Back to resultsThe Scanner in the Coronary Evaluation
Primary Purpose
Valvular Disease, Coronary Stenosis
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Coronary scanner
Sponsored by
About this trial
This is an interventional diagnostic trial for Valvular Disease focused on measuring Valvular surgery, Diagnostic accuracy of coronary angiography, Coronary stenosis, Coronary revascularisation
Eligibility Criteria
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
Sites / Locations
- Pitié Salpêtrière Hospital
Outcomes
Primary Outcome Measures
The diagnostic accuracy of coronary scanner (sensitivity, specificity, positive and negative predictive values) in the detection of the coronary stenosis higher than 50%.
Secondary Outcome Measures
The diagnostic accuracy of coronary scanner to detect the patients requiring or not a coronary revascularisation in more of the valvular surgery.
Full Information
NCT ID
NCT00484380
First Posted
June 6, 2007
Last Updated
March 15, 2011
Sponsor
French Cardiology Society
Collaborators
French Federation of Cardiology
1. Study Identification
Unique Protocol Identification Number
NCT00484380
Brief Title
The Scanner in the Coronary Evaluation
Official Title
Contribution of the Scanner in the Coronary Evaluation Before Valvular Replacement
Study Type
Interventional
2. Study Status
Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
French Cardiology Society
Collaborators
French Federation of Cardiology
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Valvular Disease, Coronary Stenosis
Keywords
Valvular surgery, Diagnostic accuracy of coronary angiography, Coronary stenosis, Coronary revascularisation
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Coronary scanner
Intervention Description
multislice spiral computed tomography coronary angiography
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gérard Helft, MD, PHD
Organizational Affiliation
Pitié-Salpêtrière Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pitié Salpêtrière Hospital
City
Paris
ZIP/Postal Code
75013
Country
France
12. IPD Sharing Statement
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