ISRCTN17233551
Completed
Not Applicable
Perioperative ischemic evaluation study (POISE study)
McMaster University (Canada)0 sites10,000 target enrollmentAugust 19, 2005
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cardiovascular
- Sponsor
- McMaster University (Canada)
- Enrollment
- 10000
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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