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CompletedNCT00484380Updated Mar 16, 2011

The Scanner in the Coronary Evaluation

An interventional study of Coronary scanner in Valvular Disease and Coronary Stenosis, sponsored by French Cardiology Society. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-03-16.

Sponsored by French Cardiology Society · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
66
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Valvular Disease
  • Coronary Stenosis

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Keywords

  • Valvular surgery
  • Diagnostic accuracy of coronary angiography
  • Coronary stenosis
  • Coronary revascularisation
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In context

Coronary Stenosis

302 studies on the registry are indexed under Coronary Stenosis; 63 are open to participants now.

This study's enrollment of 66 is below the median of 200 across 160 interventional studies indexed under Coronary Stenosis.

Browse Coronary Stenosis studies →

Lead sponsor

French Cardiology Society is the lead sponsor of 84 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients scheduled for valve surgery who need a conventional coronary angiography
  • Informed Content
  • Patients affiliated to the social security system

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
66 participants (actual)

Interventions

  • ProcedureCoronary scanner

    multislice spiral computed tomography coronary angiography

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What researchers measure

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

07

Study locations

1 site
  • Pitié Salpêtrière Hospital
    Paris, 75013, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 16, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00484380
Lead sponsor
French Cardiology Society
Collaborators
French Federation of Cardiology
First posted
Jun 8, 2007
Start date
Aug 2007
Primary completion
Dec 2010
Completion
Dec 2010
Last update
Mar 16, 2011

Study contacts

Gérard Helft, MD, PHD
principal investigator · Pitié-Salpêtrière Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2011. You cannot join it, but the record below documents what was studied.

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