JOURNAL ONKOLOGIE – STUDIE

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

Studien-Informationen Einschlusskriterien Studien-Rationale Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT06273735

Studienbeginn:
August 2023

Letztes Update:
22.02.2024

Wirkstoff:
-

Indikation (Clinical Trials):
Wounds and Injuries

Geschlecht:
Männer

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Martini-Klinik am UKE GmbH

Collaborator:
Universitätsklinikum Hamburg-Eppendorf

Studienleiter

Markus Graefen, Prof.
Study Director
Martini-Klinik am UKE GmbH

Kontakt

Randi M. Pose, MD
Kontakt:
Phone: +4915222827204
E-Mail: r.pose@uke.de» Kontaktdaten anzeigen

Anke Renter
Kontakt:
Phone: +49407410533115
E-Mail: a.renter@uke.de» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

Martini-Klinik am UKE GmbH
20246 Hamburg
(Hamburg)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Markus Graefen, Professor
Phone: +4904741051300
E-Mail: graefen@uke.de

Anke Renter
Phone: +49407410533115
E-Mail: renter@uke.de» Ansprechpartner anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. rate of MINS in standardised open and robot-assisted radical prostatectomy (Time Frame - 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.

Geprüfte Regime

Pre- 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.

Quelle: ClinicalTrials.gov

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