A Study of the Feasibility of Prehospital Remote Ischemic Conditioning

NCT03400579 | Completed Results FDA Device

• 2 other identifiers: 17-0287UL1TR001111
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Chest Pain

Keywords

Emergency Medical Services

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Percent of Patients Screened Who Are Eligible for Recruitment

  through EMS transport, an average of 20 minutes

• Percent of Patients Recruited Who Agreed to Participate

  through EMS transport, an average of 20 minutes

• Timing (in Minutes) of Study Procedures

  through EMS response and transport, an average of 30 minutes

• Themes on Paramedic Acceptability of the Study Protocol

  up to 15 minutes from screening

• Percent of Participants Experiencing Anticipated Adverse Events Including RIC Discontinuation Due to Discomfort

  up to 48 hours from end of RIC

Study Arms (1)

Remote Ischemic Conditioning

EXPERIMENTAL

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

Device: autoRIC® device

Interventions

autoRIC® device 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

Remote Ischemic Conditioning

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• North Carolina Translational and Clinical Sciences Institute: collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (1)

• 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.

  PMID: 30911405 DERIVED

MeSH Terms

Conditions

Chest Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Mehul Patel, PhD
• Organization: University of North Carolina at Chapel Hill

mehul_patel@med.unc.edu

919-843-7307

Study Officials

• Mehul D Patel, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, single center, single arm pilot study evaluating the feasibility of delivering remote ischemic conditioning by emergency medical services during ground ambulance transport of patients experiencing chest pain or anginal equivalent symptom

Study Record Dates

• First Submitted: January 8, 2018
• First Posted: January 17, 2018
• Study Start: July 10, 2018
• Primary Completion: September 30, 2019
• Study Completion: October 1, 2019
• Last Updated: September 1, 2020
• Results First Posted: September 1, 2020

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)