Cardiovascular Diseases, Coronary Disease, Heart Failure, Heart Failure, Congestive, Heart Diseases
Conditions
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 {EF}\<35%), 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. STICH's 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 (e.g., 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 1,450 of the 2,800 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-12.5% 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.
Interventions
PROCEDURECoronary Artery Bypass
coronary revascularization using arterial or vein conduits
DRUGModern medical management
Therapies with evidence-based recommendations.
Incremental dose administration of dobutamine to elicit a contractile response of the myocardium.
DRUGOptimal medical therapy
All medical interventions known to improve outcomes in patients with ischemic left ventricular dysfunction.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Medstar Health Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Enrollment Requirements Inclusion Criteria: * Symptomatic heart failure defined as NYHA Class II - IV (within 3 months of entry) * LV less than 35% defined by CMR or gated SPECT studies * Coronary anatomy suitable for revascularization
Exclusion criteria
* Primary valvular heart disease clearly defined indicating the need for valve repair or replacement * Patients with concurrent cardiogenic shock or requiring inotropic or intra-aortic balloon support * PCI planned for CAD treatment * Acute myocardial infarction within 30 days * More than one prior cardiac operation * Non-cardiac illness with life expectancy of less than 3 years * Non-cardiac illness imposing substantial operative mortality. Patients eligible to enter the study will be further evaluated by the STICH team for SVR eligibility.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survival Free of Cardiac Hospitalization | 3 years |
Secondary
| Measure | Time frame |
|---|---|
| Left Ventricular Ejection Fraction | 4 months and 2 years |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Medical Therapy All medical interventions know to improve outcomes in patients with ischemic left ventricular dysfunction.
Modern medical management: Therapies with evidence-based recommendations.
Dobutamine echocardiography: Incremental dose administration of dobutamine to elicit a contractile response of the myocardium.
Optimal medical therapy: All medical interventions known to improve outcomes in patients with ischemic left ventricular dysfunction. | 0 |
| CABG Surgical revascularization in conjunction with optimal medical therapy.
Coronary Artery Bypass: coronary revascularization using arterial or vein conduits
Dobutamine echocardiography: Incremental dose administration of dobutamine to elicit a contractile response of the myocardium. | 0 |
| Total | 0 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Survival Free of Cardiac Hospitalization
Time frame: 3 years
Population: The PI has left the institution and no results data is available. Efforts were made to contact the PI/study team members, as well as to review data on shared drives, IRB historical records and published resources, but were unsuccessful. No study data are available
Secondary
Left Ventricular Ejection Fraction
Time frame: 4 months and 2 years
Population: The PI has left the institution and no results data is available. Efforts were made to contact the PI/study team members, as well as to review data on shared drives, IRB historical records and published resources, but were unsuccessful. No study data are available