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

Recruiting

• Conditions: Myocardial Injury
• Interventions: Diagnostic Test: Pre- and postoperative determination of troponin as part of the study and 24-month FU survey

• Registration Number: NCT06273735
• Lead Sponsor: Martini-Klinik am UKE GmbH

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.

Study Timeline

• Study Start: 2023-08-14
• Status Verified: 2024-02
• Study First Submitted: 2024-02-15
• Study First Submitted QC: 2024-02-15
• Last Update Submitted: 2024-02-15
• Study First Posted: 2024-02-22
• Last Update Posted: 2024-02-22
• Primary Completion: 2024-03
• Study Completion: 2026-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
radical prostatectomy patients with versus without MINS	Pre- and postoperative determination of troponin as part of the study and 24-month FU survey	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.

Primary Outcome Measures

Name	Time	Method
rate of MINS 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.

Trial Locations

Locations (1)

Martini-Klinik am UKE GmbH; 🇩🇪 Hamburg, Germany