Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00074724 |
| Other study ID # |
153 |
| Secondary ID |
1R01HL070011-01A |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 2003 |
| Est. completion date |
April 2017 |
Study information
| Verified date |
June 2016 |
| Source |
Medstar Health Research Institute |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
