Trial record 10 of 10 for:    Vasculitis Syndromes of the Central and Peripheral Nervous Systems

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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
University of Nebraska
ClinicalTrials.gov Identifier:
NCT00861848
First received: March 12, 2009
Last updated: September 17, 2009
Last verified: September 2009
  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 1

Study Type: Observational
Study Design: Time Perspective: 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 ]

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by University of Nebraska

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Erin Sandene Clinical Research Coordinator, Pediatric Research Office
ClinicalTrials.gov Identifier: NCT00861848     History of Changes
Other Study ID Numbers: 599-08FB
Study First Received: March 12, 2009
Last Updated: September 17, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Mucocutaneous Lymph Node Syndrome
Vasculitis
Peripheral Nervous System Agents
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Lymphatic Diseases
Skin Diseases, Vascular
Skin Diseases
Dobutamine
Cardiotonic Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Sympathomimetics
Autonomic Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents

ClinicalTrials.gov processed this record on July 20, 2014