Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00213746
Status:
COMPLETED
Last Update Posted:
2013-06-18
First Post:
2005-09-13
Brief Title:
Evaluation of Myocardial Viability by Means of Low-dose Dobutamine Gated SPECT the DOGS Study
Sponsor:
University Hospital Rouen
Organization:
University Hospital Rouen
Study Overview
Official Title:
Prediction of Left Ventricular Function Changes Using Low Dose Dobutamine Gated SPECT in Patients Referred for Viability Assessment The DOGS DObutamine Gated SpectStudy
Status:
COMPLETED
Status Verified Date:
2013-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 mcgkgmn 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
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 mcgkgmn 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None