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Perioperative Ischemia Reduction Study (PROSE) Pilot

NCT00665028 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2015-01-08

No results posted yet for this study

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

Sponsors & Collaborators

  • SpaceLab

    collaborator UNKNOWN

  • Research in Motion

    collaborator UNKNOWN

  • Globestar

    collaborator UNKNOWN

  • Ottawa Hospital Research Institute

    lead OTHER

Principal Investigators

  • H Yang, MD · Ottawa Hospital Research Institute

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2012-04-30
Completion
2012-04-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00665028 on ClinicalTrials.gov