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Prospective Trial: Acute Myocardial Injury After Radical Prostatectomy

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06273735
Enrollment
1000
Registered
2024-02-22
Start date
2023-08-14
Completion date
2025-08-26
Last updated
2026-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Injury

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

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

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

Sponsors

Martini-Klinik am UKE GmbH
Lead SponsorOTHER
Universitätsklinikum Hamburg-Eppendorf
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

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

MeasureTime frameDescription
rate of acute myocardial injury in standardised open and robot-assisted radical prostatectomythe day before surgery until 24months follow-upSurvey 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

STUDY_DIRECTORMarkus Graefen, Prof.

Martini-Klinik am UKE GmbH

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026