Evaluation of the Incidence of Myocardial Damage Following Upper and Lower Gastrointestinal Endoscopy in High-risk Patients

NCT07179549 | Not Yet Recruiting

• 1 other identifier: MINS-Endoscopy Study
• Study Type: observational
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

Hypoperfusion occurs following anaesthesia induction as a result of:

1. 1.a reduction in venous return and cardiac output subsequent to the dilatation of the venous reservoir, and
2. 2.a reduction in mean arterial pressure (MAP) secondary to arteriolar vasodilatation (reduction in arterial resistance) and decreased cardiac output. Many studies in the literature have focused on intraoperative hypotension and have reported an association between intensity x duration of hypotension and the occurrence of postoperative adverse events. Smaller interventional studies have suggested that improving stroke volume (SV, and therefore cardiac output) using fluid titration could reduce postoperative complications. Among postoperative adverse events consecutive to hypoperfusion, the occurrence of myocardial injury after noncardiac surgery (MINS) is well documented and is correlated to postoperative mortality at day 30.

Conditions

GI Endoscopy

Outcome Measures

Primary Outcomes (2)

• Ultra-sensitive Troponin I plasma level

  Ultra-sensitive Troponin I plasma level variation following upper and lower GI endoscopy. Troponin I will be measured immediately prior to anaesthesia induction (IV line placement) and before patient discharge of the hospital, i.e.: 4 (±1) hours after the procedure.

  4 hours

• Ultra-sensitive Troponin I plasma level variation following upper and lower GI endoscopy.

  Ultra-sensitive Troponin I plasma level variation following upper and lower GI endoscopy. Troponin I will be measured immediately prior to anaesthesia induction (IV line placement) and before patient discharge from the hospital, i.e.: 4 (±1) hours after the procedure

  4 hours

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients considered high risk

You may qualify if:

• Outpatients scheduled for upper and lower GI endoscopy
• ASA class 3 or 4: patients considered by anesthesiologists at "high risk" of postoperative complications, based on their comorbidities

You may not qualify if:

• Patients with renal failure, with glomerular filtration rate\<40 ml/min
• Patient not covered by social security
• Patient is pregnant
• Protected Patients

Sponsors & Collaborators

• European Society of Anaesthesiology: lead

Central Study Contacts

Bernard Professor. Cholley, Professor

CONTACT

003367176 82; bernard.cholley@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: September 18, 2025
• Study Start: January 15, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share