N/A N=10 Other

A Study of the Feasibility of Prehospital Remote Ischemic Conditioning

Chest Pain

Bottom Line

View on ClinicalTrials.gov: NCT03400579 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2020

Primary outcome: Primary: Percent of Subjects Receiving 4 Cycles of RIC Without Interruption — 80 percentage of participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: autoRIC® device (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of North Carolina, Chapel Hill
Primary completion: Sep 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent of Subjects Receiving 4 Cycles of RIC Without Interruption	80	—
SECONDARY Percent of Patients Screened Who Are Eligible for Recruitment	100	—
SECONDARY Percent of Patients Recruited Who Agreed to Participate	91	—
SECONDARY Timing (in Minutes) of Study Procedures	22.5; 9.4; 4.4; 9.2	—
SECONDARY Themes on Paramedic Acceptability of the Study Protocol	4; 4; 3	—
SECONDARY Percent of Participants Experiencing Anticipated Adverse Events Including RIC Discontinuation Due to Discomfort	—	—
SECONDARY Themes on Patient Experiences While Undergoing RIC	5; 4	—

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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

Unconscious or otherwise in critical condition
Lacking capacity to consent to the study
Non-English speaking
Pre-existing condition precluding blood pressure check or use of the autoRIC® at the discretion of the provider or listed here:
Paresis of upper limb
Pre-existing traumatic injury to arm
Presence of an arteriovenous shunt for dialysis
Prior mastectomy
Existing peripheral inserted central catheter line
Arm edema or other indication of upper extremity thrombosis
Serial ECG evidence of evolving STEMI

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03400579). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.