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临床试验/NCT00665028
NCT00665028已完成不适用

Perioperative Ischemia Reduction Study (PROSE) Pilot

Ottawa Hospital Research Institute1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2007年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Feasibility of remote wireless ECG ST monitoring

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
55 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • Atrial fibrillation
  • Left bundle branch block (LBBB)
  • Pacemaker dependency
  • 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

结局指标

主要结局

Feasibility of remote wireless ECG ST monitoring

时间窗: 24 months

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

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

时间窗: 12 months

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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