Coronary Artery Study in Pediatric Heart Transplantation (CAS-POHT)

This study has been withdrawn prior to enrollment.
(never approved by IRB)
Sponsor:
Collaborator:
University of Arkansas
Information provided by (Responsible Party):
Arkansas Children's Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT01546870
First received: March 3, 2012
Last updated: June 16, 2016
Last verified: June 2016
  Purpose
Transplant coronary artery disease (TCAD) is a significant cause of morbidity and mortality in pediatric heart transplantation (PHT). Understanding the pathophysiology and early detection along with attempted medical management are crucial in preventing advancement of the disease and retransplantation or mortality. Coronary angiogram, although routinely used is insensitive to detect early TCAD. Measurement of fractional flow reserve (FFR), coronary flow reserve (CFR) and index of microvascular resistance (IMR) using a doppler pressure and flow intracoronary wire may be more sensitive in evaluating the integrity of coronary vasculature and thus detect pre clinical TCAD. To the best of the investigators knowledge, measurement of these parameters has not been previously reported in PHT.

Condition
Transplant Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Arkansas Children's Hospital Research Institute:

Primary Outcome Measures:
  • Clinical coronary artery disease [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: April 2012
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
pediatric heart transplant recipients

  Eligibility

Ages Eligible for Study:   7 Years to 21 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pediatric heart transplant recipients
Criteria

Inclusion Criteria:

  • less than 21 years and above 7 years of age

Exclusion Criteria:

  • clinically significant coronary artery disease on angiography and inability to undergo IVUS
  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: NCT01546870

Locations
United States, Arkansas
Arkansas Children's hospital
Little Rock, Arkansas, United States, 72223
Sponsors and Collaborators
Arkansas Children's Hospital Research Institute
University of Arkansas
  More Information

Publications:
Responsible Party: Arkansas Children's Hospital Research Institute
ClinicalTrials.gov Identifier: NCT01546870     History of Changes
Other Study ID Numbers: ArkansasChRI 
Study First Received: March 3, 2012
Last Updated: June 16, 2016
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on July 28, 2016