Medical Evaluation of Scanner in Coronary Syndrome - Full Text View

Sponsored by:	Assistance Publique - Hôpitaux de Paris
Information provided by:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00709709

Purpose

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.

Condition	Intervention
Coronary Syndrome	Procedure: multislice coronary scan

MedlinePlus related topics: Nuclear Scans

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Medical and Economic Medical Evaluation of Scan Multislice of Coronary Artery in Exploration of Stable Coronary Syndrome. Comparison With Quantitative Coronarography

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Enrollment:	1500
Study Start Date:	June 2006
Study Completion Date:	December 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Scan	Procedure: multislice coronary scan multislice coronary scan

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00709709

Locations

France
CHU Henri Mondor
Creteil, France, 94

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

Principal Investigator:

Pascal Gueret, PUPH

Assistance Publique - Hôpitaux de Paris

More Information

Responsible Party:	Department Clinical Research of Developpement ( Mathieu Quintin )
Study ID Numbers:	P060105
Study First Received:	July 2, 2008
Last Updated:	January 13, 2009
ClinicalTrials.gov Identifier:	NCT00709709
Health Authority:	France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:

stenosis
coronaropathy
stent

bypass surgery
suspect
known

Study placed in the following topic categories:

Constriction, Pathologic

Additional relevant MeSH terms:

Pathologic Processes
Disease
Syndrome

ClinicalTrials.gov processed this record on January 14, 2009