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| Sponsor: | University of Nebraska |
|---|---|
| Information provided by: | University of Nebraska |
| ClinicalTrials.gov Identifier: | NCT00861848 |
Purpose
The present study is designed to:
| Study Type: | Observational |
| Study Design: | Prospective |
| 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 |
| Estimated Enrollment: | 80 |
| Study Start Date: | April 2009 |
| Estimated Study Completion Date: | June 2011 |
| Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| 13-40 with heart disease |
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.
Eligibility| Ages Eligible for Study: | 13 Years to 40 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
adults ages 13-40 with congenital and acquired congenital heart disease.
Inclusion Criteria:• Age between 13 years and 40 years.
Exclusion Criteria:• Atrial or ventricular arrythmias that cannot be controlled to heart rates < 70/min
Contacts and Locations| 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 |
More Information
| Responsible Party: | Pediatric Research Office ( Erin Sandene Clinical Research Coordinator ) |
| Study ID Numbers: | 599-08FB |
| Study First Received: | March 12, 2009 |
| Last Updated: | September 17, 2009 |
| ClinicalTrials.gov Identifier: | NCT00861848 History of Changes |
| Health Authority: | United States: Institutional Review Board |
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Mucocutaneous Lymph Node Syndrome Neurotransmitter Agents Skin Diseases, Vascular Heart Diseases Vasculitis Molecular Mechanisms of Pharmacological Action Adrenergic Agents Adrenergic beta-Agonists Skin Diseases Sympathomimetics Cardiotonic Agents Physiological Effects of Drugs |
Vascular Diseases Cardiovascular Agents Protective Agents Adrenergic Agonists Dobutamine Pharmacologic Actions Lymphatic Diseases Autonomic Agents Therapeutic Uses Cardiovascular Diseases Peripheral Nervous System Agents |