The Scanner in the Coronary Evaluation

Coronary Stenosis Clinical Trial

Official title:

Contribution of the Scanner in the Coronary Evaluation Before Valvular Replacement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00484380
• Other study ID #: 2006-04
• Status: Completed
• Phase: N/A
• First received: June 6, 2007
• Last updated: March 15, 2011
• Start date: August 2007
• Est. completion date: December 2010

Study information

• Verified date: March 2011
• Source: French Cardiology Society
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Coronary Stenosis
• Valvular Disease

Intervention

Procedure:
• Coronary scanner
multislice spiral computed tomography coronary angiography

Locations

Country	Name	City	State
France	Pitié Salpêtrière Hospital	Paris

Sponsors (2)

Lead Sponsor	Collaborator
French Cardiology Society	French Federation of Cardiology

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes