CompletedNot Applicable

Real Time Myocardial Contrast Echocardiography and Dobutamine Stress Perfusion Magnetic Resonance Imaging

United States124 participantsStarted 2009-04-01

Plain-language summary

The present study is designed to: 1. investigate the safety and efficacy of Real time myocardial echocardiography (RT-MCE) in adolescents and adults ages 12-50 with congenital and acquired congenital heart disease 2. compare RT-MCE with dobutamine stress perfusion MR for determination of coronary flow reserve and ventricular wall motion 3. assess regional myocardial mechanics using myocardial speckle tracking and MR tagging. 4. evaluate RV volume and function for a subset of subjects using novel reconstruction software

Who can participate

Age range

12 Years – 50 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:• Age between 12 years and 50 years. * Male or female. * History of repaired congenital heart disease including atrial septal defects, aortic valve disease, tetralogy of fallot, transposition of great arteries and anomalous left coronary artery from pulmonary artery. * History of sequelae of heart disease acquired as an infant or child, including Kawasaki disease and coronary ectasia, and patients post anthracycline chemotherapy. * Ability to perform Supine bicycle stress with contrast echocardiography as determined by primary cardiologist and/or Dr. Shelby Kutty. * Ability to perform CMR with dobutamine stress as determined by the patients primary cardiologist and/or Dr. Shelby Kutty * Signed informed consent and assent as applicable. Exclusion Criteria:• Atrial or ventricular arrythmias that cannot be controlled to heart rates \< 70/min * Intracardiac shunts * Known hypersensitivity to perflutren * Known hypersensitivity to Dobutamine * Congestive heart failure in NYHA class II, III or IV * Claustrophobia or any other reason patient is unable to perform CMR (i.e. ferromagnetic implants causing significant artifact that alters image quality, presence of pacemaker, AICD, etc.) * Pregnant or possibly pregnant (based on history/information obtained from the patient) or breast feeding

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

The present study is designed to: (1) investigate the safety and efficacy of Real time myocardial echocardiography (RT-MCE) in adolescents and adults ages 13-40 with congenital and acquired congenital heart disease.

Timeframe: 2 years

Trial details

NCT IDNCT00861848

SponsorUniversity of Nebraska

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2019-02-01

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