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Sponsors and Collaborators: |
University Hospital, Rouen Bristol-Myers Squibb GE Healthcare Fédération Française de Cardiologie Société Française de Cardiologie Société Française de Médecine Nucléaire |
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Information provided by: | University Hospital, Rouen |
ClinicalTrials.gov Identifier: | NCT00213746 |
Viability assessment remains a clinical challenge in patient with coronary artery disease and left ventricular dysfunction. Several imaging modalities are available for evaluating myocardial viability, based either on perfusion or on contractile reserve analysis. Briefly, perfusion analysis is highly sensitive and contractile reserve highly specific. A combined analysis of both perfusion and contractile reserve has been proposed to improve the diagnostic accuracy in patient referred for a revascularization procedure. However, the value of this combined analysis has not been validated in unselected patients referred for viability assessment.
The patients enrolled in the study will undergo a nitrate enhanced rest gated SPECT using a Tc-99m labeled tracer (sestamibi or tetrofosmine) followed by a second gated SPECT acquired during a low-dose dobutamine infusion (10 mcg/kg/mn). All patients will have a 6-month clinical and imaging follow-up, including physical examination and a nitrate enhanced rest gated SPECT using the same radiopharmaceutical. All treatments received during this 6-month period will be recorded, including medical therapy and coronary revascularization (angioplasty, stenting and CABG).
Finally, the value of baseline perfusion and contractile reserve analysis in predicting left ventricular ejection fraction changes at 6-month follow-up will be evaluated.
Condition |
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Coronary Arteriosclerosis Heart Failure, Congestive Myocardial Infarction Myocardial Ischemia Myocardial Stunning |
Study Type: | Observational |
Study Design: | Prospective |
Official Title: | Prediction of Left Ventricular Function Changes Using Low Dose Dobutamine Gated SPECT in Patients Referred for Viability Assessment: The DOGS (DObutamine Gated Spect)Study. |
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
The study population consists with patients with documented coronary artery disease and left ventricular dysfunction (LVEF < 50%)referred to aNuclear Medicine department for myocardial viability assessment
Inclusion Criteria:
Exclusion Criteria:
Belgium | |
AZ-VUB | |
Brussels, Belgium, B 1090 | |
France | |
University Hospital of Rouen | |
Rouen, France, 76031 | |
University Hospital of Nancy | |
Nancy, France, 54037 | |
University Hospital of Caen | |
Caen, France, 14000 | |
Hopital Européen Georges Pompidou | |
Paris, France, 75908 | |
CHU de Brest | |
Brest, France, 29200 | |
Hopital Sud-Francilien | |
Corbeil, France, 91100 | |
Hopital Avicenne | |
Bobigny, France, 93009 |
Study Chair: | Alain Manrique, MD | University Hospital, Rouen |
Study Director: | Pierre-Yves Marie, MD | University Hospital of Nancy |
Study Director: | Philippe Franken, MD | Free University of Brussels |
Study ID Numbers: | 2003/011/HP |
Study First Received: | September 13, 2005 |
Last Updated: | June 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00213746 |
Health Authority: | France: Ministry of Health |
Coronary Arteriosclerosis Heart Failure, Congestive Myocardial Infarction Myocardial Revascularization |
Tomography, Emission-Computed, Single-Photon Dobutamine Myocardial Stunning Myocardial Hibernation |
Arterial Occlusive Diseases Myocardial Stunning Heart Failure Heart Diseases Myocardial Ischemia Vascular Diseases Arteriosclerosis |
Ischemia Dobutamine Coronary Disease Necrosis Infarction Myocardial Infarction Coronary Artery Disease |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic beta-Agonists Adrenergic Agents Cardiotonic Agents Sympathomimetics Physiological Effects of Drugs Cardiovascular Agents |
Protective Agents Pharmacologic Actions Adrenergic Agonists Pathologic Processes Autonomic Agents Therapeutic Uses Cardiovascular Diseases Peripheral Nervous System Agents |