Perioperative ischemic evaluation study (POISE study)

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 10000

Inclusion Criteria

1. Greater than or equal to 45 years of age, either sex
2. Have an expected length of stay greater than or equal to 24 hours
3. Fulfill any one of the following six criteria:
3.1. Coronary artery disease
3.2. Peripheral vascular disease
3.3. History of stroke due to atherothrombotic disease
3.4. Hospitalisation for congestive heart failure within 3 years of randomisation
3.5. Undergoing major vascular surgery
3.6. Any three of the following seven criteria: scheduled for high risk surgery (i.e. intraperitoneal or intrathoracic), emergency/urgent surgery, any history of congestive heart failure, history of a transient ischaemic attack (TIA), diabetes and currently on an oral hypoglycaemic agent or insulin therapy, preoperative serum creatinine greater than 175 µmol/l (greater than 2.0 mg/dl), or age greater than 70 years
4. Are able to give written consent

Exclusion Criteria

1. Contradiction to metoprolol including any of the following: significant bradycardia (heart rate less than 50 beats per minute); second or third degree heart block without a pacemaker, asthma that has been active within the last decade, and history of chronic obstructive pulmonary disease (COPD) with bronchospasm on pulmonary function tests
2. Clinical plan to use a beta-blocker preoperatively or during the first 30 postoperative days
prior adverse reaction to a beta-blocker
3. Coronary artery bypass graft (CABG) surgery with complete revascularisation in the preceding 5 years and no evidence of cardiac ischaemia since the CABG surgery
4. Patients undergoing low risk surgical procedures (potential examples include transurethral procedures [transurethral prostatectomies {TURPs}, stone baskets etc.], ophthalmologic procedures under topical or regional anaesthesia [cornea transplants, cataract surgery etc.], and surgeries with limited physiological stresses [digital re-implantation, nerve repairs etc.])
5. Concurrent use of verapamil
6. Prior enrolment in this trial

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cardiac death at 30 days, nonfatal myocardial infarction (MI), and nonfatal cardiac arrest

Secondary Outcome Measures

Name	Time	Method
1. Length of hospital stay<br>2. Length of stay in an ICU/CCU<br>3. Revascularisation procedures (i.e. coronary artery bypass surgery and percutaneous transluminal coronary angioplasty)<br>4. Pulmonary oedema<br>5. Clinically significant atrial fibrillation<br>6. Stroke<br>7. Total mortality<br>8. Rehospitalisation for cardiac reasons<br>9. Myocardial infarction<br>10. Nonfatal cardiac arrest<br>11. Cardiovascular mortality<br>12. Clinically significant hypotension<br>13. Clinically significant bradycardia