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Not yet recruitingNCT06944301Updated Apr 25, 2025

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

An interventional study of blood sampling in MINS, Myocardial Injury After Noncardiac Surgery and Myocardial Injury After Noncardiac Surgery (MINS), sponsored by Medipol University. Not yet recruiting. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2025-04-25.

Sponsored by Medipol University · Not applicable, Interventional, and Screening

From the registry’s dates

  • Primary completion was expected by Jun 2026, 5 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
400
Allocation
Randomized
Ages
40 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • MINS
  • Myocardial Injury After Noncardiac Surgery
  • Myocardial Injury After Noncardiac Surgery (MINS)
  • Renal Calculi
  • Renal Stones
  • Percutaneous Nephrolithotomy (PNL)
  • Nephrolithiasis

Keywords

  • MINS
  • PNL
  • percutaneous nephrolithotomy
  • Myocardial Injury after Noncardiac Surgery
  • prone
  • supine
03

In context

Kidney Calculi

509 studies on the registry are indexed under Kidney Calculi; 146 are open to participants now.

This study's planned enrollment of 400 is above the median of 86 across 391 interventional studies indexed under Kidney Calculi.

Browse Kidney Calculi studies →

Lead sponsor

Medipol University is the lead sponsor of 326 studies on the registry; 88 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
400 participants (estimated)

Study arms

  • Other
    Supine PNL

    Patients undergoing PNL in the supine position.

    Diagnostic Test: blood sampling

  • Other
    Prone PNL

    Patients undergoing PNL in the prone position.

    Diagnostic Test: blood sampling

Interventions

  • Diagnostic testblood sampling

    measuring troponine preoperative and postoperative first and second day

06

What researchers measure

Primary outcomes

  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.

    Time frame: Up to 48 hours post-surgery

Secondary outcomes

  1. Surgical Duration

    Time from incision to closure (in minutes).

    Time frame: During surgery.

  2. Postoperative Hospital Stay

    Duration of hospital stay after surgery (in days).

    Time frame: From surgery to discharge.

07

Study locations

No study locations are listed for this record.

08

References and documents

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 ↗

Individual participant data

Plan to share: No — Individual participant data will not be shared to protect patient privacy. Aggregated data may be published in scientific journals.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06944301
Lead sponsor
Medipol University
Responsible party
Ali Ihsan Memmi (medical doctor, Medipol University) — Principal investigator
First posted
Apr 25, 2025
Start date
Jun 1, 2025 (estimated)
Primary completion
Jun 1, 2026 (estimated)
Completion
Aug 1, 2026 (estimated)
Last update
Apr 25, 2025

Study contacts

Ali İhsan Memmi, Medical Doctor
Contact
alimemmi@gmail.com
+90 537 9220997

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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