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Real Time Myocardial Contrast Echocardiography and Dobutamine Stress Perfusion Magnetic Resonance Imaging (ECHOBIKE)
This study is enrolling participants by invitation only.
First Received: March 12, 2009   Last Updated: September 17, 2009   History of Changes
Sponsor: University of Nebraska
Information provided by: University of Nebraska
ClinicalTrials.gov Identifier: NCT00861848
  Purpose

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
  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.

Condition Phase
Kawasaki Disease
Heart Disease
Phase I

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

Resource links provided by NLM:


Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Biospecimen Description:

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

Detailed Description:

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
Study Population

adults ages 13-40 with congenital and acquired congenital heart disease.

Criteria

Inclusion Criteria:• Age between 13 years and 40 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 pacemakerr, AICD, etc.)
  • Pregnant or possibly pregnant (based on history/information obtained from the patient) or breast feeding
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00861848

Locations
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68196
Sponsors and Collaborators
University of Nebraska
Investigators
Principal Investigator: Shelby Kutty, MD UNMC
Principal Investigator: Thomas Porter, MD UNMC
  More Information

No publications provided

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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on January 04, 2010