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Endothelial Injury and Development of Coronary Intimal Thickening After Heart Transplantation

NCT01848301 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2017-09-06

No results posted yet for this study

Summary

Coronary allograft vasculopathy (CAV) is the leading cause of late graft failure and second leading cause of late mortality after heart transplantation. CAV has been associated with a variety of traditional risk factors for atherosclerosis; however, immune mediated injury from development of de-novo donor-specific antibodies after transplantation also likely plays an important role. Similar to the progression of traditional atherosclerosis, it is likely that endothelial dysfunction is the precursor to the development of intimal thickening and CAV.

The investigators hypothesize that coronary allograft vasculopathy after heart transplantation as defined by progressive neointimal hyperplasia is preceded by endothelial dysfunction, which in turn is at least partly mediated by donor specific antibodies.

The investigators are proposing a prospective study in humans to test the above hypothesis and further mechanistically understand how CAV progresses. In this study the investigators will test for coronary endothelial function by infusing acetylcholine into the coronary artery and measure intimal hyperplasia by optical coherence tomography (OCT) and compare findings in patients with and without donor specific antibodies.

Conditions

  • Cardiac Allograft Vasculopathy
  • Antibody Mediated Rejection

Interventions

DEVICE

Optical Coherence Tomography

OCT imaging of the LAD coronary artery

DRUG

Acetylcholine

Infusion in the coronary artery to study endothelial function

PROCEDURE

Brachial Artery Flow Mediated Dilation

Assess peripheral brachial artery endothelial function

Sponsors & Collaborators

  • Gladwin, Mark, MD

    lead INDIV

Principal Investigators

  • Catalin Toma, MD · University of Pittsburgh

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2014-09-30
Completion
2017-05-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01848301 on ClinicalTrials.gov