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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00484380
Other study ID # 2006-04
Secondary ID
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


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
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