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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00709709
Other study ID # P060105
Secondary ID
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


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
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