Coronary Artery Study in Pediatric Heart Transplantation

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01546870

Acronym

CAS-POHT

Enrollment

Registered

2012-03-07

Start date

2012-04-30

Completion date

2012-04-30

Last updated

2016-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Transplant Coronary Artery Disease

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

7 Years to 21 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Clinical coronary artery disease	1 year

Countries

United States

Outcome results