Medical Evaluation of Scanner in Coronary Syndrome (EVASCAN)

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Coronary Syndrome

Treatments: Procedure: multislice coronary scan

Study type: Interventional

Funder types: Other

Identifiers

NCT00709709

P060105

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,500 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,500 participants in 1 patient group

1

Experimental group

Description:

Scan

Treatment:

Procedure: multislice coronary scan