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

NCT01423136 | Completed

• 1 other identifier: 2009521-01H
• Study Type: observational
• Target: 89
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Complication; Postoperative Complications

Keywords

Patients undergoing non-cardiac Surgery

Outcome Measures

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

  48 hours

Study Arms (2)

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

Remote ECG monitoring Spacelab SL 1050 DEVICE

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

Routine postop care + Holter + remote ECG monitoring

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• The Ottawa Hospital Academic Medical Association: collaborator

Study Sites (1)

The Ottawa Hospital

Ottawa, Ontario, K1Y 4E9, Canada

Location

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• H. Yang, MD

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2011
• First Posted: August 25, 2011
• Study Start: October 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: October 1, 2012
• Last Updated: June 2, 2014

Record last verified: 2014-05

Locations

CA (1)