Clinical trial NCT06273735: Prospective Trial: Myocardial Injury After Noncardiac Surgery (MINS) Following Radical Prostatectomy
Official title: Evaluation of Intra- and Postoperative Cardiac Events in Patients With Localised Prostate Carcinoma and Radical Prostatectomy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Myocardial Injury
Keywords: MINS
Myocardial Injury after Noncardiac Surgery
radical prostatectomy
prostate cancer
complication
Clavien-Dindo
Myocardial infarction
Revised Cardiac Risk Index
Lead sponsor: Martini-Klinik am UKE GmbH
Sponsor class: OTHER
Collaborators: name: Universitätsklinikum Hamburg-Eppendorf
First posted: 2024-02-22
Enrollment: 1000
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with biopsy-proven prostate cancer who undergo open or robotic-assisted radical prostatectomy at the Martini Clinic are included (N=1000).

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: rate of MINS in standardised open and robot-assisted radical prostatectomy
timeFrame: the day before surgery until 24months follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Martini-Klinik am UKE GmbH
Study officials:
affiliation: Martini-Klinik am UKE GmbH
name: Markus Graefen, Prof.
role: STUDY_DIRECTOR
References:
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