The Scanner in the Coronary Evaluation

March 15, 2011 updated by: French Cardiology Society

Contribution of the Scanner in the Coronary Evaluation Before Valvular Replacement

Conventional coronary angiography is the recommended procedure in detection of coronary stenosis in patients with heart valve disease referred for surgery.The aim of this prospective study is to assess diagnostic accuracy of multislice spiral computed tomography coronary angiography in patients with heart valve disease referred for surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Procedure: Coronary scanner

Detailed Description

The diagnostic accuracy of multislice spiral computed tomography coronary angiography in terms of sensitivity, specificity, negative and positive predictive value, the conventional coronary angiography being the gold standard.50 patients scheduled for valve surgery will be screened to conduct an additional multislice spiral computed tomography.

Study Type

Interventional

Enrollment (Actual)

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

France
- - Paris, France, 75013
    - Pitié Salpêtrière Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Patients scheduled for valve surgery who need a conventional coronary angiography
Informed Content
Patients affiliated to the social security system

Exclusion Criteria:

Instable condition
Arrhythmia including atrial fibrillation
Impaired renal function
Known contrast allergy
Patients unable to hold an apnea during 20 seconds
Pregnancy
Emergency
People unable to sign the informed content such as major under supervision

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: DIAGNOSTIC
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The diagnostic accuracy of coronary scanner (sensitivity, specificity, positive and negative predictive values) in the detection of the coronary stenosis higher than 50%. Time Frame: a month at the latest after the signature of consent	a month at the latest after the signature of consent

Secondary Outcome Measures

Outcome Measure	Time Frame
The diagnostic accuracy of coronary scanner to detect the patients requiring or not a coronary revascularisation in more of the valvular surgery. Time Frame: a month at the latest after the signature of consent	a month at the latest after the signature of consent

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

French Cardiology Society

Collaborators

French Federation of Cardiology

Investigators

Principal Investigator: Gérard Helft, MD, PHD, Pitié-Salpêtrière Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (ACTUAL)

December 1, 2010

Study Completion (ACTUAL)