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Stress Cardiac MRI for Evaluation of Nonspecific Allograft Dysfunction

NCT02597543 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2017-08-22

Study results available
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Summary

The investigators will use cardiac MRI to measure the myocardial perfusion reserve and amount of myocardial edema and fibrosis in heart-transplant patients with nonspecific allograft dysfunction in contrast to those with normal graft function. The investigators hypothesize that patients with nonspecific allograft dysfunction will demonstrate decreased myocardial perfusion reserve, related to microvascular allograft vasculopathy, compared to those with normal graft function.

Conditions

  • Heart Transplant
  • Acute Graft Rejection
  • Chronic Graft Rejection

Interventions

DRUG

Regadenoson

For use in stress myocardial perfusion imaging.

DRUG

Gadolinium

For use in both perfusion imaging and late gadolinium enhancement.

PROCEDURE

Cardiac MRI

Cardiac MRI will be the imaging modality for perfusion imaging, late gadolinium enhancement and obtaining mean T1 segmental values of the heart.

Sponsors & Collaborators

  • Astellas Pharma Inc

    collaborator INDUSTRY

  • Paul Kim

    lead OTHER

Principal Investigators

  • Paul J Kim, MD · Stanford University

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2016-06-30
Completion
2016-06-30

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 NCT02597543 on ClinicalTrials.gov