The Scanner in the Coronary Evaluation

This study has been completed.

Sponsor:

Collaborator:

French Federation of Cardiology

Information provided by:

French Cardiology Society

ClinicalTrials.gov Identifier:

NCT00484380

First received: June 6, 2007

Last updated: March 15, 2011

Last verified: March 2011

History of Changes

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

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic
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: a month at the latest after the signature of consent ] [ Designated as safety issue: No ]

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: a month at the latest after the signature of consent ] [ Designated as safety issue: Yes ]

Enrollment:	66
Study Start Date:	August 2007
Study Completion Date:	December 2010
Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Intervention Details:

multislice spiral computed tomography coronary angiography

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

Locations

France
Pitié Salpêtrière Hospital
Paris, France, 75013

Sponsors and Collaborators

French Cardiology Society

French Federation of Cardiology

Investigators

Principal Investigator:

Gérard Helft, MD, PHD

Pitié Salpêtrière Hospital

More Information

No publications provided

Responsible Party:	Pr Gérard Helft, Hôpital de la Pitié Salpêtrière
ClinicalTrials.gov Identifier:	NCT00484380 History of Changes
Other Study ID Numbers:	2006-04
Study First Received:	June 6, 2007
Last Updated:	March 15, 2011
Health Authority:	France: Ministry of Health

Keywords provided by French Cardiology Society:

Valvular surgery
Diagnostic accuracy of coronary angiography
Coronary stenosis
Coronary revascularisation

Additional relevant MeSH terms:

Constriction, Pathologic
Coronary Stenosis
Pathological Conditions, Anatomical
Coronary Disease

Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013

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