Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

December 19, 2003
April 16, 2013
May 2003
December 2008   (final data collection date for primary outcome measure)
Survival free of cardiac hospitalization [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00074724 on ClinicalTrials.gov Archive Site
Left ventricular ejection fraction [ Time Frame: 4 months and 2 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Dobutamine Echocardiography In Patients With Ischemic Heart Failure Evaluated for Revascularization
Dobutamine Echocardiography In Patients With Ischemic Heart Failure Evaluated for Revascularization

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Cardiovascular Diseases
  • Coronary Disease
  • Heart Failure
  • Heart Failure, Congestive
  • Heart Diseases
  • Procedure: Coronary Artery Bypass
    coronary revascularization using arterial or vein conduits
    Other Name: CABG
  • 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: Medical Therapy
    All medical interventions know to improve outcomes in patients with ischemic left ventricular dysfunction.
    Interventions:
    • Drug: Modern medical management
    • Device: Dobutamine echocardiography
    • Drug: Optimal medical therapy
  • Active Comparator: CABG
    Surgical revascularization in conjunction with optimal medical therapy.
    Interventions:
    • Procedure: Coronary Artery Bypass
    • Device: Dobutamine echocardiography
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
319
April 2016
December 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00074724
153, 1R01HL070011-01A1
Yes
Medstar Research Institute
Medstar Research Institute
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Julio Panza Medstar Research Institute
Medstar Research Institute
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP