A Study of the Feasibility of Prehospital Remote Ischemic Conditioning

University of North Carolina (UNC)

Status: Completed

Conditions: Chest Pain

Treatments: Device: autoRIC® device

Study type: Interventional

Funder types: Other

Identifiers

NCT03400579

17-0287

UL1TR001111 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Remote Ischemic Conditioning

Experimental group

Description:

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

Treatment:

Device: autoRIC® device