Dobutamine Echocardiography In Patients With Ischemic Heart Failure Evaluated for Revascularization

NCT ID: NCT00074724

Last Updated: 2021-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 319 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-05-31
• Study Completion Date: 2017-04-30

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.

Conditions

Cardiovascular Diseases; Coronary Disease; Heart Failure; Heart Failure, Congestive; Heart Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Medical Therapy

All medical interventions know to improve outcomes in patients with ischemic left ventricular dysfunction.

Group Type: ACTIVE_COMPARATOR

Modern medical management

Intervention Type: DRUG

Therapies with evidence-based recommendations.

Dobutamine echocardiography

Intervention Type: DEVICE

Incremental dose administration of dobutamine to elicit a contractile response of the myocardium.

Optimal medical therapy

Intervention Type: DRUG

All medical interventions known to improve outcomes in patients with ischemic left ventricular dysfunction.

CABG

Surgical revascularization in conjunction with optimal medical therapy.

Group Type: ACTIVE_COMPARATOR

Coronary Artery Bypass

Intervention Type: PROCEDURE

coronary revascularization using arterial or vein conduits

Dobutamine echocardiography

Intervention Type: DEVICE

Incremental dose administration of dobutamine to elicit a contractile response of the myocardium.

Interventions

Coronary Artery Bypass

coronary revascularization using arterial or vein conduits

Intervention Type: PROCEDURE

Modern medical management

Therapies with evidence-based recommendations.

Intervention Type: DRUG

Dobutamine echocardiography

Incremental dose administration of dobutamine to elicit a contractile response of the myocardium.

Intervention Type: DEVICE

Optimal medical therapy

All medical interventions known to improve outcomes in patients with ischemic left ventricular dysfunction.

Intervention Type: DRUG

Other Intervention Names

CABG; Optimal medical therapy; dobutamine echo; MOdern medical therapy

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Medstar Health Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julio Panza

Role: PRINCIPAL_INVESTIGATOR

Medstar Health Research Institute

Other Identifiers

1R01HL070011-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

153

Identifier Type: -

Identifier Source: org_study_id