Coronary Artery Study in Pediatric Heart Transplantation

Withdrawn

• Conditions: Transplant Coronary Artery Disease

• Registration Number: NCT01546870
• Lead Sponsor: Arkansas Children's Hospital Research Institute

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-03-03
• Study First Submitted QC: 2012-03-06
• Study First Posted: 2012-03-07
• Study Start: 2012-04
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-16
• Last Update Posted: 2016-06-20

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical coronary artery disease	1 year

Trial Locations

Locations (1)

Arkansas Children's hospital; 🇺🇸 Little Rock, Arkansas, United States