The Effect of 12 Lead ECG Telemetry on Reperfusion Time in Resource-limited Settings
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 4
- 主要终点
- Reperfusion Time
研究概览
简要总结
This study aims to determine whether prehospital 12 lead ECG telemetry decreases the time to reperfusion in patients presenting with STEMI. A randomised controlled trial will be conducted in Gauteng and the Western Cape among 100 adult patients (>18 years) presenting with ST-elevation myocardial infarction according to a specific inclusion and exclusion criteria outlined in the full protocol. Consenting patients will be randomly assigned to have their prehospital ECG sent to the receiving cardiac facility or not. The onset-to-reperfusion and door-to-reperfusion times will be recorded and compared between the two groups by using the Fisher's exact test and a simple unpaired Student's t-test. Data will also be subjected to multivariate analysis of variance to test for statistical significance within a variety of factors that may influence reperfusion times.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (> 18 years of age)
- •Patients presenting within the Gauteng or Western Cape areas
- •Current chest pain or dyspnoea, presumed to be of cardiac origin
- •ST-elevation (STEMI) on the ECG (defined as ST-elevation of 0.1 mV in two or more contiguous leads).
排除标准
- •Non-adult patients
- •Chest pain of non-cardiac aetiology (following trauma or due to a primary respiratory pathology)
- •Non-consent to inclusion within the study
- •Patients without medical aid or who states that they cannot afford private healthcare.
- •Non-ST-elevation myocardial infarction
研究组 & 干预措施
Telemetry
In this group, participants will have a prehospital 12 lead ECG taken and sent through to the receiving facility.
干预措施: Telemetry (Other)
Non-Telemetry
In this group, participants will have a prehospital 12 lead ECG taken which will not be sent through to the receiving facility.
干预措施: Non-telemetry (Other)
结局指标
主要结局
Reperfusion Time
时间窗: At the first moment of reperfusion, from the date of randomisation up to 14 days
This outcome measures the time it takes to reperfuse a coronary artery in STEMI
次要结局
- Onset to reperfusion time(At the first moment of reperfusion, from the date of randomisation up to 14 days)
- Prehospital Time(On arrival at hospital; from the time of randomisation up to six hours)
研究者
Willem Stassen
Principal Investigator
Karolinska Institutet