Creating a tool to assess heart injury risk after orthopedic surgery
Development of a New Prognostic Assessment Tool for Postoperative Myocardial Injury : the TROPUTILE Score. A Non-interventional Prospective Study
This study is trying to create a tool to help doctors find out which patients over 50 are at risk for heart injury after orthopedic surgeries like hip or knee operations.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1600 (estimated) |
| Ages | 50 Years to 100 Years |
| Sex | All |
| Sponsor | University Hospital, Brest Academic / other |
| Locations | 2 sites (Brest and 1 other locations) |
| Trial ID | NCT04286685 on ClinicalTrials.gov |
What this trial studies
This observational cohort study focuses on patients over 50 years old undergoing orthopedic surgeries such as hip, knee, or spine operations. It aims to determine the incidence of myocardial injury after noncardiac surgery (MINS) and identify perioperative factors that contribute to its occurrence. By analyzing troponin levels and surgical Apgar scores, the study seeks to develop a prognostic assessment tool to better identify patients at risk for MINS and poor outcomes.
Who should consider this trial
Good fit: Ideal candidates are patients over 50 years old scheduled for orthopedic surgery.
Not a fit: Patients with conditions such as sepsis, acute coronary syndrome, or pulmonary embolism may not benefit from this study.
Why it matters
Potential benefit: If successful, this tool could help healthcare providers identify at-risk patients and improve postoperative care, potentially reducing morbidity and mortality.
How similar studies have performed: Other studies have shown success in using troponin levels and surgical scores to predict postoperative outcomes, indicating that this approach has a foundation in existing research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * \> 50 years * orthopedic surgery (hip, knee, spine) * written consent Exclusion Criteria: * no troponin measurement prior surgery * sepsis * acute coronary syndrome * pulmonary embolism * refusing to participate * guardianship
Where this trial is running
Brest and 1 other locations
- CHRU Brest — Brest, France (Recruiting)
- CHU Rennes — Rennes, France (Recruiting)
Study contacts
- Principal investigator: Olivier HUET, MD, PhD — CHRU Brest
- Study coordinator: Olivier HUET, MD,PhD
- Email: olivier.huet@chu-brest.fr
- Phone: +33298347288
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.