Myocardial Perfusion and Scarring in Congenital Heart Disease
NCT ID: NCT01639937
Last Updated: 2021-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
18 participants
OBSERVATIONAL
2012-10-24
2019-12-12
Brief Summary
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\- 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.
Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* All defects that have a right ventricle that supports the systemic circulation
* All defects with a functional single ventricle
* Written informed consent
Exclusion Criteria
* 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)
* 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
18 Years
80 Years
ALL
No
Sponsors
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Children's National Research Institute
OTHER
Suburban Hospital
OTHER
National Heart, Lung, and Blood Institute (NHLBI)
NIH
Responsible Party
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Principal Investigators
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Arlene Sirajuddin, M.D.
Role: PRINCIPAL_INVESTIGATOR
National Heart, Lung, and Blood Institute (NHLBI)
Locations
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Childrens National Medical Center
Washington D.C., District of Columbia, United States
Suburban Hospital
Bethesda, Maryland, United States
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
Countries
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References
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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.
Related Links
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NIH Clinical Center Detailed Web Page
Other Identifiers
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12-H-0158
Identifier Type: -
Identifier Source: secondary_id
120158
Identifier Type: -
Identifier Source: org_study_id