Evaluation of Myocardial Viability by Means of Low-dose Dobutamine Gated SPECT (the DOGS Study)
NCT ID: NCT00213746
Last Updated: 2013-06-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
75 participants
OBSERVATIONAL
2003-10-31
2005-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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
* Atrial Fibrillation or significant arrhythmias
* Implanted pacemaker
* Contra indication to dobutamine
* Non ischaemic cardiomyopathy
* Pregnancy
18 Years
80 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
GE Healthcare
INDUSTRY
Fédération Française de Cardiologie
OTHER
Société Française de Cardiologie
OTHER
Société Française de Médecine Nucléaire
UNKNOWN
University Hospital, Rouen
OTHER
Responsible Party
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Principal Investigators
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Alain Manrique, MD
Role: STUDY_CHAIR
University Hospital, Rouen
Pierre-Yves Marie, MD
Role: STUDY_DIRECTOR
Central Hospital, Nancy, France
Philippe Franken, MD
Role: STUDY_DIRECTOR
Free University of Brussels
Locations
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AZ-VUB
Brussels, , Belgium
Hopital Avicenne
Bobigny, , France
CHU de Brest
Brest, , France
University Hospital of Caen
Caen, , France
Hopital Sud-Francilien
Corbeil, , France
University Hospital of Nancy
Nancy, , France
Hopital Européen Georges Pompidou
Paris, , France
University Hospital of Rouen
Rouen, , France
Countries
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References
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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. doi: 10.1016/s0735-1097(02)01726-6.
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. doi: 10.1007/s002590050586.
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. doi: 10.1007/s002590050525.
Leoncini M, Sciagra 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. doi: 10.1016/s0002-9149(02)02203-8.
Other Identifiers
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2003/011/HP
Identifier Type: -
Identifier Source: org_study_id
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