Utility of Isoproterenol Challenge Test to Detect Disease in Patients With Incomplete Diagnostic Criteria for Arrhythmogenic Right Ventricular Cardiomyopathy
Data Collection
Congenital Abnormalities+4
+ Cardiovascular Diseases
+ Heart Defects, Congenital
Summary
Study start date: May 1, 2004
Actual date on which the first participant was enrolled.Arrhythmogenic right ventricular cardiomyopathy (ARVC) formerly referred to as arrhythmogenic right ventricular dysplasia (ARVD) is a familial hetergenous clinical and molecular disease characterized by dilatation and dysfunction of the right ventricle and ventricular arrhythmias. The ventricular arrhythmias are heart rate and catecholamine dependent. Not infrequently, there is involvement of the left ventricle. The diagnosis of ARVC is critical as therapy including implantable defibrillators may prevent sudden death. However, identification of affected family members remains a major challenge due to limitation of current imaging and diagnostic techniques. We propose (1) to establish the sensitivity and specificity of the isoproterenol challenge test for ARVC by testing both patients with known ARVC and healthy volunteers; (2) to estimate the proportion of family members who present with incomplete criteria for ARVC but are subsequently diagnosed with the condition by an isoproterenol challenge test; and, (3) to study the inheritance of ARVC and the potential role of occult infection in its development.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.160 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
INCLUSION CRITERIA: Patients with ARVC: Either gender, aged greater than 5 years. The presence of two major criteria; one major and two minor criteria; or four minor criteria from separate diagnostic categories. Normal Volunteers: Age and gender matched with ARVC patients, age greater than 18 years. No known cardiac disease. Normal EKG, normal echocardiogram, normal Bruce protocol treadmill exercise test. Family Members of Patients with ARVC: Either gender, aged greater than 5 years. A proband with ARVC EXCLUSION CRITERIA: Patients with ARVC: Pregnancy or lactation excludes tests with potential risk, e.g. radiation, isoprenaline, MRI, but does not exclude 12-lead ECG and echocardiogram. Coronary artery disease. Known infiltrate or congenital heart disease that could mimic the appearances of ARVC. Asthma prevents participation in Isoproterenol infusion. Any other condition that would prevent participation in the study. Normal Volunteers: Pregnancy or lactation. Asthma. Coronary artery disease, hypertension, diabetes, hypertrophic cardiomyopathy, or other known cardiomyopathy. Known infiltrative or congenital heart disease that could mimic the appearances of ARVC. Any Acute or chronic illness. Chronic drug therapy. Family Members of Patients with ARVC: Pregnancy or lactation excludes tests with potential risk, e.g. radiation, isoprenaline, MRI, but does not exclude 12-lead ECG and echocardiogram. Coronary artery disease. Known infiltrative or congenital heart disease that could mimic the appearances of ARVC. Asthma prevents participation in Isoproterenol infusion. Any other condition that would prevent participation in the study.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location