Recruiting

Use of CXCL9 as a Biomarker of Acthar Efficacy (Acthar)

Status: Recruiting

Location: University of California- San Francisco

Conditions: University of California- San Francisco

City/State:

San Fransisco, California

Contact Information:

Laura Koth, MD
(415) 514-4369
[email protected]

Brief Summary:
The objective is this study is to test whether use of Acthar gel in the context of sarcoidosis will lead to improved symptoms and lung function and correlate with decreased levels of predictive blood biomarkers, like chemokine ligand 9 (CXCL9).
Detailed Description:
The investigators will test whether Acthar gel’s anti-inflammatory properties will modulate immune cells and lead to decreases in blood biomarkers and improvements in clinical parameters. Specific Aim 1 will examine the levels of the predictive biomarker, chemokine ligand 9 (CXCL9), and related transcripts, and determine whether they decrease in participants over time while taking Acthar. Specific Aim 2 will test whether the biologic changes measured in blood correlate to clinical markers, including lung function and symptom scores. Since the investigators have found that CXCL9 predicts clinical course, they hypothesize that CXCL9 transcript levels in the blood will decrease over time in pulmonary sarcoidosis participants whose clinical outcome measures improve with Acthar.
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Delayed-Enhancement Cardiovascular Magnetic Resonance in Patients With Sarcoidosis

Status: Recruiting

Location: Duke University Medical Center

Conditions: Duke University Medical Center

City/State:

Durham, North Carolina

Contact Information:

Han W Kim, MD
919-668-3539
[email protected]

Raymond J. Kim, MD
919-668-3539
[email protected]

Brief Summary:
The primary objective of this study was to determine the ability of cardiac magnetic resonance (CMR) to identify cardiac involvement in patients with sarcoidosis. Patients were to undergo CMR in addition to routine clinical evaluation.
Detailed Description:
In patients with sarcoidosis, cardiac death is a leading cause of mortality which may represent unrecognized cardiac involvement. Cardiovascular magnetic resonance (CMR) can detect cardiac involvement including minute amounts of myocardial damage. Therefore, the objective of this study was to determine the usefulness of CMR and compare it with standard clinical evaluation for cardiac involvement. Patients with documented extracardiac sarcoidosis or clinically suspected cardiac sarcoidosis will be enrolled.
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Worldwide Sarcoidosis Research Study (WISE)

Status: Recruiting

Location: University of Iowa

Conditions: University of Iowa

City/State:

Iowa City, Iowa

Contact Information:

Alicia K Gerke, MD
319-356-1869
[email protected]

Deborah Hunter
319-356-1869
[email protected]

Brief Summary:

The aim of this study is to collect information about the clinical course and characteristics of sarcoidosis patients around the world through web-based surveys. Recruitment is directed at and driven by patients in the sarcoidosis community. This will allow the the investigators to study sarcoidosis patients across all demographic, geographic, and socioeconomic boundaries, not just patients seen at large research centers. The investigators believe this study can give investigators a broader and less biased view of sarcoidosis. The investigators would also like to collect genetic samples on this population to assess genetic variance in different phenotypes.

The information for the study would be provided through a web based survey system that can be accessed by patients or physicians of patients from any computer with Internet access. This system would collect clinical information in sufficient detail so that the phenotype of individual patients can be evaluated. Upon agreeing to participate in further research studies through the website, subjects will also have the opportunity to provide a DNA sample.

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Epigenetic Regulation of Altered T-cell Immunity in Sarcoidosis

Status: Recruiting

Location: University of California- San Francisco

Conditions: University of California- San Francisco

City/State:

San Fransisco, California

Contact Information:

Victoria Wang, BS
415 476 9225
[email protected]

Brief Summary:
Sarcoidosis is a multi-system granulomatous disorder that is triggered and influenced by gene-environment interactions. Although sarcoidosis predominantly affects the lungs in most cases, the clinical disease course is highly variable and any organ can be affected leading to end organ damage despite currently available therapeutics that unfortunately also have numerous and potentially devastating side effects. The environmental triggers of sarcoidosis are unknown but several occupational, environmental and infectious agents have been associated with sarcoidosis in susceptible hosts. Exposure to these triggers result in inflammation, characterized by activation of CD4+ T-cells, cytokine production, subsequent recruitment of other immune cells, and granuloma formation. Although several genetic markers have been associated with sarcoidosis, none fully explain individual susceptibility or clinical course variability, strongly implicating the environment and epigenetics. We have the ability to generate a map of the epigenetic histone modifications in immune cells via Chromatin Immuno-Precipitation coupled with next generation sequencing (ChIP-seq) and a map of transcriptome profiles via RNA-seq. The availability of histone and transcriptional signatures defining T cell activity in sarcoidosis will help identify the specific molecular programs affected by disease processes and can become the basis for future discovery of novel biomarker diagnostics in a clinical setting.
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Janus Kinase Inhibition in Sarcoidosis

Status: Recruiting

Location:

Conditions:

City/State:

New Haven, Connecticut

Contact Information:

William Damsky, M.D.
203-785-4092
[email protected]

Yvette Strong
203-737-2506
[email protected]

Brief Summary:
The purpose of this study is to investigate the role of the oral JAK1 inhibitor, abrocitinib 200 mg once daily, for the treatment of patients with moderate to severe cutaneous sarcoidosis.
Detailed Description:
To determine if JAK1 specific inhibition is effective in treating sarcoidosis, an inflammatory condition that can cause disfiguring skin lesions. The only FDA approved therapy is prednisone, a nonspecific immunosuppressant. The primary outcome will be the percent change in the Cutaneous Sarcoidosis Activity and Morphology Instrument (CSAMI) after 6 months of abrocitinib 200 mg daily in 10 patients with moderate to severe cutaneous sarcoidosis.The primary objective of this study is to determine whether oral abrocitinib reduces the CSAMI (a cutaneous sarcoid clinical scoring tool) in patients with moderate to severe cutaneous sarcoidosis. The CSAMI tool was selected over other scoring metrics given the highest interrater reliability of this metric in cutaneous sarcoidosis and the ability to generate subscores for active disease versus scarring. Secondary outcomes will include percent changes in organ involvement on whole body PET-CT imaging, Patients reported outcomes 1) Sarcoidosis related quality-of-life (QoL) metric (King’s Sarcoidosis Questionnaire), 2) Skin related quality of life (Skindex-16) metric, 3) sarcoidosis Fatigue Assessment Scale (FAS), and 4) Rhinosinusitis Disability Index (RSDI). Secondary outcomes will also include evaluation of molecular signatures before and during treatment. Soluble IL-2 receptor levels in plasma are the most reliable known biomarker for sarcoidosis and will be assessed at 0 and 6 months. Additional secondary outcomes will include correlative immunologic changes in skin tissue and blood as a result of treatment. Documentation of any spontaneously reported adverse events will be completed throughout the study.
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Cardiac Sarcoidosis Randomized Trial

Status: Recruiting

Location: Montefiore Medical Center, Ohio State University Medical Center, Tufts Medical Center, University of Michigan, University of Minnesota, University of Utah, Virginia Commonwealth University, Yale-New Haven Hospital

Conditions: Montefiore Medical Center, Ohio State University Medical Center, Tufts Medical Center, University of Michigan, University of Minnesota, University of Utah, Virginia Commonwealth University, Yale-New Haven Hospital

City/State:

New Haven, Connecticut

Boston, Massachusetts

Ann Arbor, Michigan

New York, New York

Columbus, Ohio

Pittsburgh, Pennsylvania

Salt Lake City, Utah

Richmond, Virginia

Contact Information:

David H Birnie, MD
613-696-7269
[email protected]

Janine Ryan, BAH, CCRP
613-696-7000 ext 17077
[email protected]

Brief Summary:

Prospective randomized controlled trial comparing low dose Prednisone(or Prednisolone)/Methotrexate combination to standard dose Prednisone(or Prednisolone) in patients diagnosed with acute active clinically manifest cardiac sarcoidosis and not yet treated.

The Investigators hypothesize that low dose Prednisone(or Prednisolone)/Methotrexate combination will be as effective as standard dose Prednisone(or Prednisolone), and result in significantly better quality of life and less toxicity than standard dose Prednisone(or Prednisolone).

Detailed Description:

Subjects meeting the study inclusion/exclusion criteria will be randomized equally to receive either:

Everywhere but Japan:

  1. Prednisone 0.5 mg kg/day for 6-months (MAX dose 30 mg per day) or
  2. Methotrexate 15-20 mg po, sc, or IM once a week for 6-months + Folic Acid 2 mg OD for 6 months + Prednisone 20 mg day for 1 month, then 10 mg OD for 1 month, then 5 mg OD for one month then STOP
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REgiStry Of the NAtural History of recurreNt periCarditis in pEdiatric and Adult Patients

Status: Recruiting

Location: Alaska Heart & Vascular Institute, Barnes-Jewish Hospital/Washington University, Brigham and Women's Hospital, Carnegie Mellon University, Cincinnati Children's Hospital Medical Center, Cleveland Clinic, Houston Methodist Hospital, Johns Hopkins University, Legacy Hospital and Health Center DBA Legacy Research Institute, Mayo Clinic in Rochester, Midwest Cardiovascular Research Foundation, Minneapolis Heart Institute Foundation, NYU Langone Health, Northwell Health - Lenox Hill Hospital, Pima Heart and Vascular, Scripps Health, Seattle Children's Hospital, TKL Research Inc., University of California - San Diego, University of Nebraska Medical Center, University of Vermont Medical Center, Virginia Commonwealth University

Conditions: Alaska Heart & Vascular Institute, Barnes-Jewish Hospital/Washington University, Brigham and Women's Hospital, Carnegie Mellon University, Cincinnati Children's Hospital Medical Center, Cleveland Clinic, Houston Methodist Hospital, Johns Hopkins University, Legacy Hospital and Health Center DBA Legacy Research Institute, Mayo Clinic in Rochester, Midwest Cardiovascular Research Foundation, Minneapolis Heart Institute Foundation, NYU Langone Health, Northwell Health - Lenox Hill Hospital, Pima Heart and Vascular, Scripps Health, Seattle Children's Hospital, TKL Research Inc., University of California - San Diego, University of Nebraska Medical Center, University of Vermont Medical Center, Virginia Commonwealth University

City/State:

Anchorage, Alaska

Tucson, Arizona

La Jolla, California

San Diego

Davenport, Iowa

Baltimore, Maryland

Boston, Massachusetts

Minneapolis, Minnesota

Rochester, Minnesota

Saint Louis, Missouri

Omaha, Nebraska

Fair Lawn, New Jersey

New York, New York

Cincinnati, Ohio

Cleveland, Ohio

Portland, Oregon

Pittsburgh, Pennsylvania

Houston, Texas

Burlington, Vermont

Richmond, Virginia

Seattle, Washington

Contact Information:

JoAnn Clair, PhD
781 431 9100
[email protected]

Brief Summary:
The registry will focus on furthering the understanding of the natural history of recurrent pericarditis (RP), as well as document RP-related clinical, health-related quality of life (HRQoL), and economic burden and will assist the medical community to refine or develop data-driven recommendations for clinical management of RP patients to optimize clinical outcomes. It also aims to generate data in support of the impact of rilonacept on clinical outcomes in a real-world population.
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Impact of CardiolRxTM on Recurrent Pericarditis (MAvERIC-Pilot)

Status: Recruiting

Location: Cleveland Clinic, Massachusetts General Hospital, Mayo Clinic in Rochester, MedStar Heart and Vascular Institute, Minneapolis Heart Institute Foundation, Pima Heart and Vascular, University of Vermont Medical Center, Virginia Commonwealth University

Conditions: Cleveland Clinic, Massachusetts General Hospital, Mayo Clinic in Rochester, MedStar Heart and Vascular Institute, Minneapolis Heart Institute Foundation, Pima Heart and Vascular, University of Vermont Medical Center, Virginia Commonwealth University

City/State:

Tucson, Arizona

Washington D.C.

Minneapolis, Minnesota

Rochester, Minnesota

Cleveland, Ohio

Burlington, Vermont

Richmond, Virginia

Boston, Massachusetts

Contact Information:

Andrea B Parker, PhD
+1 289 910 0862
[email protected]

Andrew Hamer, MD
[email protected]

Brief Summary:
Patients with recurrent pericarditis who are refractory or intolerant to current therapeutic management options or who require long-term administration of corticosteroids to control their disease are particularly challenging to manage. The pathogenesis of pericarditis involves the activation of the inflammasome. CardiolRxTM is known to have anti-inflammatory properties, including modulation of inflammasome signaling. This pilot study is to assess the tolerance and safety of CardiolRxTM during the resolution of pericarditis symptoms, assess improvement in objective measures of disease, and during the extension period, assess the feasibility of weaning concomitant background therapy including corticosteroids while taking CardiolRxTM.
Detailed Description:

Multi-center, open label Pilot Study. Patients who present with recurrent pericarditis will be screened and informed consent obtained.

Baseline assessments include the following: Clinical assessment, including vital signs, highest NRS pain score within the past 7 days of Day 1, 12-lead ECG; C-SSRS as well as hematology and blood chemistry and a pregnancy test for women with child-bearing potential.

Concomitant medications are recorded and any (S)AEs after informed consent has been obtained.

Study treatment will be initiated in the evening of Day 1, after all baseline assessments are completed.

Oral administration is as follows:

  • Initial starting dose (Day 1 p.m. dose to Day 3 a.m. dose):5 mg/kg of body weight CardiolRxTM
  • Day 3 p.m. dose to Day 10 a.m. dose: 7.5 mg/kg of body weight CardiolRxTM b.i.d.
  • Day 10 p.m. dose to end of treatment period: 10.0 mg/kg of body weight CardiolRxTM b.i.d.

If the next higher dose after each study drug increase is not tolerated, the dose will be reduced to the previous tolerated dose.

Unless contraindicated in the opinion of the investigator, after 8 weeks of treatment, patients will enter an 18-week extension period (EP), in which they continue study treatment while their concomitant medications will be weaned.

Follow-up Procedures Every visit (before the next dose increase) the patient will be re-evaluated. This includes ECG monitoring at approximately 5 hours post-morning dose (Tmax) to surveil for deleterious effects on ECG intervals (particularly the QTc interval) and rhythm.

Drug titration will be dependent on investigator or designate interrogation of the ECGs and the absence of new, clinically significant abnormalities on those ECGs.

Vital signs, concurrent medication and (S)AEs will be recorded at all visits. Blood chemistry including liver function tests, hematology as well as INR assessments will be carried out at selected visits.

Final efficacy assessments will take place after 26 weeks of study treatment and include a clinical assessment, vital signs, pain score NRS, a 12-lead ECG, the C-SSRS, as well as laboratory assessments.

For patients who do not enter the EP, Final assessments will be done after 8 weeks.

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Myocardial Injury and Dysfunction Associated with COVID-19 Vaccination

Status: Recruiting

Location: University of Colorado Anschutz Medical Campus

Conditions: University of Colorado Anschutz Medical Campus

City/State:

Aurora, Colorado

Contact Information:

Rachel Rosenberg, MS 303-724-4544 [email protected]

Natasha Altman, MD 303-724-4544 [email protected]

Brief Summary:
The overall goal of the study is to investigate the characteristics and potential mechanisms responsible for myocardial injury and dysfunction in patients after COVID-19 vaccination. Cardiac damage will be assessed with cardiac MRI and endomyocardial biopsy (EmBx) histopathology. Myocardial gene expression will be measured in RNA extracted from EmBxs mRNA abundance compared to nonfailing and failing control hearts.
Detailed Description:

To determine whether there is microvascular thrombosis-associated myocardial damage and dysfunction vs. inflammation or other changes in patients who, following administration of SARS-CoV-2 mRNA vaccine, develop evidence of myocardial injury typically diagnosed as “myocarditis” based on cardiac MRI findings.

Further, the degree of inflammatory reaction vs. microthrombotic injury to cardiac myocytes from biopsied myocardial tissue will be compared with biopsied myocardial tissue from control hearts. mRNA expression of the ACE2 and ITGA5 binding targets of SARS-Cov-2 Spike protein encoded by mRNA vaccines, as well as expression of other genes that may contribute to post-vaccine pro-thrombotic and pro-inflammatory states including Coagulation Factor 3 (F3, also known as tissue factor), ACE, AGTR1 and AGT) or a dysfunctional cardiac state (NPPB as a marker of pathologic remodeling) will be examined as candidate genes. Additional, global gene expression is being measured by RNA-Seq and microarray.

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Mayo AVC Registry and Biobank

Status: Recruiting

Location: Mayo Clinic

Conditions: Mayo Clinic

City/State:

Rochester, Minnesota

Contact Information:

Nicholas Wozniak 507-255-8794 [email protected]

Anwar A Chahal, Ph.D. [email protected]

Brief Summary:

Arrhythmogenic ventricular cardiomyopathy (AVC) is a genetic condition which affects the heart and can lead to heart failure and rhythm problems, of which, sudden cardiac arrest or death is the most tragic and dangerous. Diagnosis and screening of blood-relatives is very difficult as the disease process can be subtle, but sufficient enough, so that the first event is sudden death.

The Mayo Clinic AVC Registry is a collaboration between Mayo Clinic, Rochester, USA and Papworth Hospital, Cambridge University Hospitals, Cambridge, UK. The investigators aim to enroll patients with a history of AVC or sudden cardiac death which may be due to AVC, from the US and UK. Family members who are blood-relatives will also be invited, including those who do not have the condition. Data collected include symptoms, ECG, echocardiographic, MRI, Holter, loop recorder, biopsies, exercise stress testing, blood, buccal and saliva samples.

Objectives of the study:

  1. Discover new genes or altered genes (variants) which cause AVC
  2. Identify biomarkers which predict (2a) disease onset, (2b) disease progression, (2c) and the likelihood of arrhythmia (ventricular, supra-ventricular and atrial fibrillation)
  3. Correlate genotype with phenotype in confirmed cases of AVC followed longitudinally using clinical, electrocardiographic and imaging data.
  4. Characterize desmosomal changes in buccal mucosal cells with genotype and validate with gold-standard endomyocardial biopsies
Detailed Description:

Sudden cardiac arrest (SCA) accounts for over 360,000 deaths in the US and 400,000 in Europe per annum, including thousands under the age of 40 who die unexpectedly and without warning. Whilst the majority of SCAs are triggered by heart attacks, in those under the age of 40 years this tends to be due to genetic heart disease, which if identified early may save lives of other family members. Epidemiological and post-mortem studies have shown arrhythmogenic ventricular cardiomyopathy (AVC) as a leading cause of SCA, responsible for up to 25% of deaths in this age group.

AVC is a highly clinically and genetically heterogeneous condition, which results in fibro-fatty replacement of myocardium which may lead to ventricular dysfunction, heart failure, electrical rhythm disturbances and SCD. Although AVC predominantly affects the right ventricle (ARVC), it can affect both the right and left ventricle, or the LV in isolation (ALVC) and result in a type of dilated cardiomyopathy (DCM) with a propensity for arrhythmia (aDCM). Recent reports of aDCM with a familial distribution suggests this is undiagnosed AVC, reflecting heterogeneity and limited understanding. AVC is considered a disease of the desmosome (cell-adhesion proteins) and this has led to identification of desmosomal mutations (plakoglobin, plakophilin-2, desmoplakin, desmoglein-2 and desmocollin), mostly inherited in an autosomal dominant manner with incomplete penetrance and variable expressivity. Non-desmosomal genes have also been discovered (desmin, titin, RYR2, transforming growth factor -3, transmembrane protein 43 and phospholamban). Together, these only account for 50-60% of known AVc-related mutations, with the remainder being genetically undetermined. Additionally, multiple mutations also exist within families and within individuals further compounding the complexity of AVC. Inter and intra-familial variability is inexplicable with current knowledge, and suggests epigenetic and environmental factors contributing to phenotype. Disease expression is highly variable even amongst members of the same family with the same mutation making clinical detection and cascade screening a challenge. Finally, predicting which patients are at risk of SCD who have AVC or may have AVC is difficult and potentially lethal. Since SCD can be the first lethal and tragic manifestation of the disease, optimizing screening strategies is of paramount importance. The long-term goals of this program are to leverage our well-phenotyped cohort of patients with AVC at Mayo Clinic and Papworth Hospital, University of Cambridge, , enroll others and to discover novel pathogenic variants, correlate genotype with phenotype, and develop robust screening tools for the diagnosis of AVC and preventing SCD.

Overall hypothesis: that the onset of AVC can be reliably and accurately predicted in first-degree relatives of index cases using genetic, electrocardiographic (ECG) and imaging data.

Aim #1: Identify novel candidate genes and variants associated with AVC (including cases involving the right, left and the dilated cardiomyopathy types). This aim will be accomplished using next generation sequencing of probands-family member trios “genomic familial triangulation” approach and an innovative bioinformatics, statistical, and systems based biology approach.

Aim #2: Correlate genotype with phenotype in confirmed cases of AVC followed longitudinally using clinical, ECG and imaging data to 2a. predict disease onset; 2b. predict disease progression; and 2c. predict the likelihood of arrhythmia (ventricular, supra-ventricular and atrial fibrillation).

Aim #3: Combine registries from the Mayo Clinic, Rochester, USA and Papworth Hospital, University of Cambridge, UK, to study longitudinal data and correlate genotype with phenotype.

Aim #4: Characterize desmosomal changes in buccal mucosal cells with genotype and validate with gold-standard endomyocardial biopsies.

Project approval:

This study is approved by the Mayo Clinic IRB and Papworth Hospital NHS Foundation Trust for collation of existing data to develop the registry.

New directions for the project will seek appropriate approval by the IRB of each site in due course.

Recruitment strategy:

Patients who are already seen at Mayo Clinic Rochester and Papworth Hospital sites will be enrolled, provided research authorization is active. A HIPPA waiver has been approved as the registry collates existing data. Standard Mayo Clinic policy is to inform patients that clinical data can be utilized for research purposes, and patients are asked to specifically decline research authorization if they wish to opt out. A similar system is in place at Papworth Hospital.

For specific aims which require blood or other bio-specimens for the biobank, a separate IRB will be utilized and this requires a signed consent form.

Baseline data includes but is not limited to the following, at index presentation or screening visit for first-degree relatives:

  • Baseline demographics
  • Clinical history
  • Examination findings including features suggestive of cardio-cutaneous syndromes etc.
  • Family history of at least 3 generations. An online tool will be utilized for generating a pedigree (http://www.progenygenetics.com/online-pedigree)
  • Serial ECG data (12-lead, signal-averaged and Brugada protocols)
  • Continuous ECG monitoring data (Holter, extended-Holter, event recorders, implantable loop recorders etc.)
  • Imaging data (echocardiography, cardiac MRI, cardiac CT)
  • Cardiopulmonary exercise testing or exercise stress testing
  • Questionnaires on exercise capacity, activities of daily living (these will be approved by the IRB if self-completed by patients)
  • Cardiac catheterization data
  • Existing genotyping data (including methods used)
  • Where available, endomyocardial biopsy data

For clinical follow-up visits and screening follow-up of first-degree relatives, in addition to those test above, the following will be collected:

  • Cardiac implantable electronic devices data
  • Cardiac electrophysiology studies, and where catheter ablation delivered, this will be recorded

Biobank for genotyping and novel variant discovery:

Current guidelines recommend genetic testing for index cases and blood-relatives. Where this is performed and available, this will be collected.

Probands and their blood-relatives will be invited to participate in this optional component of the study. Blood, saliva and buccal scrapings will be collected from probands and blood relatives, to identify current pathogenic variants associated with AVC, and to discover novel variants.

Biobank for novel biomarker discovery:

Blood will be stored at baseline and subsequent visits to test for known blood-biomarkers of disease progression (such as high-sensitivity cardiac troponins, natriuretic peptides, high-sensitivity CRP and cytokines). Blood will also be stored for high throughput ‘omics (transcriptomics, metabolomics and proteomics) to identify novel biomarkers which reflect disease progression, prognostication and crucially help illuminate new biological pathways.

Annual Clinical Assessment:

Most patients with AVC are followed-up annually or more frequently dependent upon symptoms. At each follow-up an ECG and/or Holter is usually performed. The investigators will ensure each site performs this consistently. Data generated will be used for the registry. In addition, investigators may contact patients by telephone to assess symptoms (following IRB approval).

Follow-up at every 3-year interval:

Clinical guidelines for screening first-degree relatives recommend follow-up approximately every 3 years, as phenotype expression can be delayed (with the exception of familial cases where a pathogenic variant has been identified, and the blood-relative is negative). Thus, this time period has been chosen for subsequent follow-up visits, where patients will be re-assessed by 2010 Task Force Criteria for evidence of AVC. This follow-up visit will include:

  • Clinical history
  • Examination
  • ECG (12-lead and signal-averaged)
  • Holter monitoring
  • Repeat cardiac MRI
  • Exercise testing (CPET or treadmill)

It is our objective to continue this registry indefinitely, in order to capture adequate event rates for valid and accurate modelling to predict disease progression.

Data Collation and Management:

The investigators will use the REDCap (Research Electronic Data Capture) tool for completion of case report forms at enrollment and follow-up visits (link to a demonstration website https://projectredcap.org). The servers are based in-house at Mayo Clinic, with access only provided to approved study personnel. No personal identifiable information will be collated online. All cases will have a unique study ID, with the key to link each subject ID to patient identifiable data located at each site, and only available to the PIs and senior research personnel.

The data stored is considered confidential and will not be disclosed to any 3rd parties, with the exception of the participants clinical health-care providers responsible for the patient’s welfare.

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