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EVASCAN: Medical Evaluation of Scanner in Coronary Syndrome

Sponsor
Assistance Publique - Hôpitaux de Paris (Other)
Overall Status
Completed
CT.gov ID
NCT00709709
Collaborator
(none)
1,500
Enrollment
1
Location
1
Arm
30
Duration (Months)
50
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: multislice coronary scan
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
1500 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Medical and Economic Medical Evaluation of Scan Multislice of Coronary Artery in Exploration of Stable Coronary Syndrome. Comparison With Quantitative Coronarography
Study Start Date :
Jun 1, 2006
Actual Primary Completion Date :
Jun 1, 2008
Actual Study Completion Date :
Dec 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Scan

Procedure: multislice coronary scan
multislice coronary scan

Outcome Measures

Primary Outcome Measures

  1. Specificity and sensibility of scanner [visit 1]

Secondary Outcome Measures

  1. Quality of coronary scanner imaging [visit 1]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00709709
Other Study ID Numbers:
  • P060105
First Posted:
Jul 3, 2008
Last Update Posted:
Nov 14, 2014
Last Verified:
Jul 1, 2008
Keywords provided by Assistance Publique - Hôpitaux de Paris
stenosis
coronaropathy
stent
bypass surgery
suspect
known
Additional relevant MeSH terms:
Syndrome

Study Results

No Results Posted as of Nov 14, 2014