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Clinical Trials/ISRCTN17233551
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.

Registry
who.int
Start Date
August 19, 2005
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
McMaster University (Canada)

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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