MANAGEMENT OF MYOCARDIAL INJURY AFTER NONCARDIAC SURGGERY (MANAGE) TRIA

Not Applicable

Recruiting

• Conditions: -I256 Silent myocardial ischaemia; Silent myocardial ischaemia; I256

• Registration Number: PER-034-14
• Lead Sponsor: POPULATION HEALTH RESEARCH INSTITUTE DE LA UNIVERSIDAD MC MASTER DE CANADA,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-11-12
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

Patients are eligible if they fulfill all of the following criteria: 1. undergone noncardiac surgery; 2. ≥45 years of age; 3. have suffered myocardial injury after noncardiac surgery (MINS) based upon fulfilling one of the following criterions: A. elevated troponin or CK-MB measurement with one or more of the following defining features: i. ischemic signs or symptoms; ii. development of pathologic Q waves; iii. electrocardiogram changes indicative of ischemia (i.e., ST segment elevation, ST segment depression, or inversion of T waves); iv. new LBBB, or v. new or presumed new cardiac wall motion abnormality on echocardiography or new or presumed new fixed defect on radionuclide imaging. B. elevated troponin measurement after surgery with no alternative explanation (e.g., pulmonary embolism) to MINS. and 4. provide written informed consent to participate while still in hospital after their index surgery and within 5 days of suffering their MINS

Exclusion Criteria

1. hypersensitivity or known allergy to dabigatran; 2. history of intracranial, intraocular, or spinal bleeding; 3. hemorrhagic disorder or bleeding diathesis; 4. condition that requires therapeutic dose anticoagulation 5. currently using or plan rifampicin, ketoconazole, or dronedarone; 6. women who are pregnant or of childbearing potential who refuse to use a medically acceptable form of contraception throughout the study; 7. patient is considered unreliable for study follow-up or study drug compliance; OR 8. previously enrolled. Patients in whom any of the following criteria persist beyond 5 days of their suffering MINS: 1. the attending surgeon believes it is not safe to initiate therapeutic dose anticoagulation therapy; 2. the attending physician believes ASA, intermittent pneumatic compression, and/or elastic stockings are not sufficient for VTE prophylaxis and that the patient requires a prophylactic-dose anticoagulant; 3. the patient has an indwelling epidural or spinal catheter that cannot be removed; 4. estimated glomerular filtration rate <35 ml/min, OR 5. it is expected that the patient will undergo cardiac catheterization for MINS . Exclusion criteria specific to patients in the omeprazole factorial component: 1. hypersensitivity or known allergy to omeprazole; 2. requirement for a PPI, an H2-receptor antagonist, sucralfate, or misoprostol; 3. esophageal or gastric variceal disease; OR 4. patient declines participation in omeprazole arm

Study & Design

• Study Type: Interventional
• Study Design: Not specified