Use and Impact of the Pre-hospital 12-lead Electrocardiogram in the Primary PCI Era: Mixed Methods Study (PHECG2)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 420,048
- 试验地点
- 3
- 主要终点
- WP1: 30-day mortality
研究概览
简要总结
The Pre-Hospital 12-lead electrocardiogram (PHECG) is a simple test that helps ambulance clinicians assess patients with suspected acute coronary syndrome (heart attack), and provides clinical data to inform ongoing care. This project builds on previous work by this team, which found that one in three eligible patients did not receive a PHECG, but those that did had a lowered risk of short-term death. In this study the investigators will update that work, and explore reasons for variations in practice - highlighting opportunities to improve care and outcomes.
Using routinely collected data and qualitative methods, the investigators will research patient, practitioner and contextual factors contributing to the decision to administer a PHECG. The aim is also to develop an intervention to increase the proportion of eligible patients that receive a PHECG, and to produce a proposal for further funding to test this intervention in a subsequent randomised trial.
详细描述
This mixed methods design study consists of four work packages:
WP1 - Population-based, linked cohort study using MINAP data from 2010-2016
This work package will entail analysis of data from around 420,000 pseudonymised patient records from the MINAP database, linking to the Office for National Statistics (ONS) in order to determine mortality/vital status. No patients will be contacted to obtain consent for inclusion of their records in the study as NICOR (custodian of MINAP data) hold section 251 exemption to hold and process patient data for clinical audit purposes without their explicit consent. The data will be released to the research team, using established processes, in pseudonymised format.
The study statisticians will analyse the data provided from MINAP to determine how many heart attack patients who came by ambulance survive to 30 days, estimate time to death, and will estimate from the data whether more people who had an ambulance ECG survive compared to those who did not have the test.
The aim of the study is also to determine from the data whether patients who have an ambulance ECG receive treatment in hospital faster than those who did not.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 110 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients > 18 years of age
- •Patients with ACS
- •Patients who have been brought to hospital by Emergency Medical Service (EMS)
- •Patients included in the MINAP registry
- •First episode of ACS
- •Patients with confirmed STEMI and NSTEMI
- •EMS personnel trained in performing an ECG in the pre-hospital setting
- •EMS personnel involved in care of patients with a suspected heart attack
排除标准
- •patients < 18 years of age
- •patients who self-presented at hospitals with suspected ACS
- •patients who developed ACS whilst in hospital
结局指标
主要结局
WP1: 30-day mortality
时间窗: 30 days
Proportion of patients who die within 30 days of the date of their event
次要结局
- One year mortality(One year)
- Hospital mortality(Up to 90 days)
- Time to treatment(24 hours)
- Time to death(Up to one year)
- Use and type of reperfusion(24 hours)
- Time under care of EMS(Up to 3 hours)