The Scanner in the Coronary Evaluation - Full Text View

Sponsors and Collaborators:	French Cardiology Society French Federation of Cardiology
Information provided by:	French Cardiology Society
ClinicalTrials.gov Identifier:	NCT00484380

Purpose

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.

Condition	Intervention
Valvular Disease Coronary Stenosis	Procedure: Coronary scanner

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Efficacy Study
Official Title:	Contribution of the Scanner in the Coronary Evaluation Before Valvular Replacement

Further study details as provided by French Cardiology Society:

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%. [ Time Frame: at inclusion ]

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. [ Time Frame: at inclusion ]

Estimated Enrollment:	50
Study Start Date:	June 2007
Estimated Study Completion Date:	June 2008

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00484380

Contacts

Contact: Gérard Helft, MD, PhD

+33(0) 1 42 16 28 92

gerard.helft@psl.ap-hop-paris.fr

Locations

France
Pitié Salpêtrière Hospital	Recruiting
Paris, France, 75013
Contact: Gérard Helft, MD, PhD +33(0) 1 42 16 28 92 gerard.helft@psl.ap-hop-paris.fr
Principal Investigator: Gérard Helft, MD, PhD
Sub-Investigator: Claude Le Feuvre
Sub-Investigator: Olivier Barthelemy
Sub-Investigator: Philippe Cluzel
Sub-Investigator: Farzin Beygui
Sub-Investigator: Jean-Philippe Metzger, MD,PhD

Sponsors and Collaborators

French Cardiology Society

French Federation of Cardiology

Investigators

Principal Investigator:

Gérard Helft, MD, PHD

Pitié Salpêtrière Hospital

More Information

Study ID Numbers:	2006-04
Study First Received:	June 6, 2007
Last Updated:	December 1, 2008
ClinicalTrials.gov Identifier:	NCT00484380
Health Authority:	France: Ministry of Health

Keywords provided by French Cardiology Society:

Valvular surgery
Diagnostic accuracy of coronary angiography
Coronary stenosis
Coronary revascularisation

Study placed in the following topic categories:

Coronary Disease
Heart Diseases
Myocardial Ischemia
Vascular Diseases

Constriction, Pathologic
Ischemia
Coronary Stenosis
Coronary Artery Disease

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009