Evaluation of Myocardial Viability by Means of Low-dose Dobutamine Gated SPECT (the DOGS Study)
Study Details
Study Description
Brief Summary
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 or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Inclusion Criteria:
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Documented coronary artery disease
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Left ventricular dysfunction (LVEF < 50%)
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Patients referred to the Nuclear Medicine department for myocardial viability assessment
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Sinus Rhythm
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Acceptance of a 6-month follow-up
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Signed informed consent
Exclusion Criteria:
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Recent acute coronary syndrome (< 21 days)
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Atrial Fibrillation or significant arrhythmias
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Implanted pacemaker
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Contra indication to dobutamine
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Non ischaemic cardiomyopathy
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Pregnancy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | AZ-VUB | Brussels | Belgium | B 1090 | |
| 2 | Hopital Avicenne | Bobigny | France | 93009 | |
| 3 | CHU de Brest | Brest | France | 29200 | |
| 4 | University Hospital of Caen | Caen | France | 14000 | |
| 5 | Hopital Sud-Francilien | Corbeil | France | 91100 | |
| 6 | University Hospital of Nancy | Nancy | France | 54037 | |
| 7 | Hopital Européen Georges Pompidou | Paris | France | 75908 | |
| 8 | University Hospital of Rouen | Rouen | France | 76031 |
Sponsors and Collaborators
- University Hospital, Rouen
- Bristol-Myers Squibb
- GE Healthcare
- Fédération Française de Cardiologie
- Société Française de Cardiologie
- Société Française de Médecine Nucléaire
Investigators
- Study Chair: Alain Manrique, MD, University Hospital, Rouen
- Study Director: Pierre-Yves Marie, MD, Central Hospital, Nancy, France
- Study Director: Philippe Franken, MD, Free University of Brussels
Study Documents (Full-Text)
None provided.More Information
Publications
- Allman KC, Shaw LJ, Hachamovitch R, Udelson JE. Myocardial viability testing and impact of revascularization on prognosis in patients with coronary artery disease and left ventricular dysfunction: a meta-analysis. J Am Coll Cardiol. 2002 Apr 3;39(7):1151-8.
- Everaert H, Vanhove C, Franken PR. Effect of beta-blockade on low-dose dobutamine-induced changes in left ventricular function in healthy volunteers: assessment by gated SPET myocardial perfusion scintigraphy. Eur J Nucl Med. 2000 Apr;27(4):419-24.
- Everaert H, Vanhove C, Franken PR. Effects of low-dose dobutamine on left ventricular function in normal subjects as assessed by gated single-photon emission tomography myocardial perfusion studies. Eur J Nucl Med. 1999 Oct;26(10):1298-303.
- Leoncini M, Sciagrà R, Maioli M, Bellandi F, Marcucci G, Sestini S, Chiocchini S, Dabizzi RP. Usefulness of dobutamine Tc-99m sestamibi-gated single-photon emission computed tomography for prediction of left ventricular ejection fraction outcome after coronary revascularization for ischemic cardiomyopathy. Am J Cardiol. 2002 Apr 1;89(7):817-21.
- 2003/011/HP