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A Study of the Feasibility of Prehospital Remote Ischemic Conditioning

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03400579
Recruitment Status : Completed
First Posted : January 17, 2018
Last Update Posted : November 14, 2019
Sponsor:
Collaborator:
North Carolina Translational and Clinical Sciences Institute
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

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.

Condition or disease Intervention/treatment Phase
Chest Pain Device: autoRIC® device Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: 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
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Pilot Study of the Feasibility of Prehospital Delivery of Remote Ischemic Conditioning by Emergency Medical Services in Chest Pain Patients
Actual Study Start Date : July 10, 2018
Actual Primary Completion Date : September 30, 2019
Actual Study Completion Date : October 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Remote Ischemic Conditioning
RIC procedure (i.e., four cycles of alternating 5-min inflation and 5-min deflation) administered by the autoRIC® device
Device: autoRIC® 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 Outcome Measures :
  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 Outcome Measures :
  1. Percent of patients screened who are eligible for recruitment [ Time Frame: through EMS transport, an average of 20 minutes ]
    Eligibility rates 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 rates 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.

  4. Themes on paramedic acceptability of the study protocol [ Time Frame: up to 15 minutes ]
    Qualitative themes related to implementation of the study protocol will be derived from semi-structured interviews with study paramedics.

  5. Percent of patients 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03400579


Locations
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United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
North Carolina Translational and Clinical Sciences Institute
Investigators
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Principal Investigator: Mehul D Patel, PhD University of North Carolina, Chapel Hill
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT03400579    
Other Study ID Numbers: 17-0287
UL1TR001111 ( U.S. NIH Grant/Contract )
First Posted: January 17, 2018    Key Record Dates
Last Update Posted: November 14, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The researchers have no plans to make individual participant data available. Due to this study's small size and single site, individual level data will not be shared to protect the privacy of subjects and maintain the confidentiality of data. Aggregated data and results on primary and secondary outcomes will be reported on this site and published in the scientific literature.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by University of North Carolina, Chapel Hill:
Emergency Medical Services
Additional relevant MeSH terms:
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Chest Pain
Pain
Neurologic Manifestations
Signs and Symptoms