A Pilot Study of the Feasibility of Prehospital Delivery of Remote Ischemic Conditioning by Emergency Medical Services in Chest Pain Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Percent of Subjects Receiving 4 Cycles of RIC Without Interruption
研究概览
简要总结
Prospective, single center, single arm pilot study evaluating the feasibility of delivering remote ischemic conditioning (RIC) by emergency medical services (EMS) in the prehospital setting. Eligible patients will have chest pain or anginal equivalent symptoms and require ground ambulance transport to the hospital. All subjects will undergo the standard RIC procedure (i.e., up to four cycles of alternating 5-min inflation and 5-min deflation) with the autoRIC® device (CellAegis Devices, Inc., Toronto, Ontario). The primary objective is to evaluate the number of cycles of RIC completed in patients having the procedure initiated by EMS in the prehospital setting.
详细描述
This single-arm, open-label pilot study will evaluate the feasibility of delivering remote ischemic conditioning (RIC) by emergency medical services (EMS) in the prehospital setting. Eligible patients will be at least 18 years of age, and require ground ambulance transport to the hospital. Patients suspected of ST-elevation myocardial infarction (STEMI) based on the prehospital electrocardiogram and thus requiring urgent intervention in the cardiac catheterization lab will be excluded.
All subjects will undergo the standard RIC procedure (i.e., up to four cycles of alternating 5-min inflation and 5-min deflation) with the autoRIC® device (CellAegis Devices, Inc.). The automated procedure will be initiated by paramedics during ambulance transport, and the RIC cycles will continue through emergency department (ED) arrival and stay for a total of 40 minutes.
The primary objective of this pilot study is to examine the duration of RIC administered in patients having the procedure initiated in the prehospital setting. The investigators hypothesize four cycles of RIC will be completed in at least 80% of patients having the procedure initiated. Secondary objectives are to assess enrollment rates and protocol implementation; paramedic acceptability of protocol; and patient tolerability of RIC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Requiring 9-1-1 response to scene
- •At least 18 years of age
- •Experiencing non-traumatic chest pain or anginal equivalent symptom
- •Not meeting EMS criteria for a suspected STEMI based on prehospital ECG
- •Systolic blood pressure (SBP) between 100-180 mgm Hg
- •Designated for ambulance transport to University of North Carolina Medical Center (Chapel Hill, NC)
- •Capable of providing informed consent
排除标准
- •Unconscious or otherwise in critical condition
- •Lacking capacity to consent to the study
- •Non-English speaking
- •Pre-existing condition precluding blood pressure check or use of the autoRIC® at the discretion of the provider or listed here:
- •Paresis of upper limb
- •Pre-existing traumatic injury to arm
- •Presence of an arteriovenous shunt for dialysis
- •Prior mastectomy
- •Existing peripheral inserted central catheter line
- •Arm edema or other indication of upper extremity thrombosis
- •Serial ECG evidence of evolving STEMI
研究组 & 干预措施
Remote Ischemic Conditioning
RIC procedure (i.e., four cycles of alternating 5-min inflation and 5-min deflation) administered by the autoRIC® device
干预措施: autoRIC® device (Device)
结局指标
主要结局
Percent of Subjects Receiving 4 Cycles of RIC Without Interruption
时间窗: up to 40 minutes, following initiation of RIC
A completed RIC cycle without interruption is defined as 5 minutes inflation followed by 5 minutes deflation for a total of 10 minutes.
次要结局
- Themes on Patient Experiences While Undergoing RIC(up to 15 minutes)
- Percent of Patients Recruited Who Agreed to Participate(through EMS transport, an average of 20 minutes)
- Timing (in Minutes) of Study Procedures(through EMS response and transport, an average of 30 minutes)
- Percent of Patients Screened Who Are Eligible for Recruitment(through EMS transport, an average of 20 minutes)
- Percent of Participants Experiencing Anticipated Adverse Events Including RIC Discontinuation Due to Discomfort(up to 48 hours from end of RIC)
- Themes on Paramedic Acceptability of the Study Protocol(up to 15 minutes from screening)