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Completed

NCT Number: NCT03231371

Coronary Artery Vasculopathy in Pediatric Heart Transplant Patients

Heart transplantation is a life-sustaining therapy that allows patients with either congenital or acquired heart disease and severe cardiac dysfunction to survive. Over time, however, the transplanted heart can develop problems. One of the more common and troubling problems is the development of stenoses, or narrowings, within the coronary arteries. These narrowings, technically referred to as coronary artery vasculopathy (CAV for short), account for the single most common cause of death or need for repeat heart transplant in persons more than one year post-transplant. Traditionally, CAV has been diagnosed at cardiac catheterization using coronary angiography (where dye is directly injected into the coronary blood vessels and viewed using special x-ray equipment called fluoroscopy). There is no good treatment for CAV aside from treatment of symptoms and listing for repeat heart transplantation. The goal of this study is to test several newer methods of diagnosing CAV. The first is called coronary flow reserve (catheterization test). The second is called Endo-PAT (a finger probe test) and the third is called contrast-enhanced cardiac MRI (MRI test, only for patients 12 and older). The older method (coronary angiography) will still be used in all cases, in addition to the new tests The goal is, one day, to be able to diagnose patients with CAV earlier in the course, prior to a patient's development of abnormal angiograms. If this can be done, it is possible that better therapies will be able to be used to stop or even reverse the development of CAV, perhaps reducing, or at least delaying, the need for repeat heart transplantation.

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Key information

Age range

1 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of MIchigan-Congenital Heart Center

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients age 1 - 25 years who are status-post OHT (≤18 years at the time of transplantation) and undergoing routine post-transplant surveillance catheterization for endomyocardial biopsy and coronary angiography

Exclusion criteria

  • The presence of sick sinus syndrome or 2nd or 3rd degree atrioventricular block (without a functioning implanted pacemaker)
  • Hemodynamically significant valvular disease
  • Severe asthma or bronchospasm, known severe CAV
  • Pulmonary hypertension.
  • Patients taking digoxin
  • Verapamil and dipyridamole are also excluded given known interactions with adenosine.

Treatment and study plan

Adenosine

Drug

Administration of intravenous adenosine infusion over 3 minutes (0.14 ml/kg, 3mg/ml concentration, total dose).

Primary outcomes

  1. Coronary Flow Reserve (CFR)

    Time frame: Baseline testing (acute only), 3 minutes of adenosine infusion

    Ratio of peak to baseline coronary flow velocity (CFV)

Secondary outcomes

  1. Gadolinium Enhancement by Cardiac MRI

    Time frame: Baseline MRI only

    Categorical measure - yes or no; number of participants with gadolinium enhancement

Sponsors and collaborators

Lead sponsor

Bryan Goldstein

Other

Registry information

Official study title

Early Detection of Coronary Artery Vasculopathy in Pediatric Heart Transplant Patients: A Prospective Assessment Using Coronary Flow Reserve and Contrast-Enhanced Cardiac MRI

Acronym: CFR-OHT

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Jul 27, 2017
Registry last updated
Sep 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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