Medical Evaluation of Scanner in Coronary Syndrome (EVASCAN)

This study has been completed.
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00709709
First received: July 2, 2008
Last updated: January 13, 2009
Last verified: July 2008
  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

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


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
Experimental: 1
Scan
Procedure: multislice coronary scan
multislice coronary scan
Other Name: 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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

Keywords provided by Assistance Publique - Hôpitaux de Paris:
stenosis
coronaropathy
stent
bypass surgery
suspect
known

ClinicalTrials.gov processed this record on August 18, 2014