GI EndoscopyNCT07179549
Evaluation of the Incidence of Myocardial Damage Following Upper and Lower Gastrointestinal Endoscopy in High-risk Patients
An observational study of GI Endoscopy, run by European Society of Anaesthesiology.
Trial summary
Hypoperfusion occurs following anaesthesia induction as a result of: 1. a reduction in venous return and cardiac output subsequent to the dilatation of the venous reservoir, and 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- GI Endoscopy
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2026to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients considered high risk
Who may be able to join
- 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
Who cannot join
- Symptomatic coronary artery disease at the time of inclusion
- Pulmonary embolism less than two weeks before inclusion
- Septic shock less than two weeks before inclusion
- Patients with renal failure, with glomerular filtration rate<40 ml/min
- Patient not covered by social security
- Patient is pregnant
- Protected Patients
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of the Incidence of Myocardial Damage Following Upper and Lower Gastrointestinal Endoscopy in High-risk Patients: MINS-Endoscopy Study
Hypoperfusion occurs following anaesthesia induction as a result of:
- a reduction in venous return and cardiac output subsequent to the dilatation of the venous reservoir, and
- 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.
Read more
Upper and lower gastro-intestinal (GI) endoscopies are frequently performed under sedation (i.e.: general anaesthesia without orotracheal intubation) as daycare procedures. More than 10% of all anaesthesia worldwide is administered for GI endoscopic procedures. A substantial proportion of patients undergoing these procedures have significant comorbidities, classifying them as ASA 3 or ASA 4. However, despite the higher risk associated to their comorbidities, these patients are most often monitored intraoperatively as if they were ASA 1 or ASA 2, i.e.: using intermittent oscillometric blood pressure measurements every 5 minutes, an electrocardioscope and peripheral oxygen saturation measurement. They are also usually considered eligible for daycare procedures. However, hypoperfusion occurs during upper and lower GI endoscopies as a result of anaesthesia combined with abdominal insufflation (stomach followed by colon) and always starts with a decrease in SV, followed by a decrease in MAP.
The exact incidence of MINS following endoscopic procedures in high-risk patients has not been investigated to our knowledge and is not known precisely. The first part of this pragmatic study would consist in collecting pre-op and post-op (4 hours post procedure) plasma troponin level in ASA 3 or ASA 4 patients scheduled for upper and lower GI endoscopy at the time of routine blood collection. The patient will also be monitored using a Clearsight® continuous hemodynamic monitoring device.
- Conditions
- GI Endoscopy
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start15 Jan 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GI EndoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Society of Anaesthesiology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07179549
- Sponsor's protocol ID
- MINS-Endoscopy Study
- Status last verified
- Sep 2025
- First submitted
- 16 Sep 2025
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: privacy, ethical, or regulatory reasons
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Incidence of Myocardial Damage Following Upper and Lower Gastrointestinal Endoscopy in High-risk Patients: MINS-Endoscopy Study
- ClinicalTrials.gov ID
- NCT07179549
- Acronym / sponsor ID
- MINS-Endoscopy Study
- Conditions
- GI Endoscopy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- European Society of AnaesthesiologyUniversity, hospital or other
- Study start
- 15 Jan 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 18 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hypoperfusion occurs following anaesthesia induction as a result of:
- a reduction in venous return and cardiac output subsequent to the dilatation of the venous reservoir, and
- 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.
Upper and lower gastro-intestinal (GI) endoscopies are frequently performed under sedation (i.e.: general anaesthesia without orotracheal intubation) as daycare procedures. More than 10% of all anaesthesia worldwide is administered for GI endoscopic procedures. A substantial proportion of patients undergoing these procedures have significant comorbidities, classifying them as ASA 3 or ASA 4. However, despite the higher risk associated to their comorbidities, these patients are most often monitored intraoperatively as if they were ASA 1 or ASA 2, i.e.: using intermittent oscillometric blood pressure measurements every 5 minutes, an electrocardioscope and peripheral oxygen saturation measurement. They are also usually considered eligible for daycare procedures. However, hypoperfusion occurs during upper and lower GI endoscopies as a result of anaesthesia combined with abdominal insufflation (stomach followed by colon) and always starts with a decrease in SV, followed by a decrease in MAP.
The exact incidence of MINS following endoscopic procedures in high-risk patients has not been investigated to our knowledge and is not known precisely. The first part of this pragmatic study would consist in collecting pre-op and post-op (4 hours post procedure) plasma troponin level in ASA 3 or ASA 4 patients scheduled for upper and lower GI endoscopy at the time of routine blood collection. The patient will also be monitored using a Clearsight® continuous hemodynamic monitoring device.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients considered high risk
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (7 listed)
- Symptomatic coronary artery disease at the time of inclusion
- Pulmonary embolism less than two weeks before inclusion
- Septic shock less than two weeks before inclusion
- Patients with renal failure, with glomerular filtration rate<40 ml/min
- Patient not covered by social security
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Ultra-sensitive Troponin I plasma level
Time frame: 4 hours
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.
Ultra-sensitive Troponin I plasma level variation following upper and lower GI endoscopy.
Time frame: 4 hours
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- Individual participant dataSharing planned: No. privacy, ethical, or regulatory reasons
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of GI Endoscopy, run by European Society of Anaesthesiology.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bernard Professor. Cholley, Professor (003367176 82, bernard.cholley@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ultra-sensitive Troponin I plasma level (time frame: 4 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025.