Evaluation of Myocardial Viability by Means of Low-dose Dobutamine Gated SPECT (the DOGS Study)

Myocardial Infarction Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00213746
• Other study ID #: 2003/011/HP
• Status: Completed
• Phase: N/A
• First received: September 13, 2005
• Last updated: June 17, 2013
• Start date: October 2003
• Est. completion date: December 2005

Study information

• Verified date: June 2013
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Arteriosclerosis
• Coronary Arteriosclerosis
• Coronary Artery Disease
• Heart Failure
• Heart Failure, Congestive
• Infarction
• Myocardial Infarction
• Myocardial Ischemia
• Myocardial Stunning

Locations

Country	Name	City	State
Belgium	AZ-VUB	Brussels
France	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

Sponsors (6)

Lead Sponsor	Collaborator
University Hospital, Rouen	Bristol-Myers Squibb, Fédération Française de Cardiologie, GE Healthcare, Société Française de Cardiologie, Société Française de Médecine Nucléaire

Countries where clinical trial is conducted

Belgium,  France, 

References & Publications (4)

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. — View 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. — View 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. — View Citation

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. — View Citation