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Trial Title:
Prospective Trial: Myocardial Injury After Noncardiac Surgery (MINS) Following Radical Prostatectomy
NCT ID:
NCT06273735
Condition:
Myocardial Injury
Conditions: Official terms:
Wounds and Injuries
Conditions: Keywords:
MINS
Myocardial Injury after Noncardiac Surgery
radical prostatectomy
prostate cancer
complication
Clavien-Dindo
Myocardial infarction
Revised Cardiac Risk Index
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Pre- and postoperative determination of troponin as part of the study and 24-month FU survey
Description:
An intervention is carried out as part of the normal clinical procedure regardless of the
study measurement parameters.
Arm group label:
radical prostatectomy patients with versus without MINS
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.
Criteria for eligibility:
Study pop:
Patients with biopsy-proven prostate cancer who undergo open or robotic-assisted radical
prostatectomy at the Martini Clinic are included (N=1000).
Sampling method:
Probability Sample
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
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Martini-Klinik am UKE GmbH
Address:
City:
Hamburg
Zip:
20246
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Markus Graefen, Professor
Phone:
+4904741051300
Email:
graefen@uke.de
Contact backup:
Last name:
Anke Renter
Phone:
+49407410533115
Email:
renter@uke.de
Start date:
August 14, 2023
Completion date:
October 2026
Lead sponsor:
Agency:
Martini-Klinik am UKE GmbH
Agency class:
Other
Collaborator:
Agency:
Universitätsklinikum Hamburg-Eppendorf
Agency class:
Other
Source:
Martini-Klinik am UKE GmbH
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06273735
