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MINSNCT06944301

Comparison of Myocardial Injury After Noncardiac Surgery (MINS) Incidence in Supine vs. Prone Positioning During Percutaneous Nephrolithotomy (PNL)

A study testing blood sampling in people with MINS and Myocardial Injury After Noncardiac Surgery, run by Medipol University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This prospective cohort study aims to compare the incidence of Myocardial Injury after Noncardiac Surgery (MINS) in patients undergoing percutaneous nephrolithotomy (PNL) for kidney stones in supine versus prone positioning. Read more about this study

Who is it for?
Ages 40 years and older
What is being tested?
blood sampling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
No sites listed yet
Study dates
1 Jun 2025to 1 Aug 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥40 years.
  • Patients undergoing percutaneous nephrolithotomy (PNL) for kidney stones.
  • Willing and able to provide informed consent.

Who cannot join

  • Known coronary artery disease, heart failure, or other significant cardiovascular conditions.
  • Elevated preoperative troponin levels (≥0.03 ng/mL).
  • Major intraoperative complications (e.g., severe bleeding requiring transfusion).
  • Inability to comply with study procedures.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Ali İhsan Memmi, Medical Doctor contact

+90 537 9220997

alimemmi@gmail.com

About this study

This prospective cohort study aims to compare the incidence of Myocardial Injury after Noncardiac Surgery (MINS) in patients undergoing percutaneous nephrolithotomy (PNL) for kidney stones in supine versus prone positioning. MINS is defined as an elevated postoperative troponin level (≥0.03 ng/mL) within 48 hours after surgery. Approximately 400 patients will be enrolled, with 200 patients in each positioning group (supine and prone). The primary outcome is the incidence of MINS, assessed through troponin measurements and electrocardiogram (ECG) findings. Secondary outcomes include intraoperative complications, duration of surgery, and postoperative recovery metrics. The study seeks to determine whether surgical positioning impacts MINS risk, potentially guiding safer surgical practices.

Read the detailed description

Myocardial Injury after Noncardiac Surgery (MINS) is a significant perioperative complication associated with increased morbidity and mortality. This study investigates whether surgical positioning (supine vs. prone) during percutaneous nephrolithotomy (PNL) influences the incidence of MINS. Patients aged 18 years and older undergoing PNL for kidney stones will be enrolled in a prospective cohort study at [Institution Name]. Exclusion criteria include pre-existing cardiovascular disease, elevated baseline troponin levels, or major intraoperative complications. Approximately 400 patients will be divided into two groups based on surgical positioning: 200 in the supine group and 200 in the prone group. Troponin levels will be measured preoperatively and at 24 and 48 hours postoperatively, with MINS defined as a troponin T level ≥0.03 ng/mL. Electrocardiograms (ECGs) will be performed to detect ischemic changes. Secondary outcomes include intraoperative hypotension, surgical duration, and postoperative hospital stay. Data will be analyzed using chi-square tests and logistic regression to adjust for confounders such as age, comorbidities, and surgical duration. The study aims to provide evidence on the impact of positioning on MINS, potentially informing safer surgical protocols for PNL.

Being tested
blood sampling
Keywords
MINS, PNL, percutaneous nephrolithotomy, Myocardial Injury after Noncardiac Surgery, prone, supine
Medical subject headings
Kidney Calculi, Nephrolithiasis, Deception

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • blood samplingDiagnostic test

    measuring troponine preoperative and postoperative first and second day

Study groups in NCT06944301
Study groupRoleWhat they receive
Supine PNLOtherPatients undergoing PNL in the supine position.
Receives: Diagnostic Test: blood sampling
Prone PNLOtherPatients undergoing PNL in the prone position.
Receives: Diagnostic Test: blood sampling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Myocardial Injury after Noncardiac Surgery (MINS)

    Proportion of patients with postoperative troponin T levels ≥0.03 ng/mL within 48 hours after PNL, confirmed by ECG findings if ischemic changes are present.

    Measured: Up to 48 hours post-surgery

Secondary outcomes (2)

  1. Surgical Duration

    Time from incision to closure (in minutes).

    Measured: During surgery.

  2. Postoperative Hospital Stay

    Duration of hospital stay after surgery (in days).

    Measured: From surgery to discharge.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2025
  2. Study start1 Jun 2025 (estimated)
  3. Primary completion1 Jun 2026 (estimated)
  4. Study completion1 Aug 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06944301
Sponsor's protocol ID
3211789
Status last verified
Apr 2025
First submitted
15 Apr 2025
Last updated
25 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared to protect patient privacy. Aggregated data may be published in scientific journals.

Publications

  • Saha S, Dua A. Stochastic Lindemann kinetics for unimolecular gas-phase reactions. J Phys Chem A. 2013 Aug 22;117(33):7661-9. doi: 10.1021/jp402675s. Epub 2013 Aug 13.

    PubMed 23879409

  • Li L, Quang TS, Gracely EJ, Kim JH, Emrich JG, Yaeger TE, Jenrette JM, Cohen SC, Black P, Brady LW. A Phase II study of anti-epidermal growth factor receptor radioimmunotherapy in the treatment of glioblastoma multiforme. J Neurosurg. 2010 Aug;113(2):192-8. doi: 10.3171/2010.2.JNS091211.

    PubMed 20345222

  • Preston GC, Keene ON, Palmer JL. The effect of ondansetron on the pharmacokinetics and pharmacodynamics of temazepam. Anaesthesia. 1996 Sep;51(9):827-30. doi: 10.1111/j.1365-2044.1996.tb12610.x.

    PubMed 8882243

  • Edward GM, Das SF, Elkhuizen SG, Bakker PJ, Hontelez JA, Hollmann MW, Preckel B, Lemaire LC. Simulation to analyse planning difficulties at the preoperative assessment clinic. Br J Anaesth. 2008 Feb;100(2):195-202. doi: 10.1093/bja/aem366.

    PubMed 18211993

  • POISE Study Group; Devereaux PJ, Yang H, Yusuf S, Guyatt G, Leslie K, Villar JC, Xavier D, Chrolavicius S, Greenspan L, Pogue J, Pais P, Liu L, Xu S, Malaga G, Avezum A, Chan M, Montori VM, Jacka M, Choi P. Effects of extended-release metoprolol succinate in patients undergoing non-cardiac surgery (POISE trial): a randomised controlled trial. Lancet. 2008 May 31;371(9627):1839-47. doi: 10.1016/S0140-6736(08)60601-7. Epub 2008 May 12.

    PubMed 18479744

  • Chretien AE, Gagnon-Arsenault I, Dube AK, Barbeau X, Despres PC, Lamothe C, Dion-Cote AM, Lague P, Landry CR. Extended Linkers Improve the Detection of Protein-protein Interactions (PPIs) by Dihydrofolate Reductase Protein-fragment Complementation Assay (DHFR PCA) in Living Cells. Mol Cell Proteomics. 2018 Feb;17(2):373-383. doi: 10.1074/mcp.TIR117.000385. Epub 2017 Dec 4.

    PubMed 29203496

  • Writing Committee for the VISION Study Investigators; Devereaux PJ, Biccard BM, Sigamani A, Xavier D, Chan MTV, Srinathan SK, Walsh M, Abraham V, Pearse R, Wang CY, Sessler DI, Kurz A, Szczeklik W, Berwanger O, Villar JC, Malaga G, Garg AX, Chow CK, Ackland G, Patel A, Borges FK, Belley-Cote EP, Duceppe E, Spence J, Tandon V, Williams C, Sapsford RJ, Polanczyk CA, Tiboni M, Alonso-Coello P, Faruqui A, Heels-Ansdell D, Lamy A, Whitlock R, LeManach Y, Roshanov PS, McGillion M, Kavsak P, McQueen MJ, Thabane L, Rodseth RN, Buse GAL, Bhandari M, Garutti I, Jacka MJ, Schunemann HJ, Cortes OL, Coriat P, Dvirnik N, Botto F, Pettit S, Jaffe AS, Guyatt GH. Association of Postoperative High-Sensitivity Troponin Levels With Myocardial Injury and 30-Day Mortality Among Patients Undergoing Noncardiac Surgery. JAMA. 2017 Apr 25;317(16):1642-1651. doi: 10.1001/jama.2017.4360.

    PubMed 28444280

Questions about this trial

What is this clinical trial studying?

A study testing blood sampling in people with MINS and Myocardial Injury After Noncardiac Surgery, run by Medipol University.

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 3 inclusion and 4 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: opening soon, as of the sponsor's last update on 25 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ali İhsan Memmi, Medical Doctor (+90 537 9220997, alimemmi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Myocardial Injury after Noncardiac Surgery (MINS) (time frame: Up to 48 hours post-surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06944301, which also lists 7 linked publications.

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 25 Apr 2025.

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