Prospective Trial: Acute Myocardial Injury After Radical Prostatectomy

Martini-Klinik am UKE GmbH

Status: Completed

Conditions: Myocardial Injury

Treatments: Diagnostic Test: Pre- and postoperative determination of troponin as part of the study and 24-month FU survey

Study type: Observational

Funder types: Other

Identifiers

NCT06273735

PV7350 (Other Identifier)

2019-PS-33b

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

1,000 participants in 1 patient group

radical prostatectomy patients with versus without acute myocardial injury

Description:

The cohort consists of open and robotic-assisted radical prostatectomy patients. The rate of acute myocardial injury 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.

Treatment:

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