STICH Trial-Echocardiographic Core Laboratory

Project: Research project

Description

DESCRIPTION (provided by applicant):
The Surgical Treatment for Ischemic Heart Failure (STICH) multicenter
international randomized 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
ensure 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) 60
ml/m2 and akinesia >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 also eligible 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 clinical 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.
In the patients randomized to MED with or without CABG, CABG with MED is
hypothesized to demonstrate a >20% reduction in the primary endpoint of all-cause
death with an 89% power from the projected 25% three-year mortality for
MED. In the SVR-eligible patients, CABG + SVR is hypothesized to show a 20%
advantage with 90% power in the endpoint of survival free of hospitalization
for cardiac cause projected to be 50% at three years in patients receiving
CABG without SVR. Definition of efficacy of potential therapies and their
mechanisms of benefit by the STICH Trial is certain to inform future choice of
therapy and thereby extend and improve the quality of lives of millions of
patients who now suffer from ischemic HF.
StatusFinished
Effective start/end date1/1/026/30/09

Funding

  • National Institutes of Health: $195,238.00
  • National Institutes of Health: $309,741.00
  • National Institutes of Health: $306,751.00
  • National Institutes of Health: $346,180.00
  • National Institutes of Health: $61,582.00
  • National Institutes of Health: $91,817.00
  • National Institutes of Health: $116,998.00

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Coronary Artery Bypass
Heart Failure
Therapeutics
Left Ventricular Dysfunction
Survival
Treatment Failure
Random Allocation
Registries
Telephone
Stroke Volume
Echocardiography
Radioisotopes
Magnetic Resonance Spectroscopy
Inpatients
Coronary Artery Disease
Economics
Quality of Life
Cytokines
Morbidity
Mortality

ASJC

  • Medicine(all)