NCT00949520

Brief Summary

The goal of this study is to evaluate the ability of MDCT under stress to assess myocardial ischemia. There is some preliminary data in the literature showing the ability of MDCT under stress to bring relevant information about myocardial ischemia. Stress MDCT will have several advantages over single photon emission computed tomography (SPECT) imaging namely: shorter acquisition time, lower irradiation dose, lower cost. The feasibility of such experiment is still debated and need to be address in a clinical study.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 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

July 1, 2009

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

July 29, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 30, 2009

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Last Updated

February 25, 2014

Status Verified

February 1, 2014

Enrollment Period

2.3 years

First QC Date

July 29, 2009

Last Update Submit

February 24, 2014

Conditions

Coronary Artery Lesion

Keywords

patientsfunctional evaluationknown coronary artery lesion

Outcome Measures

Primary Outcomes (1)

  • To evaluate the diagnostic potential sensitivity, specificity of coronary DSCT during dipyridamole infusion for the assessment of myocardial ischemia with myocardial single photon emission computed topography (SPECT) as standard of reference.

    1 year

Secondary Outcomes (1)

  • To evaluate the feasibility (presence of artefact, number of coronary segment assessable) of coronary DSCT during dipyridamole injection.

    1 year

Interventions

coronary dual source computed tomography (DSCT)OTHER

coronary dual source computed tomography during dipyridamole injection

Also known as: coronary DSCT
myocardial single photon emission computed topography (SPECT)OTHER

myocardial single photon emission computed topography during dipyridamole injection

Also known as: myocardial SPECT

Eligibility Criteria

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

You may qualify if:

  • Patients who required functional evaluation of a known coronary artery lesion

You may not qualify if:

  • Disorders of the heart rhythm
  • Myocardial infarct dating less than a month
  • Unstable anger
  • Congestive heart failure stages 3 and 4 of NYHA
  • Renal failure
  • Pregnancy and feeding
  • History of anaphylactic reaction in the injection of iodized product

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique-Hôpitaux de Marseille

Marseille, France

Location

Study Officials

  • Alexis Jacquier

    Assistance Publique-Hôpitaux de Marseille

    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 29, 2009

First Posted

July 30, 2009

Study Start

July 1, 2009

Primary Completion

November 1, 2011

Last Updated

February 25, 2014

Record last verified: 2014-02

Locations

FR(1)