A Study of the Feasibility of Prehospital Remote Ischemic Conditioning

A Pilot Study of the Feasibility of Prehospital Delivery of Remote Ischemic Conditioning by Emergency Medical Services in Chest Pain Patients

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.

Study Overview

• Status: Completed
• Conditions: Chest Pain
• Intervention / Treatment: Device: autoRIC® device

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina at Chapel Hill

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of Subjects Receiving 4 Cycles of RIC Without Interruption	A completed RIC cycle without interruption is defined as 5 minutes inflation followed by 5 minutes deflation for a total of 10 minutes.	up to 40 minutes, following initiation of RIC

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of Patients Screened Who Are Eligible for Recruitment	Eligibility among patients screened and specifying inclusion and exclusion criteria met or not met.	through EMS transport, an average of 20 minutes
Percent of Patients Recruited Who Agreed to Participate	Participation among patients who are screened and recruited.	through EMS transport, an average of 20 minutes
Timing (in Minutes) of Study Procedures	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.	through EMS response and transport, an average of 30 minutes
Themes on Paramedic Acceptability of the Study Protocol	Qualitative themes related to implementation of the study protocol will be derived from semi-structured interviews with study paramedics.	up to 15 minutes from screening
Percent of Participants Experiencing Anticipated Adverse Events Including RIC Discontinuation Due to Discomfort	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.	up to 48 hours from end of RIC
Themes on Patient Experiences While Undergoing RIC	Qualitative themes related to the RIC procedure will be derived from semi-structured interviews with subjects.	up to 15 minutes

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: North Carolina Translational and Clinical Sciences Institute
• Investigators: Principal Investigator: Mehul D Patel, PhD, University of North Carolina, Chapel Hill

Publications and helpful links

General Publications

• Patel MD, Platts-Mills TF, Grover JM, Thomas SM, Rossi JS. Feasibility of prehospital delivery of remote ischemic conditioning by emergency medical services in chest pain patients: protocol for a pilot study. Pilot Feasibility Stud. 2019 Mar 13;5:42. doi: 10.1186/s40814-019-0431-8. eCollection 2019.

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2018
• Primary Completion (Actual): September 30, 2019
• Study Completion (Actual): October 1, 2019

Study Registration Dates

• First Submitted: January 8, 2018
• First Submitted That Met QC Criteria: January 12, 2018
• First Posted (Actual): January 17, 2018

Study Record Updates

• Last Update Posted (Actual): September 1, 2020
• Last Update Submitted That Met QC Criteria: August 19, 2020
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Emergency Medical Services
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chest Pain
• Other Study ID Numbers: 17-0287; UL1TR001111 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: The researchers have no plans to make individual participant data available. Due to this study's small size and single site, individual level data will not be shared to protect the privacy of subjects and maintain the confidentiality of data. Aggregated data and results on primary and secondary outcomes will be reported on this site and published in the scientific literature.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No