Clinical trial NCT00213746: Evaluation of Myocardial Viability by Means of Low-dose Dobutamine Gated SPECT (the DOGS Study)
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Arteriosclerosis
Heart Failure, Congestive
Myocardial Infarction
Myocardial Ischemia
Myocardial Stunning
Keywords: Coronary Arteriosclerosis
Heart Failure, Congestive
Myocardial Infarction
Myocardial Revascularization
Tomography, Emission-Computed, Single-Photon
Dobutamine
Myocardial Stunning
Myocardial Hibernation
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
name: GE Healthcare
name: Fédération Française de Cardiologie
name: Société Française de Cardiologie
name: Société Française de Médecine Nucléaire
First posted: 2005-09-21
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

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.


Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: AZ-VUB
city: Bobigny
country: France
facility: Hopital Avicenne
city: Brest
country: France
facility: CHU de Brest
city: Caen
country: France
facility: University Hospital of Caen
city: Corbeil
country: France
facility: Hopital Sud-Francilien
city: Nancy
country: France
facility: University Hospital of Nancy
city: Paris
country: France
facility: Hopital Européen Georges Pompidou
city: Rouen
country: France
facility: University Hospital of Rouen
Study officials:
affiliation: University Hospital, Rouen
name: Alain Manrique, MD
role: STUDY_CHAIR
affiliation: Central Hospital, Nancy, France
name: Pierre-Yves Marie, MD
role: STUDY_DIRECTOR
affiliation: Free University of Brussels
name: Philippe Franken, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.