Myocardial Perfusion and Scarring in Adults With Congenital Heart Disease

NCT02861365 | Completed

• 2 other identifiers: Pro00003067contract
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiac Disease

Outcome Measures

Primary Outcomes (3)

• 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

• Myocardial Ischemia measuring ejection fraction.

  Compare the extent of myocardial ischemia through ejection fraction measurement of the systemic ventricle.

  5 years

• 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 Outcomes (5)

• Scarring and fibrosis by measuring Late Gadolinium Enhancement results.

  5 years

• Scarring and fibrosis by measuring systolic and diastolic function.

  5 years

• Comparison of MRI measurements with blood test.

  5 years

• Comparison of MRI measurements with walk test.

  5 years

• Comparison of MRI measurements with NY Heart Association class

  5 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary care clinic

You may qualify if:

• 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

You may not qualify if:

• 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:

Sponsors & Collaborators

• Children's National Research Institute: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Children's National Health System

Washington D.C., District of Columbia, 20010, United States

Location

Related Publications (3)

• 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.

  PMID: 20207625 BACKGROUND

• 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.

  PMID: 11889523 BACKGROUND

• 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.

  PMID: 8642816 BACKGROUND

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

• Laura Olivieri, MD

  Children's National Health Systems

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 12, 2016
• First Posted: August 10, 2016
• Study Start: July 1, 2013
• Primary Completion: January 18, 2020
• Study Completion: January 18, 2020
• Last Updated: March 5, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: MRI report becomes available once the scan has been assessed, usually within 24 hours. It will be available indefinitely.
• Access Criteria: Primary care takers will have access to this report.

Locations

US (1)