An observational study in Cardiac Complication and Postoperative Complications, sponsored by Ottawa Hospital Research Institute. Completed at 1 site in Canada. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2014-06-02.
Sponsored by Ottawa Hospital Research Institute · Observational
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 monitoring versus routine postop care + remote ST monitoring + Holter monitoring. The response time to electrocardiographic (ECG) ST changes as well as the total ischemia time will be studied.
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 myocardial infarctions (PMI) in patients undergoing non-cardiac surgery. Specifically, it aims to validate the safety and efficacy of wireless remote real-time ECG ST-monitoring in the reduction of the incidence of PMI. It extends two pilot feasibility studies into the postoperative period using wireless remote ST-monitoring for early detection of myocardial ischemia followed by preventative strategies. It is anticipated that this research will improve postoperative care by adopting generalizable and practical strategies.
1,233 studies on the registry are indexed under Postoperative Complications; 292 are open to participants now.
This study's enrollment of 89 is below the median of 254 across 519 observational studies indexed under Postoperative Complications.
Browse Postoperative Complications studies →Ottawa Hospital Research Institute is the lead sponsor of 538 studies on the registry; 100 are open to participants now.
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Patients under-going non-cardiac Sx with moderate to high risk of postoperative cardiovascular complications
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:
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
Exclusion Criteria:
With sham remote ECG ST Monitoring
Device: Remote ECG monitoring Spacelab SL 1050
If ischemia noted, Sx will be notified and currently accepted treatments of myocardial ischemia will be recommended.
duration of postop myocardial ischemia
To determine if the duration of postoperative myocardial ischemia during real-time wireless management of ischemic ECG ST changes is half that of standard postop care, as determined by 48-hour ambulatory ECG monitoring
Time frame: 48 hours
This study is completed, as verified in May 2014. You cannot join it, but the record below documents what was studied.
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Ottawa Hospital Research Institute