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

NCT00213746 | Completed

• 1 other identifier: 2003/011/HP
• Study Type: observational
• Target: 75
• Locations: 2 countries
• Sites: 8

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.

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• Recent acute coronary syndrome (\< 21 days)
• Atrial Fibrillation or significant arrhythmias
• Implanted pacemaker
• Contra indication to dobutamine
• Non ischaemic cardiomyopathy
• Pregnancy

Sponsors & Collaborators

• University Hospital, Rouen: lead
• Bristol-Myers Squibb: collaborator
• GE Healthcare: collaborator
• Fédération Française de Cardiologie: collaborator
• Société Française de Cardiologie: collaborator
• Société Française de Médecine Nucléaire: collaborator

Study Sites (8)

AZ-VUB

Brussels, B 1090, Belgium

Location

Hopital Avicenne

Bobigny, 93009, France

Location

CHU de Brest

Brest, 29200, France

Location

University Hospital of Caen

Caen, 14000, France

Location

Hopital Sud-Francilien

Corbeil, 91100, France

Location

University Hospital of Nancy

Nancy, 54037, France

Location

Hopital Européen Georges Pompidou

Paris, 75908, France

Location

University Hospital of Rouen

Rouen, 76031, France

Location

Related 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. doi: 10.1016/s0735-1097(02)01726-6.

  PMID: 11923039 BACKGROUND

• 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.

  PMID: 10541828 BACKGROUND

• 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.

  PMID: 10805115 BACKGROUND

• 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.

  PMID: 11909565 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease; Heart Failure; Myocardial Infarction; Myocardial Ischemia; Myocardial Stunning

Condition Hierarchy (Ancestors)

Coronary Disease; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Signs and Symptoms

Study Officials

• Alain Manrique, MD

  University Hospital, Rouen

  STUDY CHAIR

• Pierre-Yves Marie, MD

  Central Hospital, Nancy, France

  STUDY DIRECTOR

• Philippe Franken, MD

  Free University of Brussels

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: October 1, 2003
• Study Completion: December 1, 2005
• Last Updated: June 18, 2013

Record last verified: 2013-06

Locations

FR (7); BE (1)