Skip to main content
Clinical Trials/NCT02861365
NCT02861365
Completed
N/A

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

Children's National Research Institute1 site in 1 country18 target enrollmentJuly 2013
ConditionsCardiac Disease

Overview

Phase
N/A
Intervention
Not specified
Conditions
Cardiac Disease
Sponsor
Children's National Research Institute
Enrollment
18
Locations
1
Primary Endpoint
Myocardial Ischemia measuring coronary perfusion reserve.
Status
Completed
Last Updated
5 years ago

Overview

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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
July 2013
End Date
January 18, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Children's National Research Institute
Responsible Party
Principal Investigator
Principal Investigator

Laura Olivieri

MD

Children's National Research Institute

Eligibility Criteria

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)

Outcomes

Primary Outcomes

Myocardial Ischemia measuring coronary perfusion reserve.

Time Frame: 5 years

Compare quantitative myocardial perfusion at stress and rest with measures of systolic and diastolic function in exams performed in close temporal proximity.

Myocardial Ischemia measuring ejection fraction.

Time Frame: 5 years

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

Myocardial Ischemia measuring heart inflow Doppler.

Time Frame: 5 years

Compare heart inflow Doppler of the systemic atrioventricular valve to understand the extent of myocardial ischemia.

Secondary Outcomes

  • 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)

Study Sites (1)

Loading locations...

Similar Trials