A Study of the Feasibility of Prehospital Remote Ischemic Conditioning
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|ClinicalTrials.gov Identifier: NCT03400579|
Recruitment Status : Completed
First Posted : January 17, 2018
Last Update Posted : November 14, 2019
|Condition or disease||Intervention/treatment||Phase|
|Chest Pain||Device: autoRIC® device||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Prospective, single center, single arm pilot study evaluating the feasibility of delivering remote ischemic conditioning by emergency medical services during ground ambulance transport of patients experiencing chest pain or anginal equivalent symptom|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of the Feasibility of Prehospital Delivery of Remote Ischemic Conditioning by Emergency Medical Services in Chest Pain Patients|
|Actual Study Start Date :||July 10, 2018|
|Actual Primary Completion Date :||September 30, 2019|
|Actual Study Completion Date :||October 1, 2019|
Experimental: Remote Ischemic Conditioning
RIC procedure (i.e., four cycles of alternating 5-min inflation and 5-min deflation) administered by the autoRIC® device
Device: autoRIC® device
The autoRIC® automatically delivers four RIC cycles of five minutes of pressure at 200 mm Hg followed by five minutes of no pressure for a total 40-min treatment period
- Percent of subjects receiving 4 cycles of RIC without interruption [ Time Frame: 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.
- Percent of patients screened who are eligible for recruitment [ Time Frame: through EMS transport, an average of 20 minutes ]Eligibility rates among patients screened and specifying inclusion and exclusion criteria met or not met.
- Percent of patients recruited who agreed to participate [ Time Frame: through EMS transport, an average of 20 minutes ]Participation rates among patients who are screened and recruited.
- Timing (in minutes) of study procedures [ Time Frame: through EMS response and transport, an average of 30 minutes ]Times will be reported for on-scene arrival, patient transport, screening, recruitment, and RIC initiation to assess efficiency with which the study protocol was implemented.
- Themes on paramedic acceptability of the study protocol [ Time Frame: up to 15 minutes ]Qualitative themes related to implementation of the study protocol will be derived from semi-structured interviews with study paramedics.
- Percent of patients experiencing anticipated adverse events including RIC discontinuation due to discomfort [ Time Frame: up to 48 hours from end of RIC ]Anticipated adverse events related to RIC including minor arm discomfort, temporary discoloration of the arm or hand, and minor skin bruising or abrasions on the upper arm will be collected via in-person and telephone evaluation.
- Themes on patient experiences while undergoing RIC [ Time Frame: up to 15 minutes ]Qualitative themes related to the RIC procedure will be derived from semi-structured interviews with subjects.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03400579
|United States, North Carolina|
|University of North Carolina at Chapel Hill|
|Chapel Hill, North Carolina, United States, 27599|
|Principal Investigator:||Mehul D Patel, PhD||University of North Carolina, Chapel Hill|