Myocardial Injury
Conditions
Keywords
acute myocardial injury, Myocardial Injury after Noncardiac Surgery, radical prostatectomy, prostate cancer, complication, Clavien-Dindo, Myocardial infarction, Revised Cardiac Risk Index
Brief summary
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.
Detailed description
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: 1. recording the frequency of acute myocardial damage without or with clinical findings typical of ischaemia. 2. 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. 3. correlation between the level of postoperative troponin increase and the occurrence of cardiovascular events during hospitalisation. 4. predictive value of the Revised Cardiac Risk Index for the occurrence of acute myocardial damage. 5. 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.
Interventions
An intervention is carried out as part of the normal clinical procedure regardless of the study measurement parameters.
Sponsors
Study design
Eligibility
Inclusion criteria
* Consent form signed * Patients with a biopsy-proven prostate carcinoma * planned ORP or RARP
Exclusion criteria
* No exclusion of patients who fulfil the above inclusion criteria
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| rate of acute myocardial injury in standardised open and robot-assisted radical prostatectomy | 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. |
Countries
Germany
Contacts
Martini-Klinik am UKE GmbH