TerminatedNot Applicable

Myocardial Perfusion and Scarring in Congenital Heart Disease

Stopped: PI is leaving NHLBI, sample size is too small.

United States18 participantsStarted 2012-10-24

Plain-language summary

Background: \- 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.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

* INCLUSION CRITERIA: Inclusion Criteria for All Arms of the Protocol: * 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: Exclusion Criteria for All Arms of the Protocol: * Subjects with a contraindication to 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 fu…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Hypothesize that myocardial ischemia, as detectable by quantitative stress perfusion MRI, will predict systolic and diastolic dysfunction in subjects with single ventricle physiology and systemic right ventricles.

Timeframe: 5 years

Trial details

NCT IDNCT01639937

SponsorNational Heart, Lung, and Blood Institute (NHLBI)

Sponsor typeNIH

Study typeOBSERVATIONAL

Primary completion2017-04-01

View on ClinicalTrials.gov More Congenital Heart Disease trials