- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01639937
Myocardial Perfusion and Scarring in Congenital Heart Disease
Quantitative Myocardial Perfusion, Myocardial Scarring and Their Contribution to Late Clinical Decompensation in Adults With Congenital Heart Disease
Background:
- People with congenital heart disease may develop heart failure earlier that those who do not have the disease. One theory to explain this is that the heart s own blood supply may be different in people with congenital heart disease. Problems with this blood supply can severely damage the heart. This damage can be studied with a heart imaging test called a cardiac magnetic resonance imaging (MRI) scan. Researchers want to use this type of scan to look at the blood supply to the heart in people with congenital heart disease.
Objectives:
- To learn more about the blood supply to the heart in people with congenital heart disease.
Eligibility:
- Individuals at least 18 years of age who have heart defects caused by congenital heart disease.
Design:
- Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected.
- Participants will have a cardiac MRI scan to look at the blood flow to the heart.
- Participants will also have a heart stress test to measure heart function during exercise.
- Other imaging studies of the heart may be performed to collect more information on heart function.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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District of Columbia
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Washington, District of Columbia, United States, 20010
- Childrens National Medical Center
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Maryland
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Bethesda, Maryland, United States, 20892
- National Institutes of Health Clinical Center, 9000 Rockville Pike
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Bethesda, Maryland, United States, 20814
- Suburban Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
- INCLUSION CRITERIA:
Inclusion Criteria for All Arms of the Protocol:
- Subjects 18 years of age or older
- All defects that have a right ventricle that supports the systemic circulation
- All defects with a functional single ventricle
- Written informed consent
EXCLUSION CRITERIA:
Exclusion Criteria for All Arms of the Protocol:
Subjects with a contraindication to MRI scanning will be excluded. These contraindications include subjects with the following devices:
- Central nervous system aneurysm clips
- Implanted neural stimulator
- Implanted cardiac pacemaker or defibrillator
- Cochlear implant
- Ocular foreign body (e.g. metal shavings)
- Implanted Insulin pump
- Metal shrapnel or bullet
- Severe heart damage that makes it difficult to breathe while lying flat
- Pregnant women (Women of childbearing potential who are uncertain as to whether they are pregnant will be required to have a screening urine or blood pregnancy test)
- Subjects with active symptoms of myocardial ischemia occurring despite maximally tolerated doses of oral antianginal therapy and intravenous nitroglycerin
Furthermore, the following subject groups will be excluded from studies involving the administration of MRI contrast agents:
- lactating women unless they are willing to discard breast milk for 24 hours after receiving gadolinium
- renal disease (estimated glomerular filtration rate [eGFR] < 30 ml/min/1.73 m2 body surface area)
The eGFR will be used to estimate renal function if reported by the laboratory. Otherwise, estimated glomerular filtration rate (eGFR) can be based on the Modification of Diet in Renal Disease (MDRD) study equation (see below) in subjects with stable renal function. This formula is not applicable to subjects with acute renal insufficiency:
eGFR (ml/min/1.73 m2) = 175 x (serum creatinine)-1.154 x (age)-0.203 x 0.742 (if the subject is female) x 1.212 (if the subject is black)
Additional Exclusion Criteria for Vasodilator Stress MRI:
- Myocardial infarction within 24 hours
- Uncontrolled heart failure
- Uncontrolled asthma or emphysema
- Ventricular arrhythmia (sustained ventricular arrhythmia at the time of MR scan)
- Second degree heart block or higher
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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1
Subjects with palliated congenital heart disease including, but not limited to, d TGA, ccTGA, single ventricles, hypoplastic left heart syndrome and tricuspid atresia will be recruited
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hypothesize that myocardial ischemia, as detectable by quantitative stress perfusion MRI, will predict systolic and diastolic dysfunction in subjects with single ventricle physiology and systemic right ventricles.
Time Frame: 5 years
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The specific aim of this study is to understand whether clinical subendocardial perfusion defects contribute to the late decompensation of adult subjects that have single ventricle physiology and adult subjects that have a systemic right ventricle.
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5 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
A portion of ventricular systolic or diastolic dysfunction will be predictable based on myocardial fibrosis or scarring related to the underlying pathophysiology of single ventricle physiology & systemic right ventricles or post-surgical...
Time Frame: 5 years
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A portion of ventricular systolic or diastolic dysfunction will be predictable based on myocardial fibrosis or scarring related to the underlying pathophysiology of single ventricle physiology & systemic right ventricles or post-surgical consequences.
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5 years
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myocardial scarring/fibrosis will correlate with symptoms, NYHA functional class and BNP.
Time Frame: 5 years
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myocardial scarring/fibrosis will correlate with symptoms, NYHA functional class and BNP.
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5 years
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Collaborators and Investigators
Investigators
- Principal Investigator: Arlene Sirajuddin, M.D., National Heart, Lung, and Blood Institute (NHLBI)
Publications and helpful links
General Publications
- Verheugt CL, Uiterwaal CS, van der Velde ET, Meijboom FJ, Pieper PG, van Dijk AP, Vliegen HW, Grobbee DE, Mulder BJ. Mortality in adult congenital heart disease. Eur Heart J. 2010 May;31(10):1220-9. doi: 10.1093/eurheartj/ehq032. Epub 2010 Mar 5.
- Rutledge JM, Nihill MR, Fraser CD, Smith OE, McMahon CJ, Bezold LI. Outcome of 121 patients with congenitally corrected transposition of the great arteries. Pediatr Cardiol. 2002 Mar-Apr;23(2):137-45. doi: 10.1007/s00246-001-0037-8. Epub 2002 Feb 19.
- Meijboom F, Szatmari A, Deckers JW, Utens EM, Roelandt JR, Bos E, Hess J. Long-term follow-up (10 to 17 years) after Mustard repair for transposition of the great arteries. J Thorac Cardiovasc Surg. 1996 Jun;111(6):1158-68. doi: 10.1016/s0022-5223(96)70217-9.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 120158
- 12-H-0158
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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