NCT01122810

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

March 2, 2010

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 13, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

March 9, 2011

Status Verified

March 1, 2011

Enrollment Period

2.4 years

First QC Date

March 2, 2010

Last Update Submit

March 8, 2011

Conditions

Heart Transplant Patients

Keywords

Diagnostic accuracy of coronary angiographyTransplant heart patientsX-Ray and contrast agent exposureCoronary stenosis

Outcome Measures

Primary Outcomes (1)

  • sensitivity of CT : Frequency of stenosis diagnosed by CT in comparison with frequency of stenosis diagnosed by coronarography

    Day 1

Secondary Outcomes (2)

  • specificity, positive predictive value, negative predictive value of CT

    Day 1

  • X-Ray and contrast agent exposure

    Day 1

Interventions

Coronary scannerPROCEDURE

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.

Also known as: 64 ou 256 row coronary computed tomography

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Transplant heart patients
  • Years \> 18
  • Informed Content

You may not qualify if:

  • \< 18 years old
  • Renal failure (Creatinine \> 150 µmol/l)
  • Patient in complete arrhythmia due to auricular fibrillation
  • Patient with a Cardiac Basic frequency \> 100 / min
  • Iodine Allergy
  • Patient hospitalized except the frame of the annual systematic monitoring
  • Pregnancy
  • People unable to sign the informed content such as major under supervision
  • Patients non affiliated to the social security system

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pitié Salpêtrière Hospital

Paris, 75013, France

Location

MeSH Terms

Conditions

Coronary Stenosis

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Olivier Barthelemy, MD

    Pitié-Salpêtrière Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 2, 2010

First Posted

May 13, 2010

Study Start

June 1, 2008

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

March 9, 2011

Record last verified: 2011-03

Locations

FR(1)