Prediction of Myocardial Injury After Non-Cardiac Surgery in Urologic Cancer Patients (URO-MINS)
20. juli 2026 oppdatert av: Cho, Dong Hyuck, Korea University Anam Hospital
Prediction of Myocardial Injury After Major Non-Cardiac Surgery in Patients With Urologic Cancer: A Prospective Multicenter Observational Study
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.
Studieoversikt
Status
Rekruttering
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Observasjonsmessig
Registrering (Antatt)
200
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Dong Hyuck Cho, MD, PhD
- Telefonnummer: +82-2-920-5448
- E-post: why012@gmail.com
Studer Kontakt Backup
- Navn: Jong-Chan Youn, MD, PhD
- Telefonnummer: +82-2-2258-6145
- E-post: jong.chan.youn@gmail.com
Studiesteder
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Seoul, Sør -Korea, 06591
- Rekruttering
- Seoul St. Mary's Hospital, The Catholic University of Korea
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Ta kontakt med:
- Maljoung Ahn
- Telefonnummer: +82-2-3147-9853
- E-post: cmccasc@gmail.com
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
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.
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
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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.
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This is a prospective observational study.
No interventions are administered.
Participants are followed for the development of myocardial injury after major non-cardiac surgery.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Number of Participants with Myocardial Injury After Non-Cardiac Surgery (MINS)
Tidsramme: Intraoperative day and postoperative days 1-2 (within 3 days after surgery)
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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)
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Intraoperative day and postoperative days 1-2 (within 3 days after surgery)
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Number of Participants with 30-Day Major Adverse Cardiovascular Events (MACE)
Tidsramme: Within 30 days after surgery
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Composite of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke occurring within 30 days after surgery.
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Within 30 days after surgery
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Dong Hyuck Cho, MD, PhD, Korea University Anam Hospital
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
15. juli 2026
Primær fullføring (Antatt)
31. desember 2028
Studiet fullført (Antatt)
31. desember 2028
Datoer for studieregistrering
Først innsendt
3. juni 2026
Først innsendt som oppfylte QC-kriteriene
3. juni 2026
Først lagt ut (Faktiske)
9. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
22. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
20. juli 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- URO-MINS-01
- 2026AN0157 (Annen identifikator: Korea University Anam Hospital IRB)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
Individual participant data will not be shared due to privacy concerns and institutional policies governing clinical data protection.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .