Pre-Hospital Wireless Transmission of Electrocardiograms to a Cardiologist Via a Hand-Held Device
Pre-hospital Wireless Transmission of Electrocardiograms to a Cardiologist Via a Hand-held Device: The TIME Multicenter Study
Aim: To determine the impact of wireless transmission of prehospital ECGs to a hand-held computer on time to treatment and myocardial salvage in acute MI patients.
Background: The TIME-1 investigators documented a 27% (109 to 80 minutes) reduction of time from EMT arrival at the scene to successful primary PCI implementing pre-hospital ECG transmission to the ED. ECG transmission directly to a physician's cellular phone/PDA through a wireless modem has only recently become an option. The recently completed TIME-NorthEast (NE) study tested the Welch Allyn version of this system and the results show a reduction in time to reperfusion for acute MI patients by 66 minutes (116 to 50).
Methods: This study will involve approximately 20 sites around the country. The study will be divided into two phases: a consecutive control data collection phase (Phase I) and an intervention with concurrent control phase (Phase II). Phase II will begin after installation of Welch Allyn ECG transmission equipment. The primary end-point will be time to reperfusion and secondary end-points will include myocardial salvage, aborted infarction and hospital mortality. ECG measurements will be made at a central ECG core lab by a blinded investigator.
Data Analysis: Patient characteristics for the three periods were compared with the chi-square statistic for categorical variables and one-way analysis of variance for age. The Wilcoxon rank-sum statistic was used to compare time-to-reperfusion in the pre-study and study periods as well as in the Group 1 post-study period. Comparisons were performed separately for EMS and self-transport groups.
研究概览
研究类型
注册 (实际的)
联系人和位置
学习地点
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California
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Salinas、California、美国、93901
- Salinas Valley Memorial Healthcare System
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Florida
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Gainesville、Florida、美国、32605
- Shands @ AGH
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Miami、Florida、美国、33143
- South Miami Heart Center
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North Carolina
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Durham、North Carolina、美国、27705
- Duke University Medical Center
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Durham、North Carolina、美国、27704
- Durham Regional Hospital
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Ohio
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Cincinnati、Ohio、美国、45242
- Bethesda North Hospital
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Pennsylvania
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Pittsburgh、Pennsylvania、美国、15213
- University of Pittsburgh Medical Center - Presbyterian
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
All patients with a diagnosis of acute STEMI defined as 1 mm ST segment elevation in two spatially contiguous leads were included. There were two major subgroups: emergency medical services (EMS) and self-transport patients. Self-transport patients, who did not have PH-ECG transmission, served as a comparison group.
Exclusion Criteria:
- Less than age 18
- No intent to undergo reperfusion therapy (PCI or thrombolytics)
学习计划
研究是如何设计的？
设计细节
- 观测模型：病例对照
队列和干预
团体/队列 |
干预/治疗 |
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Pre-study Period (Group 1 and Group 2).
The TIME-MC study was conducted from June 2003 to June 2008 at NEMC (Figure 1) and from May 2005 to September 2008 at the six larger medical centers (Figure 2). Two groups were studied. Group 1 included patients at NEMC and Group 2 included patients at the other six medical sites. The study was divided into three periods: Pre-study period (Group 1 and Group 2). No PH-ECG transmission system was available. |
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Study Period (Group 1 and Group 2)
Study period (Group 1 and Group 2).
PH-ECG transmission to a cardiologist's hand-held device was attempted through pre-assigned EMS ambulances equipped with a wireless ECG transmission device in addition to a STEMI code system.
In Group 1, this referred to the pilot study at NEMC from June 2003 to May 2005.
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All EMS transported patients age 18 or over who have their ECG attempted to be wirelessly transmitted and with the intention to treat with coronary reperfusion therapy (PCI or thrombolytics)based on their initial presentation.
其他名称：
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Post-study period (Group 1)
Post-study period (Group 1).
PH-ECG transmission and a STEMI code system implemented after the pilot study period.
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All EMS transported patients age 18 or over who have their ECG attempted to be wirelessly transmitted and with the intention to treat with coronary reperfusion therapy (PCI or thrombolytics)based on their initial presentation.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
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Door to intervention time - time from emergency department door time until intervention.
大体时间：time from emergency department door time until intervention.
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time from emergency department door time until intervention.
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次要结果测量
结果测量 |
大体时间 |
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Salvaged myocardial tissue - pre-hospital ECGs will be read using the Aldrich final MI size prediction to calculate the size of infarct that would be expected to result without reperfusion treatment.
大体时间：pre hospital ECG - discharge ECG
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pre hospital ECG - discharge ECG
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Aborted infarction-defined as combined ECG and cardiac biomarkers criteria:1.subsiding of ST deviation greater than or equal to 50% within 2 hours after reperfusion treatment. 2.rise in cardiac enzymes less than or equal to 2 times upper value of normal.
大体时间：2 hours after reperfusion treatment
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2 hours after reperfusion treatment
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Hospital mortality - whether the patient was discharged alive.
大体时间：discharge
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discharge
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No infarct related artery at time of heart catheterization.
大体时间：catheterization
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catheterization
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合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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