Myocard Injury After Non Cardiac SurgeryNCT06502340
PERIOPERATIVE MYOCARDIAL DAMAGE IN ROBOT-ASSISTED SURGERY
An observational study of Myocard Injury After Non Cardiac Surgery and Robotic Assisted Laparoscopic Radical Prostatectomy, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
Our study aimed to identify myocardial damage during or after robotic-assisted radical prostatectomy by measuring high-sensitive Troponin I levels, which are the most sensitive and effective according to the AHA/ACC guideline. Read more about this study
- Who is it for?
- Any age, men onlyHealthy volunteers can take part
- Conditions the study is for
- Myocard Injury After Non Cardiac Surgery, Robotic Assisted Laparoscopic Radical Prostatectomy
- What is being tested?
- high sensitive troponin I
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Jul 2024to 30 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All patients undergoing elective robotic-assisted laparoscopic radical prostatectomy will be included in the study.
Who may be able to join
- Patients who will undergo elective robotic surgery
- Patients with I, II, and III according to ASA classification
- Those with body mass index (BMI) below 35kg/m2
- Patients whose consent was obtained before the procedure
Who cannot join
- Patients who were converted to open surgery for any reason
- patients who did not agree to participate in the research
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ASSESSMENT OF PERIOPERATIVE MYOCARDIAL DAMAGE IN ROBOT-ASSISTED LAPAROSCOPIC RADICAL PROSTATECTOMIES
Our study aimed to identify myocardial damage during or after robotic-assisted radical prostatectomy by measuring high-sensitive Troponin I levels, which are the most sensitive and effective according to the AHA/ACC guideline. The study\'s secondary objective was to establish which parameters were associated with myocardial damage.
- Conditions
- Myocard Injury After Non Cardiac Surgery, Robotic Assisted Laparoscopic Radical Prostatectomy
- Being tested
- high sensitive troponin I
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high sensitive troponin IDiagnostic test
high-sensitive Troponin I levels
| Study group | Role | What they receive |
|---|---|---|
| patient | All patients who will undergo elective robotic-assisted laparoscopic radical prostatectomy Receives: Diagnostic Test: high sensitive troponin I |
What is being measured
The primary outcome is the main question the study is designed to answer.
high-sensitive Troponin I levels
Measured: preoperative
high-sensitive Troponin I levels
Measured: postoperative 24th hour
high-sensitive Troponin I levels
Measured: postoperative 48th hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start17 Jul 2024
- Primary completion1 Sep 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocard Injury After Non Cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Betül Güven, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06502340
- Sponsor's protocol ID
- E2-23-5211
- Status last verified
- Jul 2024
- First submitted
- 9 Jul 2024
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ASSESSMENT OF PERIOPERATIVE MYOCARDIAL DAMAGE IN ROBOT-ASSISTED LAPAROSCOPIC RADICAL PROSTATECTOMIES
- ClinicalTrials.gov ID
- NCT06502340
- Acronym / sponsor ID
- E2-23-5211
- Conditions
- Myocard Injury After Non Cardiac Surgery, Robotic Assisted Laparoscopic Radical Prostatectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 17 Jul 2024 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 16 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Our study aimed to identify myocardial damage during or after robotic-assisted radical prostatectomy by measuring high-sensitive Troponin I levels, which are the most sensitive and effective according to the AHA/ACC guideline. The study\'s secondary objective was to establish which parameters were associated with myocardial damage.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patient | – | Diagnostic Test: high sensitive troponin IAll patients who will undergo elective robotic-assisted laparoscopic radical prostatectomy |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients undergoing elective robotic-assisted laparoscopic radical prostatectomy will be included in the study.
Key inclusion criteria (4 listed)
- Patients who will undergo elective robotic surgery
- Patients with I, II, and III according to ASA classification
- Those with body mass index (BMI) below 35kg/m2
- Patients whose consent was obtained before the procedure
Key exclusion criteria (2 listed)
- Patients who were converted to open surgery for any reason
- patients who did not agree to participate in the research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| high sensitive troponin Ihigh-sensitive Troponin I levels | Diagnostic test | patient |
Primary outcome
high-sensitive Troponin I levels
Time frame: preoperative
high-sensitive Troponin I levels
Time frame: postoperative 24th hour
high-sensitive Troponin I levels
Time frame: postoperative 48th hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: Undecided
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MYOCARD INFARCTUS, Non Cardiac Surgery
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocard Injury After Non Cardiac Surgery and Robotic Assisted Laparoscopic Radical Prostatectomy, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
high-sensitive Troponin I levels (time frame: preoperative). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.