Dobutamine Echocardiography In Patients With Ischemic Heart Failure Evaluated for Revascularization (DECIPHER)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Medstar Research Institute
ClinicalTrials.gov Identifier:
NCT00074724
First received: December 19, 2003
Last updated: April 16, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention
Cardiovascular Diseases
Coronary Disease
Heart Failure
Heart Failure, Congestive
Heart Diseases
Procedure: Coronary Artery Bypass
Drug: Modern medical management
Device: Dobutamine echocardiography
Drug: Optimal medical therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Dobutamine Echocardiography In Patients With Ischemic Heart Failure Evaluated for Revascularization

Resource links provided by NLM:


Further study details as provided by Medstar Research Institute:

Primary Outcome Measures:
  • Survival free of cardiac hospitalization [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Left ventricular ejection fraction [ Time Frame: 4 months and 2 years ] [ Designated as safety issue: No ]

Enrollment: 319
Study Start Date: May 2003
Estimated Study Completion Date: April 2016
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Medical Therapy
All medical interventions know to improve outcomes in patients with ischemic left ventricular dysfunction.
Drug: Modern medical management
Therapies with evidence-based recommendations.
Other Name: Optimal medical therapy
Device: Dobutamine echocardiography
Incremental dose administration of dobutamine to elicit a contractile response of the myocardium.
Other Name: dobutamine echo
Drug: Optimal medical therapy
All medical interventions known to improve outcomes in patients with ischemic left ventricular dysfunction.
Other Name: MOdern medical therapy
Active Comparator: CABG
Surgical revascularization in conjunction with optimal medical therapy.
Procedure: Coronary Artery Bypass
coronary revascularization using arterial or vein conduits
Other Name: CABG
Device: Dobutamine echocardiography
Incremental dose administration of dobutamine to elicit a contractile response of the myocardium.
Other Name: dobutamine echo

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00074724

Sponsors and Collaborators
Medstar Research Institute
Investigators
Principal Investigator: Julio Panza Medstar Research Institute
  More Information

No publications provided

Responsible Party: Medstar Research Institute
ClinicalTrials.gov Identifier: NCT00074724     History of Changes
Other Study ID Numbers: 153, 1R01HL070011-01A1
Study First Received: December 19, 2003
Last Updated: April 16, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Cardiovascular Diseases
Coronary Disease
Coronary Artery Disease
Heart Diseases
Heart Failure
Myocardial Ischemia
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Dobutamine
Cardiotonic Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents

ClinicalTrials.gov processed this record on September 11, 2014