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

This study has been completed.
Sponsor:
Collaborators:
Bristol-Myers Squibb
GE Healthcare
Fédération Française de Cardiologie
Société Française de Cardiologie
Société Française de Médecine Nucléaire
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT00213746
First received: September 13, 2005
Last updated: June 17, 2013
Last verified: June 2013
  Purpose

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
Coronary Arteriosclerosis
Heart Failure, Congestive
Myocardial Infarction
Myocardial Ischemia
Myocardial Stunning

Study Type: Observational
Study Design: Time Perspective: Prospective
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.

Resource links provided by NLM:


Further study details as provided by University Hospital, Rouen:

Estimated Enrollment: 75
Study Start Date: October 2003
Estimated Study Completion Date: December 2005
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00213746

Locations
Belgium
AZ-VUB
Brussels, Belgium, B 1090
France
Hopital Avicenne
Bobigny, France, 93009
CHU de Brest
Brest, France, 29200
University Hospital of Caen
Caen, France, 14000
Hopital Sud-Francilien
Corbeil, France, 91100
University Hospital of Nancy
Nancy, France, 54037
Hopital Européen Georges Pompidou
Paris, France, 75908
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 University Hospital, Nancy
Study Director: Philippe Franken, MD Free University of Brussels
  More Information

Publications:
Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT00213746     History of Changes
Other Study ID Numbers: 2003/011/HP
Study First Received: September 13, 2005
Last Updated: June 17, 2013
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Rouen:
Coronary Arteriosclerosis
Heart Failure, Congestive
Myocardial Infarction
Myocardial Revascularization
Tomography, Emission-Computed, Single-Photon
Dobutamine
Myocardial Stunning
Myocardial Hibernation

Additional relevant MeSH terms:
Arteriosclerosis
Atherosclerosis
Coronary Artery Disease
Heart Failure
Infarction
Myocardial Infarction
Myocardial Ischemia
Myocardial Stunning
Arterial Occlusive Diseases
Cardiovascular Diseases
Coronary Disease
Heart Diseases
Ischemia
Necrosis
Pathologic Processes
Vascular Diseases
Dobutamine
Adrenergic Agents
Adrenergic Agonists
Adrenergic beta-1 Receptor Agonists
Adrenergic beta-Agonists
Autonomic Agents
Cardiotonic Agents
Cardiovascular Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents

ClinicalTrials.gov processed this record on October 29, 2014