Medical Evaluation of Scanner in Coronary Syndrome

NCT ID: NCT00709709

Last Updated: 2014-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2008-12-31

Brief Summary

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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

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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.

Conditions

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Coronary Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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1

Scan

Group Type EXPERIMENTAL

multislice coronary scan

Intervention Type PROCEDURE

multislice coronary scan

Interventions

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multislice coronary scan

multislice coronary scan

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pascal Gueret, PUPH

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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CHU Henri Mondor

Créteil, , France

Site Status

Countries

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France

Other Identifiers

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P060105

Identifier Type: -

Identifier Source: org_study_id