Myocardial Perfusion and Scarring in Adults With Congenital Heart Disease

Cardiac Disease Clinical Trial

Official title:

Quantitative Myocardial Perfusion, Myocardial Scarring and Their Contribution to Late Clinical Decompensation in Adults With Congenital Heart Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02861365
• Other study ID #: Pro00003067
• Secondary ID: contract
• Status: Completed
• Start date: July 2013
• Est. completion date: January 18, 2020

Study information

• Verified date: March 2021
• Source: Children's National Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a study of the perfusion of the myocardium in adults with specific forms of repaired congenital heart disease using established cardiac MRI techniques and correlating perfusion with clinical outcomes.

Description:

This is a study of the perfusion of the myocardium in adults with specific forms of repaired congenital heart disease using established cardiac MRI techniques and correlating perfusion with clinical outcomes. The investigators objectives are to examine myocardial perfusion both during stress and at rest in adults with repaired or palliated congenital heart disease as well as quantify ventricular function, regional myocardial strain and evidence of myocardial fibrosis with quantitative measures of myocardial perfusion. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: January 18, 2020
• Est. primary completion date: January 18, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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:

• Subjects with a contraindication to magnetic resonance imaging (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

Related Conditions & MeSH terms

• Cardiac Disease
• Heart Diseases

Locations

Country	Name	City	State
United States	Children's National Health System	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Children's National Research Institute	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. Epub 2002 Feb 19. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Myocardial Ischemia measuring coronary perfusion reserve.	Compare quantitative myocardial perfusion at stress and rest with measures of systolic and diastolic function in exams performed in close temporal proximity.	5 years
Primary	Myocardial Ischemia measuring ejection fraction.	Compare the extent of myocardial ischemia through ejection fraction measurement of the systemic ventricle.	5 years
Primary	Myocardial Ischemia measuring heart inflow Doppler.	Compare heart inflow Doppler of the systemic atrioventricular valve to understand the extent of myocardial ischemia.	5 years
Secondary	Scarring and fibrosis by measuring Late Gadolinium Enhancement results.	Directly compare the extent of myocardial scarring/fibrosis with echo-derived measures of systolic and diastolic function.	5 years
Secondary	Scarring and fibrosis by measuring systolic and diastolic function.	Compare the extent of myocardial scarring/fibrosis with echo-derived measures of systolic and diastolic function.	5 years
Secondary	Comparison of MRI measurements with blood test.	Number of participants with predictable future heart failure symptom will be assessed by comparing all cardiac MRI exam measurements with blood test.	5 years
Secondary	Comparison of MRI measurements with walk test.	Number of participants with predictable future heart failure symptom will be assessed by comparing all cardiac MRI exam measurements with walk test.	5 years
Secondary	Comparison of MRI measurements with NY Heart Association class	Number of participants with predictable future heart failure symptom will be assessed by comparing all cardiac MRI exam measurements with NY Heart Association class.	5 years