Overview

This trial is active, not recruiting.

Condition cardiac disease
Sponsor Children's Research Institute
Collaborator National Heart, Lung, and Blood Institute (NHLBI)
Start date July 2013
End date December 2019
Trial size 20 participants
Trial identifier NCT02861365, CNMC 3067

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure
Myocardial Ischemia measuring coronary perfusion reserve.
time frame: 5 years
Myocardial Ischemia measuring ejection fraction.
time frame: 5 years
Myocardial Ischemia measuring heart inflow Doppler.
time frame: 5 years

Secondary Outcomes

Measure
Scarring and fibrosis by measuring Late Gadolinium Enhancement results.
time frame: 5 years
Scarring and fibrosis by measuring systolic and diastolic function.
time frame: 5 years
Number of participants with predictable future heart failure symptom will be assessed by comparing all cardiac MRI exam measurements with blood test.
time frame: 5 years
Number of participants with predictable future heart failure symptom will be assessed by comparing all cardiac MRI exam measurements with walk test.
time frame: 5 years
Number of participants with predictable future heart failure symptom will be assessed by comparing all cardiac MRI exam measurements with NY Heart Association class.
time frame: 5 years

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Quantitative Myocardial Perfusion, Myocardial Scarring and Their Contribution to Late Clinical Decompensation in Adults With Congenital Heart Disease
Principal investigator Laura Olivieri, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Children's Research Institute.