Coronary Revascularization in Diabetic Patients

糖尿病患者的冠状动脉血运重建

基本信息

批准号：
7848183
负责人：
Valentin Fuster
金额：
$ 342.86万
依托单位：
ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
依托单位国家：
美国
项目类别：
财政年份：
2004
资助国家：
美国
起止时间：
2004-04-15 至 2011-12-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7848183
关键词：
African American American Blood Vessels Cardiac Cardiovascular system Caucasians Caucasoid Race Chronic Kidney Insufficiency Clinical Clinical Trials Comorbidity Confidence Intervals Coronary Coronary Arteriosclerosis Coronary Artery Bypass Coronary artery Diabetes Mellitus Diagnosis Disease Double-Blind Method Eligibility Determination Enrollment Ensure Evaluation Event Exclusion Criteria Follow-Up Studies Freedom Future Gender Glycoproteins Hispanics Hospitalization Hospitals Individual Infarction Infection Informed Consent Institution Kidney Failure Left Ventricular Ejection Fraction Length of Stay Lesion Morbidity - disease rate Multi-Institutional Clinical Trial Neurocognitive Neurologist Operative Surgical Procedures Outcome Outcome Measure Outcome Study Patients Pharmaceutical Preparations Population Procedures Pump Quality of life Race Radiation therapy Randomized Randomized Clinical Trials Recruitment Activity Relative (related person)Resources Sample Size Sirolimus Stents Stroke Subgroup Surgeon Testing Therapeutic Troponin Unstable angina Writing arm base cerebrovascular clinical research site cognitive function cohort cost effectiveness design diabetic diabetic patient follow-up ilium implantation improved inhibitor/antagonist innovation meetings mortality operation percutaneous coronary intervention prevent primary outcome prospective restenosis standard of care treatment strategy trial comparing

项目摘要

DESCRIPTION (provided by applicant): FREEDOM is a multicenter, prospective, randomized clinical trial comparing coronary artery bypass surgery (CABG) with percutaneous coronary stenting using the Sirolimus-eluting stent in diabetic patients with multivessel disease. The main objective of the study is to compare a multivessel stenting strategy using Sirolimus-eluting stents with CABG with respect to mortality in 5 years of follow-up. The study population will consist of 2300 patients (1150/arm) with diabetes mellitus diagnosed according to the American Diabetes Association, and multivessel coronary artery disease (CAD) (2 or more stenotic lesions in at least 2 major epicardial coronary arteries), amenable to either PCI with stenting or surgical revascularization. All subjects will be screened to ensure that all inclusion and exclusion criteria are fulfilled prior to study entry. A written informed consent will be obtained prior to enrollment in the study. Patients who meet the eligibility criteria will be randomized on a 1:1 basis either to CABG or multivessel stenting using Sirolimus-eluting stents. The primary outcome of the study is the difference in mortality rates between the stent group and the CABG group over the 5-year period. The following secondary endpoints will be assessed: 1) survival functions over years 1, 2, 3 and 4; 2) individual components of MACCE in-hospital at 30 days, 6 months and 12 months; 3) quality of life pre- and post-randomization every 6 months up to 5 years; 4) neuro-cognitive function pre-procedure and 6 months, 1 year and 5 years post-procedure; and 5) cost-effectiveness analyses, hospital length of stay, resource utilization, repeat hospitalization, and repeat revascularization events. We plan to recruit all patients over the course of 18 months at 100 clinical sites.

描述（由申请人提供）： Freedom是一项多中心，前瞻性的，随机的临床试验，比较冠状动脉搭桥手术（CABG）与经皮冠状动脉支架使用Sirolimus洗脱支架在具有多人疾病的糖尿病患者中。该研究的主要目的是比较使用Sirolimus洗脱支架与CABG与5年随访中的死亡率进行多组架支架策略。该研究人群将由2300名患者（1150/ARM）组成，该患者根据美国糖尿病协会诊断为糖尿病，以及多次冠状动脉疾病（CAD）（CAD）（至少2个主要表达冠状动脉动脉中的2个或更多狭窄病变），可用于置于stentsentsnentsnents stentsnent或Surgical Recastasgical Recastasgical Ilastial PCI。将对所有受试者进行筛选，以确保在研究进入之前符合所有纳入和排除标准。在入学研究之前将获得书面知情同意书。符合资格标准的患者将以1：1的基础随机分配给CABG或使用Sirolimus洗脱支架的多人支架。该研究的主要结果是在5年期间，支架组和CABG组之间的死亡率差异。将评估以下次要终点：1）1、2、3和4年的生存功能； 2）30天，6个月零12个月的MACCE内院的个体组成部分； 3）每6个月前和后期化的生活质量，最多5年； 4）术前神经认知功能和6个月，1年和5年后的过程； 5）成本效益分析，住院时间，资源利用率，重复住院和重复血运重建事件。我们计划在100个临床部位的18个月内招募所有患者。