STICH Trial-Echocardiographic Core Laboratory

Project: Research project

Project Details

Description

The Surgical Treatment for IschemicHeart Failure (STICH) multiccnter internationalrandomized trial addresses two specific
primary hypotheses in patients with clinical heart failure (HF) and left ventricular(LV) dysfunction who have coronary artery
disease (CAD) amenable to surgical revascularization: 1) Coronary artery bypass grafting (CABG) with intensive medical
therapy (MED) improves long-term survival compared to MED alone; 2) In patients with anterior LV dysfunction, surgical
ventricular restoration (SVR) to a more normal LV size improves survival free of subsequent hospitalization for cardiac cause
in comparison to CABG alone. Important secondary endpoints include morbidity, economics, and quality of life. Core
laboratories for cardiac magnetic resonance (CMR), echocardiography (ECHO), neurohormonal/cytokine/genetic (NCG), and
radionuclide (RN) studies will insure consistent testing practices and standardization of data necessary to identify eligible
patients and to address specific questions related to the primary hypotheses.
Over three years, 50 clinical sites will recruit 2,800 consenting patients with HF, LV ejection fraction (EF) < .35, and CAD
amenable to CABG. These patients first will be characterized by angina intensity or presence of left main coronary stenosis as
appropriate for only surgical therapy or either medical or surgical therapy. All patients will be evaluated further for
appropriateness of SVR indicated by an end-systolic volume index (ESVI) > 60 ml/m2 and akincsia >35% of the anterior LV
wall. The 600 patients estimated to be eligible for SVR but ineligible for randomization to medical therapy will be evenly
randomized to CABG with or without SVR. Of the 2,200 consenting patients eligible for medical or surgical therapy, the 1,600
not SVR eligible will be evenly randomized between MED only and MED with CABG. The remaining 600 patients alsoeligible
for SVR will be randomized between three treatments of MED only, or MED + CABG, or MED + CABG + SVR. Registries of
clinical information will be maintained on eligible patients who decline trial entry. At four-month intervals for a minimum of
three years, all randomized patients will be followed by a clinic visit and registry patients will be followed by telephone.
Appropriate subgroups of randomized patients will have core laboratory studies repeated at specified follow-up intervals.
The primary role of the Echo Core Laboratory in the STICH Trial will support the main trial operations by identifying
patients eligible for the trial on the basis of LVEF. Echo testing will also addresss secondary aims of the trial regarding the
outcome of patients with ischemic heart failure after MED, or CABG with or without SVR .
StatusNot started

Funding

  • National Heart, Lung, and Blood Institute: $91,817.00

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