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

This study has been completed.
Sponsor:
Collaborator:
The Ottawa Hospital Academic Medical Association
Information provided by (Responsible Party):
Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT01423136
First received: March 28, 2011
Last updated: May 30, 2014
Last verified: May 2014
  Purpose

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 Intervention
Cardiac Complication
Postoperative Complications
Device: Remote ECG monitoring Spacelab SL 1050

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Postop Remote ECG ST-Monitoring (PROSE 3)

Resource links provided by NLM:


Further study details as provided by Ottawa Hospital Research Institute:

Primary Outcome Measures:
  • duration of postop myocardial ischemia [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    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


Enrollment: 89
Study Start Date: October 2010
Study Completion Date: October 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
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

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01423136

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

No publications provided

Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT01423136     History of Changes
Other Study ID Numbers: 2009521-01H
Study First Received: March 28, 2011
Last Updated: May 30, 2014
Health Authority: Canada: Ethics Review Committee

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

Additional relevant MeSH terms:
Postoperative Complications
Pathologic Processes

ClinicalTrials.gov processed this record on September 18, 2014