Stress Multidetector Computed Tomography (MDCT) an New Diagnostic Tool for Myocardial Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT00949520
First received: July 29, 2009
Last updated: February 24, 2014
Last verified: February 2014

July 29, 2009
February 24, 2014
July 2009
November 2011   (final data collection date for primary outcome measure)
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. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00949520 on ClinicalTrials.gov Archive Site
To evaluate the feasibility (presence of artefact, number of coronary segment assessable) of coronary DSCT during dipyridamole injection. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Stress Multidetector Computed Tomography (MDCT) an New Diagnostic Tool for Myocardial Disease
Dual Source Computed Tomography (DSCT) During Injection of Dipyridamole : a New Technique for Myocardial Ischemia Assessment

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.

Hypothesis: Cardiac dual source computed tomography (DSCT) performed during dipyridamole infusion allows for 1) myocardial perfusion analysis and detection of myocardial ischemia and 2) good quality evaluation (artefact free) of the coronary artery anatomy. Cardiac DSCT during dipyridamole infusion may assess in a single volume acquisition relevant information about coronary anatomy and myocardial ischemia that required today two different examinations each with a cost and side effects. Recently investigators showed on animal models as well as in humans that MDCT during stress test could detect myocardial ischemia.

Purposes: 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. 2) To evaluate the feasibility (presence of artefact, number of coronary segment assessable) of coronary DSCT during dipyridamole injection.

Methods: This prospective study will include patients referred from the department of cardiology of Nord hospital. Inclusion criteria will be: patients who required functional evaluation of a known coronary artery lesion. Patients will be successively include. Each patient will undergo myocardial SPECT and coronary DSCT during dipyridamole injection. Coronary DSCT image analysis will determine the severity and the extension of the ischemic territory. Statistical analysis will determine the reproductibility of the described technique, compared the DSCT with SPECT as standard of reference and determined sensitivity, specificity and predictive values (positive and negative) of the described technique.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Coronary Artery Lesion
  • Other: coronary dual source computed tomography (DSCT)
    coronary dual source computed tomography during dipyridamole injection
    Other Name: coronary DSCT
  • Other: myocardial single photon emission computed topography (SPECT)
    myocardial single photon emission computed topography during dipyridamole injection
    Other Name: myocardial SPECT
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
17
Not Provided
November 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00949520
2009/12, 2009-A00364-53
No
Assistance Publique Hopitaux De Marseille
Assistance Publique Hopitaux De Marseille
Not Provided
Principal Investigator: Alexis Jacquier Assistance Publique-Hôpitaux de Marseille
Assistance Publique Hopitaux De Marseille
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP