- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07634666
Prediction of Myocardial Injury After Non-Cardiac Surgery in Urologic Cancer Patients (URO-MINS)
Prediction of Myocardial Injury After Major Non-Cardiac Surgery in Patients With Urologic Cancer: A Prospective Multicenter Observational Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Myocardial injury after non-cardiac surgery (MINS) is associated with increased postoperative morbidity and mortality. Patients with urologic cancer undergoing major non-cardiac surgery may be at increased risk for perioperative cardiovascular complications. Early identification of patients at high risk for postoperative myocardial injury and adverse cardiovascular events may improve perioperative risk stratification and clinical management.
This prospective multicenter observational study aims to evaluate the predictive value of artificial intelligence-based analysis of preoperative 12-lead electrocardiography for postoperative myocardial injury after non-cardiac surgery (MINS) and major adverse cardiovascular events (MACE) within 30 days after surgery in patients undergoing non-cardiac surgery for urologic cancer.
Clinical characteristics, perioperative variables, electrocardiographic data, laboratory findings, and postoperative outcomes will be prospectively collected and analyzed to identify predictors of postoperative cardiovascular complications.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Dong Hyuck Cho, MD, PhD
- Phone Number: +82-2-920-5448
- Email: why012@gmail.com
Study Contact Backup
- Name: Jong-Chan Youn, MD, PhD
- Phone Number: +82-2-2258-6145
- Email: jong.chan.youn@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age ≥ 60 years
- Patients scheduled for major non-cardiac surgery under general anesthesia due to urologic cancer (e.g., radical prostatectomy, radical nephrectomy, partial nephrectomy)
- Patients who undergo preoperative standard 12-lead electrocardiography
- Patients classified as having intermediate or higher surgical risk
- Patients who can be followed for at least 30 days postoperatively
- Patients who voluntarily provide written informed consent to participate in this study
Exclusion Criteria:
- History of major adverse cardiovascular events (MACE) within 6 months prior to surgery
- Inability to obtain essential clinical information required for study participation and follow-up
- Patients who are not hospitalized after surgery
- Individuals deemed inappropriate for participation in the study by the investigator due to legal or psychiatric reasons
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Urologic cancer patients undergoing major non-cardiac surgery
Patients with urologic malignancy scheduled for major non-cardiac surgery will be prospectively enrolled and observed for perioperative myocardial injury and related outcomes.
|
This is a prospective observational study.
No interventions are administered.
Participants are followed for the development of myocardial injury after major non-cardiac surgery.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Myocardial Injury After Non-Cardiac Surgery (MINS)
Time Frame: Intraoperative day and postoperative days 1-2 (within 3 days after surgery)
|
Myocardial injury after non-cardiac surgery (MINS) defined as elevation of fourth-generation cardiac troponin T measured on the day of surgery, postoperative day 1, and postoperative day 2 (within 3 days after surgery).
|
Intraoperative day and postoperative days 1-2 (within 3 days after surgery)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
30-day Major Adverse Cardiovascular Events (MACE)
Time Frame: Within 30 days after surgery
|
Composite of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke occurring within 30 days after surgery.
|
Within 30 days after surgery
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Dong Hyuck Cho, MD, PhD, Korea University Anam Hospital
Publications and helpful links
General Publications
- Xie X, Hu W, Fan X, Chen H, Tang M. Interactions Between Phosphorus, Zinc, and Iron Homeostasis in Nonmycorrhizal and Mycorrhizal Plants. Front Plant Sci. 2019 Sep 26;10:1172. doi: 10.3389/fpls.2019.01172. eCollection 2019.
- Matsubara M, Muraki Y, Suzuki H, Hatano N, Muraki K. Critical amino acid residues regulating TRPA1 Zn2+ response: A comparative study across species. J Biol Chem. 2024 Jun;300(6):107302. doi: 10.1016/j.jbc.2024.107302. Epub 2024 Apr 18.
- Halvorsen S, Mehilli J, Cassese S, Hall TS, Abdelhamid M, Barbato E, De Hert S, de Laval I, Geisler T, Hinterbuchner L, Ibanez B, Lenarczyk R, Mansmann UR, McGreavy P, Mueller C, Muneretto C, Niessner A, Potpara TS, Ristic A, Sade LE, Schirmer H, Schupke S, Sillesen H, Skulstad H, Torracca L, Tutarel O, Van Der Meer P, Wojakowski W, Zacharowski K; ESC Scientific Document Group. 2022 ESC Guidelines on cardiovascular assessment and management of patients undergoing non-cardiac surgery. Eur Heart J. 2022 Oct 14;43(39):3826-3924. doi: 10.1093/eurheartj/ehac270. No abstract available.
- Zhong L, Yan K, Liu C, Xue J, Wu L, Yin F. Clinical reasoning: a young man with reversible paralysis, cerebral white matter lesions, and peripheral neuropathy. Neurology. 2012 Aug 21;79(8):e70-2. doi: 10.1212/WNL.0b013e3182661eca. No abstract available.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- URO-MINS-01
- 2026AN0157 (Other Identifier: Korea University Anam Hospital IRB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Urologic Cancer
-
University Hospital, GhentCompletedSurgery | Bladder Cancer | Urologic CancerBelgium
-
Duke UniversityNational Cancer Institute (NCI)Not yet recruitingPelvic Cancer | Urologic Cancer | Gynecologic Cancers | Vaginal Stenosis | Pelvic Radiotherapy | Anorectal CancerUnited States
-
Institute of Oncology LjubljanaRecruitingBreast Cancer | Gynecologic Cancer | Urologic CancerSlovenia
-
Memorial Sloan Kettering Cancer CenterNovartis PharmaceuticalsCompletedBladder Cancer | Ureter Cancer | Renal Pelvis CancerUnited States
-
GenomeDx Biosciences CorpVeracyte, Inc.Enrolling by invitationProstate Cancer | Bladder Cancer | Renal CancerUnited States
-
Dana-Farber Cancer InstituteCompletedKidney Cancer | Prostate Cancer | Genitourinary CancerUnited States
-
Relmada Therapeutics, Inc.WithdrawnUrothelial Carcinoma Bladder | Urologic Cancer | Urothelial Carcinoma Recurrent | Bladder (Urothelial, Transitional Cell) Cancer | Bladder (Urothelial, Transitional Cell) Cancer Superficial (Non-Invasive)
-
Academisch Medisch Centrum - Universiteit van Amsterdam...Bristol-Myers SquibbRecruitingUrinary Bladder Cancer | Invasive Bladder CancerNetherlands
-
Baylor College of MedicinePfizerTerminatedBladder Cancer | Invasive Bladder Cancer | Metastatic Bladder CancerUnited States
-
National Cancer Institute (NCI)CompletedStage III Bladder Cancer | Stage I Bladder Cancer | Stage II Bladder CancerUnited States
Clinical Trials on No intervention assigned
-
Chang Gung Memorial HospitalNot yet recruitingChronic Obstructive Pulmonary Disease (COPD)Taiwan
-
Kaohsiung Medical University Chung-Ho Memorial...CompletedHealthy Children and Their Main-care GiverTaiwan
-
Fondation IldysRecruitingCystic Fibrosis (CF) | Respiratory Infection Bacterial | Pulmonary ExacerbationFrance
-
Run-hua LiCompletedHELICOBACTER PYLORI INFECTIONSChina
-
Bursa City HospitalCompletedCOVID-19 | Rheumatic Diseases | AnxietyTurkey (Türkiye)
-
University of OxfordOxford University Hospitals NHS TrustNot yet recruitingFemoral Acetabular ImpingementUnited Kingdom
-
AspetarClinique du sportCompleted
-
German Cancer Research CenterCompletedMyocardial Infarction | Stroke | Cardiovascular MortalityGermany
-
Centre Hospitalier de CholetCompletedCoronary Disease | Acute Coronary SyndromeFrance