Evaluation of Intra- and Postoperative Cardiac Events in Patients With Localised Prostate Carcinoma and Radical Prostatectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- rate of acute myocardial injury in standardised open and robot-assisted radical prostatectomy
研究概览
简要总结
This prospective observational study investigates the incidence of acute myocardial injury after radical prostatectomy for prostate cancer. Consecutive patients undergoing elective open or robot-assisted radical prostatectomy at the Martini-Klinik are included. High-sensitivity cardiac troponin I (hs-cTnI) is measured preoperatively and on postoperative days 1 and 2 to identify acute myocardial injury, defined according to the 4th Universal Definition of Myocardial Infarction. Secondary outcomes include the incidence of myocardial infarction, major adverse cardiac and cerebrovascular events, and mortality during the hospital stay and at 24 months. Baseline patient characteristics (age, BMI, cardiovascular risk factors including the Revised Cardiac Risk Index, comorbidities, and prior cardiac therapy) as well as surgical and tumor-specific parameters are recorded. Associations between acute myocardial injury and clinical variables are analyzed.
详细描述
Primary endpoint:
Acute myocardial injury, defined as a postoperative troponin concentration above the 99th percentile sex-specific upper reference limit with a) an increase of ≥ 50% from baseline if the baseline troponin I or T concentration was below the 99th percentile sex-specific upper reference limit or with b) an increase of ≥ 20% from baseline if the baseline troponin I or T concentration was above the 99th percentile sex-specific upper reference limit. percentile or with b) an increase of ≥ 20 % compared to the initial value if the initial troponin I or T concentration was above the sex-specific upper reference limit of the 99th percentile.
Secondary endpoints:
- recording the frequency of acute myocardial damage without or with clinical findings typical of ischaemia.
- frequency of cardiovascular events during hospitalisation. Cardiovascular events are defined as follows: non-fatal cardiac arrest, heart failure, interventional coronary angiography, coronary artery bypass surgery, new-onset atrial fibrillation, stroke, pulmonary artery embolism, deep vein thrombosis of leg or arm.
- correlation between the level of postoperative troponin increase and the occurrence of cardiovascular events during hospitalisation.
- predictive value of the Revised Cardiac Risk Index for the occurrence of acute myocardial damage.
- differences in the incidence of acute myocardial damage in open radical prostatectomies versus minimally invasive radical prostatectomies.
Furthermore, the included patients are followed up for 24 months and questioned about cardiovascular events.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Consent form signed
- •Patients with a biopsy-proven prostate carcinoma
- •planned ORP or RARP
排除标准
- •No exclusion of patients who fulfil the above inclusion criteria
研究组 & 干预措施
radical prostatectomy patients with versus without acute myocardial injury
The cohort consists of open and robotic-assisted radical prostatectomy patients. The rate of acute myocardial injury is determined by laboratory chemistry as part of the study as well as clinically through routine visits and postoperatively through questionnaires. Intervention is not performed according to the study protocol but is part of the normal clinical course, if necessary.
干预措施: Pre- and postoperative determination of troponin as part of the study and 24-month FU survey (Diagnostic Test)
结局指标
主要结局
rate of acute myocardial injury in standardised open and robot-assisted radical prostatectomy
时间窗: the day before surgery until 24months follow-up
Survey of the rate of asymptomatic and symptomatic myocardial damage. A troponin determination is carried out before the prostatectomy as well as a troponin determination on the first and second postoperative day. An ACS is recorded clinically. Myocardial events and treatment of myocardial infarction are also recorded during the follow-up.
次要结局
未报告次要终点