NCT00484380

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 6, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 8, 2007

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2007

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

March 16, 2011

Status Verified

March 1, 2011

Enrollment Period

3.3 years

First QC Date

June 6, 2007

Last Update Submit

March 15, 2011

Conditions

Valvular DiseaseCoronary Stenosis

Keywords

Valvular surgeryDiagnostic accuracy of coronary angiographyCoronary stenosisCoronary revascularisation

Outcome Measures

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%.

    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.

    a month at the latest after the signature of consent

Interventions

Coronary scannerPROCEDURE

multislice spiral computed tomography coronary angiography

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pitié Salpêtrière Hospital

Paris, 75013, France

Location

MeSH Terms

Conditions

Coronary Stenosis

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Gérard Helft, MD, PHD

    Pitié-Salpêtrière Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 6, 2007

First Posted

June 8, 2007

Study Start

August 1, 2007

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

March 16, 2011

Record last verified: 2011-03

Locations

FR(1)