Medical Evaluation of Scanner in Coronary Syndrome - Tabular View

Tracking Information

First Received Date ^ICMJE

July 2, 2008

Last Updated Date

January 13, 2009

Start Date ^ICMJE

June 2006

Primary Completion Date

June 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Specificity and sensibility of scanner [ Time Frame: visit 1 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00709709 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Quality of coronary scanner imaging [ Time Frame: visit 1 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Medical Evaluation of Scanner in Coronary Syndrome

Official Title ^ICMJE

Medical and Economic Medical Evaluation of Scan Multislice of Coronary Artery in Exploration of Stable Coronary Syndrome. Comparison With Quantitative Coronarography

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.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Diagnostic, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Condition ^ICMJE

Coronary Syndrome

Intervention ^ICMJE

Procedure: multislice coronary scan

Study Arms / Comparison Groups

Experimental: Scan

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

1500

Completion Date

December 2008

Primary Completion Date

June 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT ID ^ICMJE

NCT00709709

Responsible Party

Mathieu Quintin, Department Clinical Research of Developpement

Study ID Numbers ^ICMJE

P060105

Study Sponsor ^ICMJE

Assistance Publique - Hôpitaux de Paris

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Pascal Gueret, PUPH

Assistance Publique - Hôpitaux de Paris

Information Provided By

Assistance Publique - Hôpitaux de Paris

Verification Date

July 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP