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Completed

NCT Number: NCT00484380

The Scanner in the Coronary Evaluation

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.

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Key information

Conditions

Valvular Disease Cardiovascular Diseases Coronary Disease Coronary Stenosis Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pitié Salpêtrière Hospital

Paris, 75013, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Coronary scanner

Procedure

multislice spiral computed tomography coronary angiography

Primary outcomes

  1. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

French Cardiology Society

Other

Collaborators

  • French Federation of Cardiology

Registry information

Official study title

Contribution of the Scanner in the Coronary Evaluation Before Valvular Replacement

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Jun 8, 2007
Registry last updated
Mar 16, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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