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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01423136
Recruitment Status : Completed
First Posted : August 25, 2011
Last Update Posted : June 2, 2014
The Ottawa Hospital Academic Medical Association
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

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 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.

Condition or disease Intervention/treatment
Cardiac Complication Postoperative Complications Device: Remote ECG monitoring Spacelab SL 1050

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.

Study Type : Observational
Actual Enrollment : 89 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Postop Remote ECG ST-Monitoring (PROSE 3)
Study Start Date : October 2010
Actual Primary Completion Date : March 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: After Surgery
U.S. FDA Resources

Group/Cohort Intervention/treatment
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
If ischemia noted, Sx will be notified and currently accepted treatments of myocardial ischemia will be recommended.

Primary Outcome Measures :
  1. duration of postop myocardial ischemia [ Time Frame: 48 hours ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Senior)
Sexes Eligible for Study:   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:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01423136

Canada, Ontario
The Ottawa Hospital
Ottawa, Ontario, Canada, K1Y 4E9
Sponsors and Collaborators
Ottawa Hospital Research Institute
The Ottawa Hospital Academic Medical Association
Principal Investigator: H. Yang, MD Ottawa Hospital Research Institute

Responsible Party: Ottawa Hospital Research Institute Identifier: NCT01423136     History of Changes
Other Study ID Numbers: 2009521-01H
First Posted: August 25, 2011    Key Record Dates
Last Update Posted: June 2, 2014
Last Verified: May 2014

Keywords provided by Ottawa Hospital Research Institute:
Patients undergoing non-cardiac Surgery

Additional relevant MeSH terms:
Postoperative Complications
Pathologic Processes