The Scanner in the Coronary Evaluation

Not Applicable

Completed

• Conditions: Valvular Disease; Coronary Stenosis

• Registration Number: NCT00484380
• Lead Sponsor: French Cardiology Society

Brief Summary

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.

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 Timeline

• Study First Submitted: 2007-06-06
• Study First Submitted QC: 2007-06-06
• Study First Posted: 2007-06-08
• Study Start: 2007-08
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2011-03
• Last Update Submitted: 2011-03-15
• Last Update Posted: 2011-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Pitié Salpêtrière Hospital; 🇫🇷 Paris, France