Medical Evaluation of Scanner in Coronary Syndrome

Coronary Syndrome Clinical Trial

— EVASCAN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00709709
• Other study ID #: P060105
• Status: Completed
• Phase: N/A
• First received: July 2, 2008
• Last updated: November 13, 2014
• Start date: June 2006
• Est. completion date: December 2008

Study information

• Verified date: July 2008
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1500
• Est. completion date: December 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Coronary Syndrome
• Syndrome

Intervention

Procedure:
• multislice coronary scan
multislice coronary scan

Locations

Country	Name	City	State
France	CHU Henri Mondor	Creteil

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Specificity and sensibility of scanner		visit 1	No
Secondary	Quality of coronary scanner imaging		visit 1	No