine
Conditions: Boston Children's Hospital, Children's Healthcare of Atlanta - Egleston, Children's Hospital & Clinics of Minn, Children's Hospital - New Orleans, Children's Hospital Los Angeles, Children's Hospital of Colorado, Children's Hospital of Michigan, Children's Hospital of Philadelphia, Children's Mercy - Kansas City, Children's Minnesota, Children's National Hospital- Washington D.C., Children's of Alabama - Birmingham, Cincinnati Children's Hospital Medical Center, Columbia University Medical Center, Connecticut Children's Medical Center, Duke University Medical Center, FL, Indiana University, Indiana University School of Medicine, Lucile Packard Children's Hospital Stanford, Lurie Children's Hospital, Medical University of South Carolina (Musc) - Childrens Hospital, Nemours Children's Hospital Delaware, Northwell Health- Cohen Children's Medical Center, Phoenix Children's Hospital, Portland, Primary Children's - Salt Lake City, Seattle Children's Hospital, Seattle Children's Hospital & Research Institute, Texas Children's Hospital, The Hospital for Sick Children Toronto, UPMC Children's Hospital of Pittsburgh, University of Michigan Hospital-Mott Children's Hospital, Valley Children's Hospital, Washington University School of Medicine
City/State:
Birmingham, Alabama
Phoenix, Arizona
Los Angeles, California
Madera, California
Palo Alto, California
Aurora, Colorado
Harford, Connecticut
Wilmington, Delaware
Washington, DC
Hollywood, Florida
Atlanta, Georgia
Chicago, Illinois
Indianapolis, Indiana
New Orleans, Louisiana
Boston, Massachusetts
Ann Arbor, Michigan
Detroit, Michigan
Minneapolis, Minnesota
Kansas City, Missouri
Saint Louis, Missouri
New Hyde Park, New York
New York, New York
Durham, North Carolina
Cincinatti, Ohio
Portland, Oregon
Philadelphia, Pennsylvania
Pittsburgh, Pennsylvania
Charleston, South Carolina
Houston, Texas
Salt Lake City, Utah
Seattle, Washington
Toronto, Ontario
Contact Information:
Pfizer CT.gov Call Center
(800) 718-1021
email: [email protected]
Brief Summary
The purpose of this clinical trial is to learn about the safety and effects of the study vaccine (called COMIRNATY) for the potential prevention of COVID-19. This study is seeking participants who:
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- Are age <21 years.
- Have presentation to participating medical center with evaluation in Emergency Room and/or hospitalization.
- Received either the 1st, 2nd, 3rd or booster dose(s) of COMIRNATY within 7 days of symptom onset.
- Meet criteria of Centers for Disease Control and Prevention case definition of probable or confirmed myocarditis/pericarditis
- Are capable of giving signed informed consent/assent (by parents/legal guardians of minors and/or patients), which includes compliance with the requirements and restrictions listed in the Informed Consent/Assent Document and in this protocol OR meets criteria for waiver of consent.
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This study will examine the potential long-term effects associated with myocarditis/pericarditis following vaccination with COMIRNATY. The association of myocarditis/pericarditis in participants who received the study vaccine (COMIRNATY) compared with those associated with COVID-19 will also be examined. This will help us determine if COMIRNATY is safe and effective, and if there is a myocarditis/pericarditis association that should be noted. Participants will take part in this study for up to 5 years. During this time, they will receive complete cardiac imaging tests, and have follow up visits per guidance stated in the study protocol.
Detailed Description:
This is a low-interventional cohort study to determine cardiac and non-cardiac long-term outcomes of persons <21 years of age with myocarditis/pericarditis after the administration of COMIRNATY, compared with similarly aged persons with myocarditis/pericarditis associated with COVID-19, including MIS-C.
To be classified as having COMIRNATY-associated myocarditis/pericarditis, a person must 1) meet the CDC case definition for probable or confirmed myocarditis/pericarditis, 2) have received any dose of COMIRNATY ≤ 7 days of symptom onset, and 3) have no other plausible alternative etiology at the time of enrollment.
To be classified as having myocarditis/pericarditis associated with COVID-19, a person must have 1) either acute severe COVID-19 infection or MIS-C, as defined by the CDC, 2) findings of probable or confirmed myocarditis in the CDC definition, 3) no other plausible alternative etiology. A description of the three cohorts is as follows:
Cohort 1: Prospectively ascertained cases of probable or confirmed myocarditis/pericarditis associated with COMIRNATY , i.e., participants enrolled under protocol during hospitalization or </= 2 weeks of hospital discharge.
Cohort 2: Retrospectively ascertained cases of probable or confirmed myocarditis/pericarditis associated with COMIRNATY , i.e., participants enrolled > 2 weeks after hospital discharge. Participants can be retrospectively ascertained and enrolled at any time from their COMIRNATY-associated myocarditis/pericarditis.
Cohort 3: Comparator cohort of COVID-19- related myocarditis/pericarditis , including MIS-C, both retrospectively and prospectively ascertained, and enrolled at any time from their COVID-19 or MIS-C associated myocarditis/pericarditis diagnosis.
Participants in all cohorts will be those who present to participating medical centers for care. This study is a collaboration between the National Heart, Lung, and Blood Institute (NHLBI)’s Pediatric Heart Network (PHN) and Pfizer.
Enrollment will include approximately 300 prospectively and retrospectively ascertained cases of children, adolescents, and young adults <21 years of age who receive care for myocarditis/pericarditis associated with COMIRNATY (Cohort 1 and 2); and approximately 100 persons <21 years of age with COVID -19-associated myocarditis/pericarditis, including MIS-C (Cohort 3).
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