Coronary Artery Study in Pediatric Heart Transplantation

Transplant Coronary Artery Disease Clinical Trial

— CAS-POHT  

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01546870
• Other study ID #: ArkansasChRI
• Status: Withdrawn
• Phase: N/A
• First received: March 3, 2012
• Last updated: June 16, 2016
• Start date: April 2012
• Est. completion date: April 2012

Study information

• Verified date: June 2016
• Source: Arkansas Children's Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 21 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Transplant Coronary Artery Disease

Locations

Country	Name	City	State
United States	Arkansas Children's hospital	Little Rock	Arkansas

Sponsors (2)

Lead Sponsor	Collaborator
Arkansas Children's Hospital Research Institute	University of Arkansas

Country where clinical trial is conducted

United States, 

References & Publications (1)

Fearon WF, Hirohata A, Nakamura M, Luikart H, Lee DP, Vagelos RH, Hunt SA, Valantine HA, Fitzgerald PJ, Yock PG, Yeung AC. Discordant changes in epicardial and microvascular coronary physiology after cardiac transplantation: Physiologic Investigation for Transplant Arteriopathy II (PITA II) study. J Heart Lung Transplant. 2006 Jul;25(7):765-71. Epub 2006 May 24. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical coronary artery disease		1 year	No