NCT00709709

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2006

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 2, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 3, 2008

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

November 14, 2014

Status Verified

July 1, 2008

Enrollment Period

2 years

First QC Date

July 2, 2008

Last Update Submit

November 13, 2014

Conditions

Coronary Syndrome

Keywords

stenosiscoronaropathystentbypass surgerysuspectknown

Outcome Measures

Primary Outcomes (1)

  • Specificity and sensibility of scanner

    visit 1

Secondary Outcomes (1)

  • Quality of coronary scanner imaging

    visit 1

Study Arms (1)

1

EXPERIMENTAL

Scan

Procedure: multislice coronary scan

Interventions

multislice coronary scanPROCEDURE

multislice coronary scan

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Henri Mondor

Créteil, 94, France

Location

MeSH Terms

Conditions

Angina, UnstableConstriction, Pathologic

Condition Hierarchy (Ancestors)

Angina PectorisMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPathological Conditions, Anatomical

Study Officials

  • Pascal Gueret, PUPH

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2008

First Posted

July 3, 2008

Study Start

June 1, 2006

Primary Completion

June 1, 2008

Study Completion

December 1, 2008

Last Updated

November 14, 2014

Record last verified: 2008-07

Locations

FR(1)