Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00083395
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2004-05-22
Brief Title:
Isoproterenol Challenge to Detect Arrhythmogenic Right Ventricular Cardiomyopathy
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Utility of Isoproterenol Challenge Test to Detect Disease in Patients With Incomplete Diagnostic Criteria for Arrhythmogenic Right Ventricular Cardiomyopathy
Status:
COMPLETED
Status Verified Date:
2005-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will examine the usefulness of a new test called an isoproterenol challenge in patients with arrhythmogenic right ventricular cardiomyopathy ARVC and family members who may have the disease but do not have clear-cut evidence of it ARVC is a rare condition that runs in families Heart muscle is replaced with fatty scar-like tissue especially in the right ventricle lower pumping chamber of the heart and can sometimes extend to the left ventricle the main pumping chamber The fat can interfere with the heartbeat producing abnormal heart rhythms such as ventricular tachycardia VT - a very fast heartbeat that can cause sudden death especially in young people Isoproterenol is a drug that increases heart rate and heart muscle contractions In isoproterenol challenge subjects are given increasing doses of the drug through a catheter see details below to try to produce an abnormal heart rhythm
ARVC is hard to diagnose with current tests This study will see if isoproterenol challenge provokes VT in patients with the disease and can confirm the diagnosis if it can detect the disease in family members better than currently available tests and if it provokes abnormal rhythms in healthy control subjects In addition the study will explore the genetics of ARVC and determine whether infection could contribute to its development
Patients with ARVC their family members and normal volunteers 18 years of age and older may be eligible for this study Candidates are screened with a medical history and physical examination electrocardiogram EKG treadmill and bicycle exercise testing and an echocardiogram ultrasound test of the heart
Participants undergo the following tests and procedures
Blood tests - Blood is collected to study the genetics of ARVC to test for evidence of old infections and to measure brain natriuretic peptide - a hormone that can increase with development of heart failure
Heart magnetic resonance imaging MRI This test looks at heart structure and function MRI uses a magnetic field and radio waves to produce images of body tissues and organs The subject lies on a table that is moved into the scanner a narrow cylinder wearing earplugs to muffle loud knocking sounds that occur during the scanning process At some time during the test the subject is given a contrast agent called gadolinium through a catheter thin flexible tube in a vein to improve the scan pictures The scan time varies from 30 to 90 minutes with most scans lasting 60 minutes Control subjects do not undergo MRI
Isoproterenol challenge Subjects are given increasing doses of isoproterenol through a catheter until the heart rate reaches 100 to 120 beats per minute for no more than 1 hour A special EKG records heart rhythm during the test and an echocardiogram records right and left ventricular function
QRST surface mapping EKG This special EKG done with 64 or 120 leads maps abnormalities of heart rhythm and cardiac conduction during the isoproterenol challenge These tests are like a regular EKG except that more leads are placed on the chest and on the back as well
Patients and family members who wish to have follow-up visits may return to the NIH Clinical Center once a year for 5 years for guidance about therapy based on clinical considerations and new information or investigations
ARVC is hard to diagnose with current tests This study will see if isoproterenol challenge provokes VT in patients with the disease and can confirm the diagnosis if it can detect the disease in family members better than currently available tests and if it provokes abnormal rhythms in healthy control subjects In addition the study will explore the genetics of ARVC and determine whether infection could contribute to its development
Patients with ARVC their family members and normal volunteers 18 years of age and older may be eligible for this study Candidates are screened with a medical history and physical examination electrocardiogram EKG treadmill and bicycle exercise testing and an echocardiogram ultrasound test of the heart
Participants undergo the following tests and procedures
Blood tests - Blood is collected to study the genetics of ARVC to test for evidence of old infections and to measure brain natriuretic peptide - a hormone that can increase with development of heart failure
Heart magnetic resonance imaging MRI This test looks at heart structure and function MRI uses a magnetic field and radio waves to produce images of body tissues and organs The subject lies on a table that is moved into the scanner a narrow cylinder wearing earplugs to muffle loud knocking sounds that occur during the scanning process At some time during the test the subject is given a contrast agent called gadolinium through a catheter thin flexible tube in a vein to improve the scan pictures The scan time varies from 30 to 90 minutes with most scans lasting 60 minutes Control subjects do not undergo MRI
Isoproterenol challenge Subjects are given increasing doses of isoproterenol through a catheter until the heart rate reaches 100 to 120 beats per minute for no more than 1 hour A special EKG records heart rhythm during the test and an echocardiogram records right and left ventricular function
QRST surface mapping EKG This special EKG done with 64 or 120 leads maps abnormalities of heart rhythm and cardiac conduction during the isoproterenol challenge These tests are like a regular EKG except that more leads are placed on the chest and on the back as well
Patients and family members who wish to have follow-up visits may return to the NIH Clinical Center once a year for 5 years for guidance about therapy based on clinical considerations and new information or investigations
Detailed Description:
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 04-CC-0194 | None | None | None |