Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00074724
Status:
COMPLETED
Last Update Posted:
2021-04-08
First Post:
2003-12-19
Brief Title:
Dobutamine Echocardiography In Patients With Ischemic Heart Failure Evaluated for Revascularization
Sponsor:
Medstar Health Research Institute
Organization:
Medstar Health Research Institute
Study Overview
Official Title:
Dobutamine Echocardiography In Patients With Ischemic Heart Failure Evaluated for Revascularization
Status:
COMPLETED
Status Verified Date:
2016-06
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:
DECIPHER
Brief Summary:
To define the role of the assessment of myocardial viability with dobutamine echocardiography DE in the clinical evaluation and selection of the best treatment for a high-risk subset of patients with coronary artery disease
Detailed Description:
BACKGROUND
The number of individuals presenting with coronary artery disease CAD with impaired left ventricular LV function measured as ejection fraction EF35 and clinical evidence of heart failure HF continues to increase Patients with these conditions face the need for continuous and intensive medical management and poor quality of life The STICH trial is designed to compare medical management to surgical revascularization in these patients STICHs design includes myocardial function determination by several methods The timely and important question of myocardial viability when function is poor is being examined using radionuclide methods However there is no consensus on the best technique to determine myocardial viability or data to support this assessment as a potential determinant of prognosis following surgery DECIPHER STICH adds dobutamine echocardiography DE for myocardial viability measurement to the parent trial The study is of significance by addressing an important question and adding data for a technique that bears approximately half the cost of radionuclide methods Furthermore the revised design will allow for randomized and blinded evaluations of different treatment modalities according to myocardial viability determined by two different techniques
DESIGN NARRATIVE
The Dobutamine Echocardiography in Patients with Ischemic Heart failure Evaluated for Revascularization Study as part of the Surgical Treatment for Ischemic Heart Failure Trial DECIPHER-STICH is designed to address the hypothesis that assessment of myocardial viability with dobutamine echocardiography DE in patients with coronary artery disease CAD left ventricular LV dysfunction and heart failure HF identifies the patients who derive the greatest survival benefit from surgical revascularization over medical therapy In addition this study will determine the value of DE for the prediction of recovery of LV function following revascularization the clinical value of DE relative to that of radionuclide techniques used for the same purpose and the relationship between abnormal LV size and shape and the contractile reserve of dysfunctional myocardium
DECIPHER-STICH is an ancillary study to the large-scale STICH trial a multicenter international randomized study designed to define the role of coronary artery bypass grafting CABG and surgical ventricular restoration SVR in the treatment of HF in patients with CAD and LV dysfunction In previous studies DE has compared favorably to other methods for the detection of viable myocardium The widespread availability of echocardiography and the possibility of simultaneously deriving information about structural abnormalities eg thrombi valve function and intracardiac pressures in addition to the real-time assessment of regional and global systolic function make DE particularly useful for the comprehensive evaluation of CAD patients with LV dysfunction Because patients in the STICH trial will also undergo radionuclide tests the DECIPHER-STICH study will allow a comparison of the most commonly used techniques for assessment of myocardial viability Patients recruited into the STICH trial will be invited to participate in the DECIPHER-STICH study and asked to sign a separate consent form prior to the randomized assignment of therapy Forty centers from North America and Europe recruiting patients into the STICH trial have agreed to take part in the DECIPHER-STICH study A total of 1450 of the 2800 patients enrolled into the STICH trial will undergo DE prior to treatment DECIPHER-STICH will address the hypothesis of greater beneficial effect of coronary artery bypass surgery CABG over medical therapy alone on 3-year survival rate with 80 power to detect a 25-to-125 reduction in all-cause mortality in patients with viable myocardium In addition the study will have 99 power to address three important secondary hypotheses The results of this study will provide definitive information regarding the value of assessing myocardial viability with DE and significant clinical implications for the selection of patients with CAD LV dysfunction and HF who are most likely to benefit from surgical revascularization
The number of individuals presenting with coronary artery disease CAD with impaired left ventricular LV function measured as ejection fraction EF35 and clinical evidence of heart failure HF continues to increase Patients with these conditions face the need for continuous and intensive medical management and poor quality of life The STICH trial is designed to compare medical management to surgical revascularization in these patients STICHs design includes myocardial function determination by several methods The timely and important question of myocardial viability when function is poor is being examined using radionuclide methods However there is no consensus on the best technique to determine myocardial viability or data to support this assessment as a potential determinant of prognosis following surgery DECIPHER STICH adds dobutamine echocardiography DE for myocardial viability measurement to the parent trial The study is of significance by addressing an important question and adding data for a technique that bears approximately half the cost of radionuclide methods Furthermore the revised design will allow for randomized and blinded evaluations of different treatment modalities according to myocardial viability determined by two different techniques
DESIGN NARRATIVE
The Dobutamine Echocardiography in Patients with Ischemic Heart failure Evaluated for Revascularization Study as part of the Surgical Treatment for Ischemic Heart Failure Trial DECIPHER-STICH is designed to address the hypothesis that assessment of myocardial viability with dobutamine echocardiography DE in patients with coronary artery disease CAD left ventricular LV dysfunction and heart failure HF identifies the patients who derive the greatest survival benefit from surgical revascularization over medical therapy In addition this study will determine the value of DE for the prediction of recovery of LV function following revascularization the clinical value of DE relative to that of radionuclide techniques used for the same purpose and the relationship between abnormal LV size and shape and the contractile reserve of dysfunctional myocardium
DECIPHER-STICH is an ancillary study to the large-scale STICH trial a multicenter international randomized study designed to define the role of coronary artery bypass grafting CABG and surgical ventricular restoration SVR in the treatment of HF in patients with CAD and LV dysfunction In previous studies DE has compared favorably to other methods for the detection of viable myocardium The widespread availability of echocardiography and the possibility of simultaneously deriving information about structural abnormalities eg thrombi valve function and intracardiac pressures in addition to the real-time assessment of regional and global systolic function make DE particularly useful for the comprehensive evaluation of CAD patients with LV dysfunction Because patients in the STICH trial will also undergo radionuclide tests the DECIPHER-STICH study will allow a comparison of the most commonly used techniques for assessment of myocardial viability Patients recruited into the STICH trial will be invited to participate in the DECIPHER-STICH study and asked to sign a separate consent form prior to the randomized assignment of therapy Forty centers from North America and Europe recruiting patients into the STICH trial have agreed to take part in the DECIPHER-STICH study A total of 1450 of the 2800 patients enrolled into the STICH trial will undergo DE prior to treatment DECIPHER-STICH will address the hypothesis of greater beneficial effect of coronary artery bypass surgery CABG over medical therapy alone on 3-year survival rate with 80 power to detect a 25-to-125 reduction in all-cause mortality in patients with viable myocardium In addition the study will have 99 power to address three important secondary hypotheses The results of this study will provide definitive information regarding the value of assessing myocardial viability with DE and significant clinical implications for the selection of patients with CAD LV dysfunction and HF who are most likely to benefit from surgical revascularization
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01HL070011-01A1 | NIH | None | httpsreporternihgovquickSearch1R01HL070011-01A1 |