A Study of the Feasibility of Prehospital Remote Ischemic Conditioning

Not Applicable

Completed

• Conditions: Chest Pain
• Interventions: Device: autoRIC® device

• Registration Number: NCT03400579
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2018-01-08
• Study First Submitted QC: 2018-01-12
• Study First Posted: 2018-01-17
• Study Start: 2018-07-10
• Primary Completion: 2019-09-30
• Study Completion: 2019-10-01
• Status Verified: 2019-11
• Results First Submitted: 2020-07-31
• Results First Submitted QC: 2020-08-19
• Last Update Submitted: 2020-08-19
• Results First Posted: 2020-09-01
• Last Update Posted: 2020-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1. Requiring 9-1-1 response to scene
2. At least 18 years of age
3. Experiencing non-traumatic chest pain or anginal equivalent symptom
4. Not meeting EMS criteria for a suspected STEMI based on prehospital ECG
5. Systolic blood pressure (SBP) between 100-180 mgm Hg
6. Designated for ambulance transport to University of North Carolina Medical Center (Chapel Hill, NC)
7. Capable of providing informed consent

Exclusion Criteria

1. Unconscious or otherwise in critical condition

2. Lacking capacity to consent to the study

3. Non-English speaking

4. Pre-existing condition precluding blood pressure check or use of the autoRIC® at the discretion of the provider or listed here:

   1. Paresis of upper limb
   2. Pre-existing traumatic injury to arm
   3. Presence of an arteriovenous shunt for dialysis
   4. Prior mastectomy
   5. Existing peripheral inserted central catheter line
   6. Arm edema or other indication of upper extremity thrombosis

5. Serial ECG evidence of evolving STEMI

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Remote Ischemic Conditioning	autoRIC® device	RIC procedure (i.e., four cycles of alternating 5-min inflation and 5-min deflation) administered by the autoRIC® device

Primary Outcome Measures

Name	Time	Method
Percent of Subjects Receiving 4 Cycles of RIC Without Interruption	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.

Secondary Outcome Measures

Name	Time	Method
Themes on Patient Experiences While Undergoing RIC	up to 15 minutes	Qualitative themes related to the RIC procedure will be derived from semi-structured interviews with subjects.
Percent of Patients Recruited Who Agreed to Participate	through EMS transport, an average of 20 minutes	Participation among patients who are screened and recruited.
Timing (in Minutes) of Study Procedures	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. Screening, recruitment and RIC initiation times are overlapping with transport time.
Percent of Patients Screened Who Are Eligible for Recruitment	through EMS transport, an average of 20 minutes	Eligibility among patients screened and specifying inclusion and exclusion criteria met or not met.
Percent of Participants Experiencing Anticipated Adverse Events Including RIC Discontinuation Due to Discomfort	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 Paramedic Acceptability of the Study Protocol	up to 15 minutes from screening	Qualitative themes related to implementation of the study protocol will be derived from semi-structured interviews with study paramedics.

Trial Locations

Locations (1)

University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States