Perioperative Ischemia Reduction Study (PROSE) Pilot
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ClinicalTrials.gov Identifier: NCT00665028 |
Recruitment Status
:
Completed
First Posted
: April 23, 2008
Last Update Posted
: January 8, 2015
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Condition or disease |
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Myocardial Ischemia |
Perioperative myocardial ischemia has been studied in the pre-, intra-, and postoperative periods. The intraoperative incidence is similar to the preoperative period but the postoperative incidence is doubled that of the preoperative period. These results have two implications: postoperative myocardial ischemia cannot be predicted by preoperative ambulatory ECG monitoring since only half of those are seen preoperatively; the postoperative period is when significant myocardial ischemia occurs.
The role of myocardial ischemia, especially prolonged ischemia, in perioperative myocardial infarction (PMI) has been recognized by a number of investigators. In the presence of postoperative myocardial ischemia, the relative risk of a postoperative cardiac event was 16 in one study and the odds ratio for an ischemic cardiac event was 9.2 in another. Using 12-lead continuous monitoring, one study found that all PMI were preceded by myocardial ischemia.
Ambulatory ECG in the postoperative period has been well reported in the past. Recently, Landesberg reported the sensitivity and specificity of lead placements to detect myocardial ischemia in the postoperative period. Lead combinations were compared with continuous 12-lead ECG in 185 consecutive patients. Combining two precordial leads, the sensitivity for detecting ischemia was 97.4% for V3 + V5; 92.1% for V4 + V5; and for infarction was 100% for V3 + V5 or V4 + V5.
We believe that the pathogenesis of PMI is multifactorial. Apart from the coronary anatomy and the vulnerable plaque, stress hormones and catecholamine surges in the perioperative period are well reported. Stress increases systolic BP, which is a major determinant of LV wall tension, and hence, myocardial oxygen demand. The oxygen cost of "pressure work" is greater than "volume work", with the area-under-the-curve for LV pressure closely correlating with myocardial oxygen demand. Hypercoagulable state has also been implicated in PMI.
With so many possible pathogenesis, it is our belief therefore that postoperative myocardial ischemia may be one of the final pathways just before postoperative ischemic cardiac complications. This is especially so when all PMI were preceded by myocardial ischemia in one study. With potentially multiple pathogenesis, it is unknown if postoperative myocardial ischemia is amenable to treatment. It is, however, our belief that postoperative myocardial ischemia can be aborted using existing treatment modalities. The implication is that the reduction of postoperative myocardial ischemia may reduce the incidence of postoperative ischemic cardiac complications, including PMI.
Current standard of care does not include telemetry or real-time ST monitoring on surgical patients. Traditional telemetry would impede low-risk patients in their postoperative recovery by limiting them to their beds. In the context of real-time monitoring for ST changes in low-risk patients, the cost of traditional telemetry with nursing may also be prohibitive. We propose a novel technological application, transmitting wireless ST segment monitoring and alarms to a Blackberry. This will alert the research team to verify via "full disclosure" on the ST monitor and respond directly. SpaceLab, GlobeStar, and Research in Motion (RIM) have developed the hardware and software respectively. We currently have written assurances and support from SpaceLab, GlobeStar, and RIM to conduct a pilot study for this novel application (see attached). We therefore propose a pilot study to determine the feasibility of wireless ST-segment monitoring and its treatment in post-surgical patients.
Study Type : | Observational |
Actual Enrollment : | 30 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Perioperative Ischemia Reduction Study (PROSE) Pilot |
Study Start Date : | November 2007 |
Actual Primary Completion Date : | April 2012 |
Actual Study Completion Date : | April 2012 |

Group/Cohort |
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1
Postoperative myocardial ischemia
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- Perioperative Ischemia Reduction Study Pilot (PROSE) & (PROSE 2) [ Time Frame: 12 months ]Observational study on feasibility of remote ECG ST monitoring on a wireless system.
- Feasibility of remote wireless ECG ST monitoring [ Time Frame: 24 months ]To study the feasibility of real-time remote wireless ECG ST monitoring through wireless infrastructure of the hospital

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Ages Eligible for Study: | 55 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Age 55 years
- RCRI Class; 3 (i.e. 2 factors)
- Elective non-cardiac surgical procedure
- Expected to stay in hospital 2 days
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00665028
Canada, Ontario | |
The Ottawa Hospital | |
Ottawa, Ontario, Canada, K1Y 4E9 |
Principal Investigator: | H Yang, MD | Ottawa Hospital Research Institute |
Responsible Party: | Ottawa Hospital Research Institute |
ClinicalTrials.gov Identifier: | NCT00665028 History of Changes |
Other Study ID Numbers: |
2007246-01H |
First Posted: | April 23, 2008 Key Record Dates |
Last Update Posted: | January 8, 2015 |
Last Verified: | January 2015 |
Keywords provided by Ottawa Hospital Research Institute:
Anesthesia Postoperative myocardial ischemia ST monitoring |
Additional relevant MeSH terms:
Ischemia Myocardial Ischemia Coronary Artery Disease Pathologic Processes Heart Diseases |
Cardiovascular Diseases Vascular Diseases Coronary Disease Arteriosclerosis Arterial Occlusive Diseases |