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Advanced Cardiac Imaging in Cardiac Allograft Vasculopathy

NCT01927614 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 5

Last updated 2024-08-21

No results posted yet for this study

Summary

Cardiac allograft vasculopathy (CAV) is a process of both immune and non-immune mediated thickening of the heart arteries of transplanted hearts. CAV limits the long term survival of heart transplant patients and is one of the common causes of death in the late post transplant period. Current methods of detecting CAV rest with invasive cardiac catheterization which carry repeated risks, as this test needs to be performed periodically through the life of a heart transplant patient. Traditional methods of coronary angiography identify CAV late in its course and is a crude method of evaluating coronary anatomy in heart transplant patients. Intravascular ultrasound is an additive tool that is able to detect early CAV before it becomes angiographically apparent, but still requires invasive cardiac catheterization to perform. However, it also limits assessment to the major epicardial arteries and does not give any information regarding the smaller branch vessels and cardiac microvasculature. Advances in cardiac CT and cardiac MRI hold potential to evaluate for CAV non-invasively. In addition, perfusion techniques may provide additional functional information regarding the status of the microvascular.

In this pilot study, we aim to demonstrate the feasibility of cardiac CT and cardiac MRI with and without perfusion protocols, in patients post-heart transplant and to describe and compare CT and MRI findings in patients with established CAV versus those with no CAV, as diagnosed by standard invasive methods.

Conditions

  • Heart Transplantation

Interventions

RADIATION

Cardiac CT

A 128-slice dual-source CT system will be used (Somatom Definition Flash, Siemens Healthcare, Germany). The CT scan protocol will comprise 3 steps. 1. Prospectively gated calcium scoring. 2. Stress-myocardial CT perfusion. 3. Rest Coronary CT angiography and myocardial CT perfusion. Automated computed tomography dose index (CTDIvol) and dose- length-product (DLP) will be collected from the scanner, and effective dose will be calculated using the DLP conversion factor (0.014) for each component of the cardiac CT protocol. Based on local dose audits the predicted dose range will be 3.5 mSv to 8 mSv depending on patient body habitus.

Sponsors & Collaborators

  • Nova Scotia Health Authority

    lead OTHER

Principal Investigators

  • Brian Clarke, MD · Staff Cardiologist and Clinical Assistant Professor, Division of Cardiology, QE II Health Science Centre, Dalhousie University and Capital District Health Authority

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-13
Primary Completion
2015-07-17
Completion
2015-07-17

Countries

  • Canada

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 NCT01927614 on ClinicalTrials.gov