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Scanner and Transplant Heart Patients Protocol

NCT01122810 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2011-03-09

No results posted yet for this study

Summary

Coronary vasculopathy remains the leading cause of decreased survival after the first year post-transplantation. It is mainly asymptomatic because of the denervation of the heart transplant. Currently, annual invasive coronary angiogram is performed to ensure the lack of coronary narrowing. But invasive coronary angiography caries risks of serious adverse events and some concern rise from its repetition in that population. Recent advance in coronary multidetector computed tomography (CT) may allow non invasive visualization of the coronary tree. But, it remains unknown if the encouraging data observed in native coronary artery analysis can be extrapolated to transplant heart recipients. Indeed, only very small sample size studies (20 patients) have been conducted in this particular setting. Thus, the investigators decide to assess the diagnostic accuracy of the 64-row CT and 256-row CT compared to the gold standard coronary angiogram in a larger sample size study. The practice aim of this study is to determine if the conventional invasive coronarography can be switched by the 64-row CT or the 256-row CT to assess coronary anatomy especially for the patient without any coronary artery disease (CAD) or those with CAD not suitable for percutaneous coronary intervention.

Conditions

  • Heart Transplant Patients

Interventions

PROCEDURE

Coronary scanner

The ECG-gated contrast-enhanced multidetector computed tomography coronary angiography will be performed with a 64 or 256-row CT Philips, Brilliance. The contrast medium mean quantity used is 80-100 ml. The CT scan parameters, adapted to the patient's weight, include 120 kV, 800mA, 0.625 mm slice thickness, 0.42-s rotation time and 0.2 pitch. To determine X-Ray exposure, Dose Length Product (Gycm) will be measured. Reconstruction will be performed at 40 and 75 % of the cycle using ECG gating. A semi quantitative analyse of coronary narrowing will be performed blindly to coronary angiogram results by two experienced radiologists. The CT quality will be determined using a quality scale from 1 to 5. A Calcification score will also be determined. A segment analyse will be performed according to AHA classification. Only more than 1.5 mm diameter vessel segments will be analysed.

Sponsors & Collaborators

  • French Federation of Cardiology

    collaborator OTHER

  • French Cardiology Society

    lead OTHER

Principal Investigators

  • Olivier Barthelemy, MD · Pitié-Salpêtrière Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2010-11-30
Completion
2010-11-30

Countries

  • France

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 NCT01122810 on ClinicalTrials.gov