The Surgical Treatment for Jschemic Heart Failure (STICH) multicenter 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 intensivemedical therapy (MED) improves long-term survivalcompared 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, echocardiography, neurohormonal/cytokine/genetic, and radionuclide 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 < .35, and CAD amenable to CABG. These patients will first be characterized by angina intensity or presence of left main coronary stenosis as appropriate for only surgical therapy, or for either medical or surgical therapy. All patients will be evaluated further for appropriateness of SVR, indicated by an end-systolic volume index > 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 randomized in equal proportions 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 randomized in equal proportions to MED only or MED with CABG. The remaining 600 patients also eligible for SVR will be randomized to MED only, MED + CABG, or MED + CABG + SVR. A registry 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. This proposal contains the plans for the Statistical and Data Coordinating Center (SDCC) for the trial, which will perform the following major functions: 1) contribute to all phases of study planning; 2) coordinate the preparation of data collection forms and a manual of operations; 3) provide training/guidance in data collection procedures; 4) coordinate the randomization of patients; 5) organize the flow and management of all patient data; 6) establish high standards of quality control for data management; 7) prepare regular status reports for the study's clinical leadership, core laboratories, and all study committees; 8) perform appropriate statistical analyses of study data; and 9) participate in the preparation of study publications. Through the services it provides, the SDCC will be a vital resource in the execution of this clinical trial. PERFORMANCt bi It(S)(organ/zaf/on, city, state) Duke University, Durham, NC KEY PERSONNEL. See instructions on Page 11. Use continuation pages as needed to provide the required information in the format shown below. Name Organization Role on Project Kerry L. Lee, Ph.D. Duke University Statistical Principal Investigator Victor Hassleblad, Ph.D. Duke University Statistical Co-Investigator PHS 398 (Rev. 4/98) Page 2 BB Number pages consecutively at the bottom throughout the application. Do not use suffixes such as 3a, 3b. CC '' Principal Investigator/Program Director (Last, first, middle): Lee, Kerry L. Type the name of the principal investigatol^^gram director at the top of each printed page and eaHW^co
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