Stress Multidetector Computed Tomography (MDCT) an New Diagnostic Tool for Myocardial Disease
Recruitment status was Recruiting
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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 |
- 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 ]
- 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 ]
| Estimated Enrollment: | 36 |
| Study Start Date: | July 2009 |
| Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
-
Other: coronary dual source computed tomography (DSCT)
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 |
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| Contact: Alexis Jacquier | alexis.jacquier@ap-hm.fr |
| France | |
| Assistance Publique-Hôpitaux de Marseille | Recruiting |
| Marseille, France | |
| Contact: Alexis Jacquier alexis.jacquier@ap-hm.fr | |
| Principal Investigator: Alexis Jacquier | |
| Principal Investigator: | Alexis Jacquier | Assistance Publique-Hôpitaux de Marseille |
More Information
No publications provided
| Responsible Party: | Assistance Publique-Hôpitaux de Marseille, Direction de la recherche |
| ClinicalTrials.gov Identifier: | NCT00949520 History of Changes |
| Other Study ID Numbers: | 2009/12, 2009-A00364-53 |
| Study First Received: | July 29, 2009 |
| Last Updated: | October 19, 2009 |
| 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:
|
Myocardial Ischemia Cardiomyopathies Heart Diseases Cardiovascular Diseases Vascular Diseases 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 June 18, 2013