A Study of the Feasibility of Prehospital Remote Ischemic Conditioning

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.

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