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CompletedNCT01423136PROSE 3Updated Jun 2, 2014

Remote Electrocardiographic (ECG) ST-Monitoring (PROSE 3)in Post-op Patients

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

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
89
Ages
55 Years and older
Sex
All
01

Study 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 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.

Read the 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 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.

02

Conditions studied

  • Cardiac Complication
  • Postoperative Complications

Keywords

  • Patients undergoing non-cardiac Surgery
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In context

Postoperative Complications

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 →

Lead sponsor

Ottawa Hospital Research Institute is the lead sponsor of 538 studies on the registry; 100 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients under-going non-cardiac Sx with moderate to high risk of postoperative cardiovascular complications

Inclusion criteria

  • 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:

    1. 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
    2. 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

    3. 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)
    4. Hospitalization for CHF within 3 years of randomization
    5. Undergoing major open vascular surgery
    6. 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 criteria

Exclusion Criteria:

  • 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.
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
89 participants (actual)

Groups and cohorts

  • Routine postop care + Holter Monitoring

    With sham remote ECG ST Monitoring

  • Routine postop care + Holter + remote ECG monitoring

    Device: Remote ECG monitoring Spacelab SL 1050

Interventions

  • DeviceRemote ECG monitoring Spacelab SL 1050

    If ischemia noted, Sx will be notified and currently accepted treatments of myocardial ischemia will be recommended.

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What researchers measure

Primary outcomes

  1. 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

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Study locations

1 site
  • The Ottawa Hospital
    Ottawa, Ontario K1Y 4E9, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 2, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01423136
Lead sponsor
Ottawa Hospital Research Institute
Collaborators
The Ottawa Hospital Academic Medical Association
Responsible party
Sponsor
First posted
Aug 25, 2011
Start date
Oct 2010
Primary completion
Mar 2012
Completion
Oct 2012
Last update
Jun 2, 2014

Study contacts

H. Yang, MD
principal investigator · Ottawa Hospital Research Institute

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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