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
  Purpose

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.


Condition Intervention
Coronary Artery Lesion
Other: coronary dual source computed tomography (DSCT)
Other: myocardial single photon emission computed topography (SPECT)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Dual Source Computed Tomography (DSCT) During Injection of Dipyridamole : a New Technique for Myocardial Ischemia Assessment

Resource links provided by NLM:


Further study details as provided by Assistance Publique Hopitaux De Marseille:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 17
Study Start Date: July 2009
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    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
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00949520

Locations
France
Assistance Publique-Hôpitaux de Marseille
Marseille, France
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Principal Investigator: Alexis Jacquier Assistance Publique-Hôpitaux de Marseille
  More Information

No publications provided

Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT00949520     History of Changes
Other Study ID Numbers: 2009/12, 2009-A00364-53
Study First Received: July 29, 2009
Last Updated: February 24, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Assistance Publique Hopitaux De Marseille:
patients
functional evaluation
known coronary artery lesion

Additional relevant MeSH terms:
Dipyridamole
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Vasodilator Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on September 22, 2014