Risk Stratification of MACE Based on GDF-15 in Heart Failure Patients Who Undergoing Coronary Artery Bypass Grafting: an Observational Multicenter Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Time to first adverse cardiovascular event (months)
研究概览
简要总结
PROFILE-HF is a multicenter, observational, prospective study of the clinical course and outcomes of chronic heart failure (HF) and coronary artery disease (CAD) in patients undergoing coronary artery bypass grafting (CABG).
The objective of the study is to develop a method for assessing the risk of adverse cardiovascular events in patients with CAD and HF who have undergone CABG, based on preoperative GDF-15 concentrations.
The study will have a 12-month follow-up period; one in-person visit is planned at the end of the follow-up period. If it is not possible to visit a doctor in person, information will be collected through telephone contact with the patient or his relative or person caring for the patient.
详细描述
PROFILE-HF is a multicenter, observational, prospective study of the clinical course and outcomes of chronic heart failure (HF) and coronary artery disease (CAD) in patients undergoing coronary artery bypass grafting (CABG).
The objective of the study is to develop a method for assessing the risk of adverse cardiovascular events in patients with CAD and HF who have undergone CABG, based on preoperative GDF-15 concentrations.
The study will include patients with a documented diagnosis of CHF and CAD who are recommended for coronary artery bypass grafting by the cardiac team.
The study will collect and record patient examination and treatment data, which will be conducted in accordance with established standards of care for patients with CAD and will not be part of the study.
The study will also analyze GDF-15. At each study center, upon patient enrollment, after signing informed consent, blood will be collected from the cubital vein in the morning before CABG. The blood will be collected in a vacuum tube containing 8 ml of clot activator (red-topped vacutainer) containing clot activator. Further preparation of the blood samples for analysis will include centrifugation for 10 minutes at 2,500 rpm, separation of the serum using a pipette into three 500 μg Eppendorf tubes, and freezing at -20°C. Serum samples will be transported by a specialized cold chain company. Analysis will be performed after a single thaw of the serum/plasma in the laboratory of the Cardiology Research Institute of Tomsk National Research Medical Center.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Heart Failure
- •Planned coronary artery bypass grafting
排除标准
- •Myocardial infarction
- •Presence of implanted devices;
- •Need for additional cardiac surgery other than coronary artery bypass grafting (valve repair, aneurysm);
- •Severe renal dysfunction (GFR <30 ml/min/1.73 m2);
- •Severe comorbidities: active cancer; infiltrative cardiac diseases (sarcoidosis, amyloidosis, storage diseases); autoimmune diseases; acute infectious diseases and exacerbations of chronic somatic diseases.
结局指标
主要结局
Time to first adverse cardiovascular event (months)
时间窗: From enrollment to the end of treatment at 12 months
Time to first adverse cardiovascular event, including cardiovascular (CV) death or nonfatal myocardial infarction (MI) and/or nonfatal stroke and/or unplanned revascularization and/or heart failure (HF) hospitalization and/or worsening of heart failure (worsening by at least one NYHA class requiring increased intensity of diuretic therapy).
次要结局
- Deaths from cardiovascular causes (percentage)(From enrollment to the end of treatment at 12 months)
- All-cause mortality(From enrollment to the end of treatment at 12 months)
- HF hospitalization (percentage)(From enrollment to the end of treatment at 12 months)
- Acute ischemic events (percentage)(From enrollment to the end of treatment at 12 months)
- Secondary composite endpoint (percentage)(From enrollment to the end of treatment at 12 months)
研究者
Elena A. Kuzheleva
Researcher
Tomsk National Research Medical Center of the Russian Academy of Sciences