Prospective Trial: Myocardial Injury After Noncardiac Surgery (MINS) Following Radical Prostatectomy

Myocardial Injury Clinical Trial

Official title: Evaluation of Intra- and Postoperative Cardiac Events in Patients With Localised Prostate Carcinoma and Radical Prostatectomy

Status Recruiting

Clinical Trial Summary

The aim of this study is to prospectively analyse the rate of MINS in the standardised radical prostatectomy patient clientele at the Martini-Clinic and to identify risk factors. Pre- and postoperative troponin levels are determined (1st and 2nd postoperative day). The patient's height, weight, age and cardiovascular risk factors (including determination of the Revised Cardiac Risk Index) are recorded in the medical history as well as previous medical and interventional cardiological therapy. Furthermore, the prostate carcinoma-associated tumour and surgical parameters are determined. Clinically significant cardiovascular events during the inpatient stay are also described. Finally, a description of the rate of events, a check for correlation with the Revised Cardiac Risk Index and an identification of risk factors are carried out.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Myocardial Injury
• Wounds and Injuries

• NCT number: NCT06273735
• Study type: Observational
• Source: Martini-Klinik am UKE GmbH
• Contact: Randi M. Pose, MD
• Phone: +4915222827204
• Email: r.pose@uke.de
• Status: Recruiting
• Start date: August 14, 2023
• Completion date: October 2026