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Completed

NCT Number: NCT01423136

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

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.

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Key information

Age range

55 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Ottawa Hospital

Ottawa, Ontario, K1Y 4E9, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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 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.

Treatment and study plan

Remote ECG monitoring Spacelab SL 1050

Device

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

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Ottawa Hospital Research Institute

Other

Collaborators

  • The Ottawa Hospital Academic Medical Association

Registry information

Official study title

Postop Remote ECG ST-Monitoring (PROSE 3)

Acronym: PROSE 3

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Aug 25, 2011
Registry last updated
Jun 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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