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
  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:
    Procedure: Coronary scanner
    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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Hôpital de la Salpétrière
  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:
Coronary Stenosis
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 19, 2014