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NCT Number: NCT03400579

A Study of the Feasibility of Prehospital Remote Ischemic Conditioning

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.

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Key information

Conditions

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

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Percent of Subjects Receiving 4 Cycles of RIC Without Interruption

    Time frame: up to 40 minutes, following initiation of RIC

    A completed RIC cycle without interruption is defined as 5 minutes inflation followed by 5 minutes deflation for a total of 10 minutes.

Secondary outcomes

  1. Percent of Patients Screened Who Are Eligible for Recruitment

    Time frame: through EMS transport, an average of 20 minutes

    Eligibility among patients screened and specifying inclusion and exclusion criteria met or not met.

  2. Percent of Patients Recruited Who Agreed to Participate

    Time frame: through EMS transport, an average of 20 minutes

    Participation among patients who are screened and recruited.

  3. Timing (in Minutes) of Study Procedures

    Time frame: through EMS response and transport, an average of 30 minutes

    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.

  4. Themes on Paramedic Acceptability of the Study Protocol

    Time frame: up to 15 minutes from screening

    Qualitative themes related to implementation of the study protocol will be derived from semi-structured interviews with study paramedics.

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

    Time frame: up to 48 hours from end of RIC

    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.

  6. Themes on Patient Experiences While Undergoing RIC

    Time frame: up to 15 minutes

    Qualitative themes related to the RIC procedure will be derived from semi-structured interviews with subjects.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • North Carolina Translational and Clinical Sciences Institute

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 17, 2018
Registry last updated
Sep 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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