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Clinical Trial NCT06324461 (GLUMINS) for Myocardial Injury is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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The University of Hong KongGLP-1 Receptor Agonist for Reduction of Myocardial Injury After Non-cardiac Surgery (GLUMINS) Phase 4 372 Randomized Multi-Center Open-Label Investigator-Initiated
Clinical Trial NCT06324461 (GLUMINS) is designed to study Prevention for Myocardial Injury. It is a Phase 4 interventional study that is recruiting, having started on March 20, 2024, with plans to enroll 372 participants. Led by The University of Hong Kong, it is expected to complete by December 31, 2028. The latest data from ClinicalTrials.gov was last updated on August 22, 2025.
Brief Summary
This is an investigator initiated, multi-center, open-labelled, superiority randomized controlled trial of 372 patients undergoing elective non-cardiac surgery. Recruited patients will be randomized in a 2:1 ratio to receive single subcutaneous dose of Glucagon-like Peptide-1 Receptor Agonist (GLP-1 RAs) 1 to 14 days prior to surgery or receive routine care.
Dulaglutide (Trulicity; Eli Lilly, USA) is chosen as GLP-1...
Show MoreDetailed Description
Myocardial injury following non-cardiac surgery (MINS) is increasingly recognized as a major cause of peri-operative morbidity and mortality worldwide. MINS is defined as post-operative cardiomyocyte injury that can be detected by high-sensitive troponin assays, which may or may not be associated with symptoms or changes on electrocardiogram (ECG). Globally, it was found that 35.5% patients had MINS with elevated tro...Show More
Official Title
Glucagon-like Peptide-1 Receptor Agonist for Reduction of Myocardial Injury After Non-Cardiac Surgery
Conditions
Myocardial InjuryPublications
Scientific articles and research papers published about this clinical trial:- Writing Committee for the VSI, Devereaux PJ, Biccard BM, Sigamani A, Xavier D, Chan MTV, Srinathan SK, Walsh M, Abraham V, Pearse R, Wang CY, Sessler DI, Kurz A, Szczeklik W, Berwanger O, Villar JC, Malaga G, Garg AX, Chow CK, Ackland G, Patel A, Borges FK, Belley-Cote EP, Duceppe E, Spence J, Tandon V, Williams C, Sapsford RJ, Polanczyk CA, Tiboni M, Alonso-Coello P, Faruqui A, ...
Other Study IDs
- GLUMINS
NCT ID Number
Start Date (Actual)
2024-03-20
Last Update Posted
2025-08-22
Completion Date (Estimated)
2028-12-31
Enrollment (Estimated)
372
Study Type
Interventional
PHASE
Phase 4
Status
Recruiting
Keywords
Myocardial injury following non-cardiac surgery
glucagon-like peptide 1 receptor agonists
Dulaglutide
glucagon-like peptide 1 receptor agonists
Dulaglutide
Primary Purpose
Prevention
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalDulaglutide group Subject randomized into this group will receive single subcutaneous dose of Dulaglutide 0.75mg 1 to 14 days prior to surgery, on top of routine peri-operative care | Dulaglutide 0.75mg subcutaneous injection Subject randomized into treatment group will receive single subcutaneous dose of Dulaglutide 0.75mg 1 to 14 days prior to surgery |
No InterventionControl group Subject randomized into this group will receive routine peri-operative care | N/A |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Proportion of patients with MINS | Defined as any elevation in troponin T \>= 14ng/L | Within 72 hours after surgery |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Proportion of patients with composite of non-fatal MINS, non-fatal stroke or cardiovascular mortality | Within 30 days of randomization | |
Proportion of patients with MINS who do not fulfill the 4th universal definition of myocardial infarction | Within 30 days of randomization | |
Proportion of patients with myocardial infarction according to the 4th universal definition of myocardial infarction | Within 30 days of randomization | |
Proportion of patients with ischemic stroke | Within 30 days of randomization | |
Proportion of patients with cardiovascular death | Within 30 days of randomization | |
Proportion of patients with all-cause mortality | Within 30 days of randomization | |
Mean days alive and out of hospital | Within 30 days of randomization | |
Clinically important atrial fibrillation | Within 30 days of randomization | |
Clinically significant hypoglycaemia | Within 30 days of randomization | |
Mean peak troponin T concentration | During the period of index hospitalization up to 3 days | |
Mean area under curve of troponin T concentration | During the period of index hospitalization up to 3 days |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- Age ≥ 18 years
- Planned elective intermediate to high risk non-cardiac surgery under general anesthesia
- Anticipated to remain hospitalized for at least one night after surgery
- Voluntarily agrees to participate by providing written informed consent
- History of symptomatic hypoglycemia within 1 month of recruitment
- History of pancreatitis
- Diabetic retinopathy
- Personal or family history of medullary thyroid carcinoma (MTC)
- Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
- Acute coronary syndrome, decompensated heart failure, cardiogenic shock, or myocarditis within 1 month of recruitment
- Stroke or transient ischemic attack within 1 month of recruitment
- Known severe liver disease (Child-Pugh B or C)
- Stage 5 chronic kidney disease (estimated glomerular filtration rate (eGFR) by Modified Diet in Renal Disease (MDRD) equation < 15 mL/min)
- Recent use of GLP-1 RA within 1 month of recruitment
- Known allergy or hypersensitivity to GLP-1 RA
- Women of childbearing age who are not taking effective contraception, or who are pregnant or breast-feeding
- Use of Dipeptidyl peptidase-4 inhibitor(DPP4i)
The University of Hong Kong335 active studies to exploreResearch Grants Council, Hong KongStudy Responsible Party
Wong Chun Ka, Principal Investigator, Clinical Assistant Professor, The University of Hong Kong
Study Central Contact
Contact: Chun Ka Wong, Clinical Assistant Professor, +852 2255 3597, [email protected]
Contact: Lily Hung, Bachelor, +852 2255 4169, [email protected]
3 Study Locations in 1 Countries
Hong Kong SAR
Duchess of Kent Children's Hospital at Sandy Bay, Hong Kong, Hong Kong SAR, China
Not yet recruiting
Queen Mary Hospital, Hong Kong, Hong Kong SAR, China
Recruiting
Tung Wah Hospital, Hong Kong, Hong Kong SAR, China
Recruiting