Medical Evaluation of Scanner in Coronary Syndrome

Not Applicable

Completed

• Conditions: Coronary Syndrome
• Interventions: Procedure: multislice coronary scan

• Registration Number: NCT00709709
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

Many recent publications have reported encouraging results on diagnostic cardiac multislice CT performance in 1) coronary artery disease, 2) coronary arterial bypass graft potency and 3) intrastent restenosis.

These single center studies were made on a limited number of patients (range, 50-130) and focused mainly on one of the indications mentioned above.

Moreover, results were often given after exclusion of low quality examinations. At last, no study has compared the diagnostic performance of the different CT systems '16, 40 and 64) in these populations.

Detailed Description

These single center studies were made on a limited number of patients (range, 50-130) and focused mainly on one of the indications mentioned above.

Moreover, results were often given after exclusion of low quality examinations. At last, no study has compared the diagnostic performance of the different CT systems '16, 40 and 64) in these populations.

Study Timeline

• Study Start: 2006-06
• Primary Completion: 2008-06
• Status Verified: 2008-07
• Study First Submitted: 2008-07-02
• Study First Submitted QC: 2008-07-02
• Study First Posted: 2008-07-03
• Study Completion: 2008-12
• Last Update Submitted: 2014-11-13
• Last Update Posted: 2014-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

• Patients' ≥18 years, of both sexes
• Coronary angiography in patients with suspected of known CAD, instable clinical conditions.
• Clinical status allowing performance of coronary angiography 48 à 72h after CT examination
• Informed consent signed by patient

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Exclusion Criteria

• Patients in whom clinical status does not allow delayed coronary angiography
• Irregular heart rate, in particular atrial fibrillation
• Renal insufficiency (serum creatinine >150 µmol/l
• Radiology examination with use of iodin agent with 48h before) CT coronary
• K now intolerance to iodin agents
• Patients unable to hold breathing < 20 seconds
• Pregnancy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	multislice coronary scan	Scan

Primary Outcome Measures

Name	Time	Method
Specificity and sensibility of scanner	visit 1

Secondary Outcome Measures

Name	Time	Method
Quality of coronary scanner imaging	visit 1

Trial Locations

Locations (1)

CHU Henri Mondor; 🇫🇷 Creteil, France