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

NCT00213746 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 75

Last updated 2013-06-18

No results posted yet for this study

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

Sponsors & Collaborators

  • Bristol-Myers Squibb

    collaborator INDUSTRY
  • GE Healthcare

    collaborator INDUSTRY
  • Fédération Française de Cardiologie

    collaborator OTHER
  • Société Française de Cardiologie

    collaborator OTHER
  • Société Française de Médecine Nucléaire

    collaborator UNKNOWN
  • University Hospital, Rouen

    lead OTHER

Principal Investigators

  • Alain Manrique, MD · University Hospital, Rouen

  • Pierre-Yves Marie, MD · Central Hospital, Nancy, France

  • Philippe Franken, MD · Free University of Brussels

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-10-31
Completion
2005-12-31

Countries

  • Belgium
  • France

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00213746 on ClinicalTrials.gov