NCT07634666

Brief Summary

This prospective multicenter observational study aims to evaluate the predictive value of artificial intelligence-based analysis of preoperative 12-lead electrocardiography for 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
29mo left

Started Jul 2026

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress2%
Jul 2026Dec 2028

First Submitted

Initial submission to the registry

June 3, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 9, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

July 15, 2026

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

July 22, 2026

Status Verified

July 1, 2026

Enrollment Period

2.5 years

First QC Date

June 3, 2026

Last Update Submit

July 20, 2026

Conditions

Keywords

Artificial IntelligenceElectrocardiographyMyocardial Injury After Non-cardiac SurgeryMajor Adverse Cardiovascular EventsPerioperative Cardiovascular RiskUrologic Cancer

Outcome Measures

Primary Outcomes (1)

  • Number of Participants with Myocardial Injury After Non-Cardiac Surgery (MINS)

    Myocardial injury after non-cardiac surgery (MINS), defined as an 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 Outcomes (1)

  • Number of Participants with 30-Day Major Adverse Cardiovascular Events (MACE)

    Within 30 days after surgery

Study Arms (1)

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.

Other: No intervention assigned

Interventions

This is a prospective observational study. No interventions are administered. Participants are followed for the development of myocardial injury after major non-cardiac surgery.

Urologic cancer patients undergoing major non-cardiac surgery

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients aged 60 years or older scheduled for major non-cardiac surgery under general anesthesia due to urologic malignancy (e.g., radical prostatectomy, radical nephrectomy, partial nephrectomy) will be prospectively enrolled from participating centers. All eligible patients who provide informed consent and meet inclusion criteria will be followed for perioperative myocardial injury and 30-day cardiovascular outcomes.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul St. Mary's Hospital, The Catholic University of Korea

Seoul, 06591, South Korea

RECRUITING

Related Publications (4)

  • 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.

MeSH Terms

Conditions

Urologic Neoplasms

Condition Hierarchy (Ancestors)

Urogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesUrologic Diseases

Study Officials

  • Dong Hyuck Cho, MD, PhD

    Korea University Anam Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dong Hyuck Cho, MD, PhD

CONTACT

Jong-Chan Youn, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 3, 2026

First Posted

June 9, 2026

Study Start

July 15, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

July 22, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared due to privacy concerns and institutional policies governing clinical data protection.

Locations