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

NCT ID: NCT00213746

Last Updated: 2013-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-10-31

Study Completion Date

2005-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role collaborator

GE Healthcare

INDUSTRY

Sponsor Role collaborator

Fédération Française de Cardiologie

OTHER

Sponsor Role collaborator

Société Française de Cardiologie

OTHER

Sponsor Role collaborator

Société Française de Médecine Nucléaire

UNKNOWN

Sponsor Role collaborator

University Hospital, Rouen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alain Manrique, MD

Role: STUDY_CHAIR

University Hospital, Rouen

Pierre-Yves Marie, MD

Role: STUDY_DIRECTOR

Central Hospital, Nancy, France

Philippe Franken, MD

Role: STUDY_DIRECTOR

Free University of Brussels

Locations

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AZ-VUB

Brussels, , Belgium

Site Status

Hopital Avicenne

Bobigny, , France

Site Status

CHU de Brest

Brest, , France

Site Status

University Hospital of Caen

Caen, , France

Site Status

Hopital Sud-Francilien

Corbeil, , France

Site Status

University Hospital of Nancy

Nancy, , France

Site Status

Hopital Européen Georges Pompidou

Paris, , France

Site Status

University Hospital of Rouen

Rouen, , France

Site Status

Countries

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Belgium France

References

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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.

Reference Type BACKGROUND
PMID: 11923039 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10541828 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10805115 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11909565 (View on PubMed)

Other Identifiers

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2003/011/HP

Identifier Type: -

Identifier Source: org_study_id

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