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Medical Evaluation of Scanner in Coronary Syndrome (EVASCAN)

Primary Purpose

Coronary Syndrome

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

multislice coronary scan

About this trial

This is an interventional diagnostic trial for Coronary Syndrome focused on measuring stenosis, coronaropathy, stent, bypass surgery, suspect, known

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

CHU Henri Mondor

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Scan

Outcomes

Primary Outcome Measures

Specificity and sensibility of scanner

Secondary Outcome Measures

Quality of coronary scanner imaging

Full Information

NCT ID

NCT00709709

First Posted

July 2, 2008

Last Updated

November 13, 2014

Sponsor

Assistance Publique - Hôpitaux de Paris

1. Study Identification

Unique Protocol Identification Number

NCT00709709

Brief Title

Medical Evaluation of Scanner in Coronary Syndrome

Acronym

EVASCAN

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2008

Overall Recruitment Status

Completed

Study Start Date

June 2006 (undefined)

Primary Completion Date

June 2008 (Actual)

Study Completion Date

December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Syndrome

Keywords

stenosis, coronaropathy, stent, bypass surgery, suspect, known

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

1500 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Scan

Intervention Type

Procedure

Intervention Name(s)

multislice coronary scan

Intervention Description

multislice coronary scan

Primary Outcome Measure Information:

Title

Specificity and sensibility of scanner

Time Frame

visit 1

Secondary Outcome Measure Information:

Title

Quality of coronary scanner imaging

Time Frame

visit 1

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pascal Gueret, PUPH

Organizational Affiliation

Assistance Publique - Hôpitaux de Paris

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHU Henri Mondor

City

Creteil

ZIP/Postal Code

Country

France

12. IPD Sharing Statement

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Medical Evaluation of Scanner in Coronary Syndrome

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