Perioperative Ischemia Reduction Study (PROSE) Pilot

NCT00665028 | Completed

• 1 other identifier: 2007246-01H
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

After surgery, patients who have cardiogram changes consistent with a lack of oxygen to the heart muscles, also known as myocardial ischemia, have been found to have 9 times the chance of having an event such as a heart attack during the subsequent 30 days. It is not known if monitoring and treating ischemia will prevent events such as heart attacks. It is not known if such monitoring and treatment can be done on the regular surgical wards. In this pilot study, we hope to demonstrate that such a study is feasible, and the maintenance of blinding is possible. The primary outcomes are to show that such monitoring after surgery is possible in ≥ 95% of patients, to show that response and treatment to such ischemia in ≤ 1 hour is possible in ≥ 90% of patients, and that blinding between the standard and active treatment groups is possible for 50% ± 1 s.d.. With the pilot study data, if successful, we will be applying for peer-reviewed funding for a full study.

Conditions

Myocardial Ischemia

Keywords

Anesthesia; Postoperative myocardial ischemia; ST monitoring

Outcome Measures

Primary Outcomes (2)

• Perioperative Ischemia Reduction Study Pilot (PROSE) & (PROSE 2)

  Observational study on feasibility of remote ECG ST monitoring on a wireless system.

  12 months

• Feasibility of remote wireless ECG ST monitoring

  To study the feasibility of real-time remote wireless ECG ST monitoring through wireless infrastructure of the hospital

  24 months

Study Arms (1)

1

Postoperative myocardial ischemia

Eligibility Criteria

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

Study Population

Elective non-cardiac surgical procedure

You may qualify if:

• Age 55 years
• RCRI Class; 3 (i.e. 2 factors)
• Elective non-cardiac surgical procedure
• Expected to stay in hospital 2 days

You may not qualify if:

• Atrial fibrillation
• Left bundle branch block (LBBB)
• Pacemaker dependency
• Digoxin
• CABG / PCI within 5 years
• Low risk surgery (TURP, digit re-implantation, nerve repair, etc)
• Expected ICU admission
• CO2 retention
• Refusal to transfusions
• Adverse drug reaction to NSAIDS, beta-blockers, Ca-channel blockers, statins, nitrates
• Prior enrolment in PROSE

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• SpaceLab: collaborator
• Research in Motion: collaborator
• Globestar: collaborator

Study Sites (1)

The Ottawa Hospital

Ottawa, Ontario, K1Y 4E9, Canada

Location

MeSH Terms

Conditions

Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• H Yang, MD

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 21, 2008
• First Posted: April 23, 2008
• Study Start: November 1, 2007
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: January 8, 2015

Record last verified: 2015-01

Locations

CA (1)