Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Heart and Blood Diseases

Symptoms and General Pathology

Wounds and Injuries

Carcinoma

Prostatic Neoplasms

Myocardial Infarction

Infarction

The cohort consists of open and robotic-assisted radical prostatectomy patients. The rate of MINS 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.

An intervention is carried out as part of the normal clinical procedure regardless of the study measurement parameters.

Pre- and postoperative determination of troponin as part of the study and 24-month FU survey

Randi M. Pose, MD

Anke Renter

Markus Graefen, Professor

Markus Graefen, Prof.

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.

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.

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

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

A publication in a peer-reviewed journal is planned.

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Prospective Trial: Myocardial Injury After Noncardiac Surgery (MINS) Following Radical Prostatectomy	NCT06273735	Myocardial Inju...	Pre- and postop...	18 Years -	Martini-Klinik am UKE GmbH
Prospective Trial: Myocardial Injury After Noncardiac Surgery (MINS) Following Radical Prostatectomy	NCT06273735	Myocardial Inju...	Pre- and postop...	18 Years -	Martini-Klinik am UKE GmbH

Spots Global Cancer Trial Database for revised cardiac risk index