Real Time Myocardial Contrast Echocardiography and Dobutamine Stress Perfusion Magnetic Resonance Imaging (ECHOBIKE)
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|ClinicalTrials.gov Identifier: NCT00861848|
Recruitment Status : Unknown
Verified September 2009 by University of Nebraska.
Recruitment status was: Enrolling by invitation
First Posted : March 16, 2009
Last Update Posted : September 21, 2009
The present study is designed to:
- 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
- compare RT-MCE with dobutamine stress perfusion MR for determination of coronary flow reserve and ventricular wall motion
- assess regional myocardial mechanics using myocardial speckle tracking and MR tagging.
|Condition or disease||Phase|
|Kawasaki Disease Heart Disease||Phase 1|
Individuals will be identified from the cardiology database and consented during their routine follow up visits. Exercise stress, transthoracic echocardiography and cardiac MR are part of standard medical care in the follow up evaluation of adolescents and adults with repaired congenital heart disease. The use of contrast (with transthoracic echocardiography) and dobutamine stress testing (with the cardiac MR) will be performed as part of the research study. After signing consent/ assent, a study subject will have pertinent medical history (e.g. past palliation and operative repair dates and type, current medications, review of systems) and physical exam findings extracted from the medical record, especially the recording of the most recent clinic visit. If the subject is a female of child bearing age, a serum pregnancy test will be done at this time. This data will be recorded using standardized case report forms for history and physical exam. The study patients will complete a standardized interview to determine their exercise tolerance according to New York Heart Association (NYHA) classification. All patients who consent to the additional testing will require an additional 1 hour of time to the regular Echo and CMR testing.
Each patient will have the protocol supine bicycle stress with contrast echocardiogram performed at UNMC Echo lab.. The study subject will then have the clinically indicated CMR study (Philips Achieva 1.5T magnet), scheduled and performed by a qualified CMR technologist, working with a pediatric or adult cardiologist. An attempt will be made to have CMR and Echo performed on the same day to minimize physiologic variability, but will at least be done within 1 week each other. Further post-processing (wall motion analyses, speckle tracking and myocardial tagging) and image analyses will be performed by the principal investigators on standard workstations.
|Study Type :||Observational|
|Estimated Enrollment :||80 participants|
|Official Title:||Quantification of Ventricular Mechanics and Myocardial Blood Flow Reserve in Adolescents and Adults Ages 13-40 With Congenital or Acquired Heart Disease Using Supine Bicycle Stress With Real Time Myocardial Contrast Echocardiography and Dobutamine Stress Perfusion Magnetic Resonance Imaging|
|Study Start Date :||April 2009|
|Estimated Primary Completion Date :||June 2010|
|Estimated Study Completion Date :||June 2011|
U.S. FDA Resources
|13-40 with heart disease|
- 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. [ Time Frame: 2 years ]
- 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. [ Time Frame: 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00861848
|United States, Nebraska|
|University of Nebraska Medical Center|
|Omaha, Nebraska, United States, 68196|
|Principal Investigator:||Shelby Kutty, MD||UNMC|
|Principal Investigator:||Thomas Porter, MD||UNMC|