Status:
COMPLETED
Remote Electrocardiographic (ECG) ST-Monitoring (PROSE 3)in Post-op Patients
Lead Sponsor:
Ottawa Hospital Research Institute
Collaborating Sponsors:
The Ottawa Hospital Academic Medical Association
Conditions:
Cardiac Complication
Postoperative Complications
Eligibility:
All Genders
55+ years
Brief Summary
In moderate to high risk patients, cardiovascular complications after surgery account for almost 60% of death after surgery. This study will randomize 140 patients into routine postop care with Holter...
Detailed Description
This proposal aims to improve the process and quality of care in the postoperative period by early detection of ischemia and prompt use of accepted therapies in order to prevent postoperative myocardi...
Eligibility Criteria
Inclusion
- Age ≥ 55 years, undergoing non-cardiac surgery with an expected LOS ≥ 2 days, who fulfills at least one of the six criteria for increased risk:
- History of CAD as defined by any of the following 6 criteria i. history of angina ii. prior myocardial infarction iii. prior positive exercise stress test iv. prior documentation of cardiac ischemia on nuclear stress testing v. prior coronary artery arteriographic evidence of atherosclerotic stenosis \> 50% of vessel diameter vi. ECG with pathological Q waves in two contiguous leads
- PVD as defined by any one of the following 3 criteria:
- i. intermittent claudication (i.e. leg pain on walking that disappears in\< 10 minutes on standing) that is known or likely to be due to atherosclerotic disease ii. an ankle/arm systolic BP ratio \< 0.90 in either leg at rest iii. angiographic or Doppler study demonstrating \>70% stenosis
- History of stroke (i.e. deficit that persisted for at least 1 week after onset) thought due to atherothrombotic disease (i.e. NOT a lacunar stroke, hemorrhagic stroke, nor embolic stroke secondary to atrial fibrillation)
- Hospitalization for CHF within 3 years of randomization
- Undergoing major open vascular surgery
- Any 3 of the following 7 risk factors i. high risk type of surgery (eg. Open Intrathoracic, intraperitoneal, or major orthopedic surgery) ii. any history of congestive heart failure iii. diabetes and currently on oral hypoglycemic agents or insulin iv. preoperative serum creatinine \>175 micromol/L v. age \> 70 years vi. history of TIA (i.e. that lasted less than 24 hours) vii. urgent / emergent surgery
Exclusion
- Planned ICU admission; atrial fibrillation; left bundle branch block (LBBB); LVH with strain; pacemaker dependency interfering with ST analysis; hemodialysis; digoxin; CABG or PCI within 5 years without any recurrence of CAD by symptoms or cardiac investigations; surgery with low physiological trespasses such as digit re-implantation, nerve repair, etc.; COPD / asthma requiring bronchodilators within the last 12 months; refusal to transfusions; adverse drug reaction (ADR) to NSAIDS, beta-blockers, Ca-channel blockers, statins, nitrates; prior enrolment in PROSE.
Key Trial Info
Start Date :
October 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
89 Patients enrolled
Trial Details
Trial ID
NCT01423136
Start Date
October 1 2010
End Date
October 1 2012
Last Update
June 2 2014
Active Locations (1)
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1
The Ottawa Hospital
Ottawa, Ontario, Canada, K1Y 4E9