Evaluation of Myocardial Viability by Means of Low-Dose Dobutamine Gated SPECT (the DOGS Study)
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Purpose
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 |
|---|
|
Coronary Arteriosclerosis Heart Failure, Congestive Myocardial Infarction Myocardial Ischemia Myocardial Stunning |
| Study Type: | Observational |
| Study Design: | Time Perspective: 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. |
Eligibility| 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:
- Documented coronary artery disease
- Left ventricular dysfunction (LVEF < 50%)
- Patients referred to the Nuclear Medicine department for myocardial viability assessment
- Sinus Rhythm
- Acceptance of a 6-month follow-up
- Signed informed consent
Exclusion Criteria:
- Recent acute coronary syndrome (< 21 days)
- Atrial Fibrillation or significant arrhythmias
- Implanted pacemaker
- Contra indication to dobutamine
- Non ischaemic cardiomyopathy
- Pregnancy
Contacts and Locations| Belgium | |
| AZ-VUB | |
| Brussels, Belgium, B 1090 | |
| France | |
| Hopital Avicenne | |
| Bobigny, France, 93009 | |
| CHU de Brest | |
| Brest, France, 29200 | |
| University Hospital of Caen | |
| Caen, France, 14000 | |
| Hopital Sud-Francilien | |
| Corbeil, France, 91100 | |
| University Hospital of Nancy | |
| Nancy, France, 54037 | |
| Hopital Européen Georges Pompidou | |
| Paris, France, 75908 | |
| University Hospital of Rouen | |
| Rouen, France, 76031 | |
| 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 |
More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00213746 History of Changes |
| Other Study ID Numbers: | 2003/011/HP |
| Study First Received: | September 13, 2005 |
| Last Updated: | June 13, 2008 |
| Health Authority: | France: Ministry of Health |
Keywords provided by University Hospital, Rouen:
|
Coronary Arteriosclerosis Heart Failure, Congestive Myocardial Infarction Myocardial Revascularization |
Tomography, Emission-Computed, Single-Photon Dobutamine Myocardial Stunning Myocardial Hibernation |
Additional relevant MeSH terms:
|
Arteriosclerosis Coronary Artery Disease Myocardial Ischemia Heart Failure Infarction Ischemia Myocardial Infarction Myocardial Stunning Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases Coronary Disease Heart Diseases Pathologic Processes Necrosis |
Dobutamine Cardiotonic Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Adrenergic beta-1 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013