Clinical trial NCT03400579: A Study of the Feasibility of Prehospital Remote Ischemic Conditioning
Official title: A Pilot Study of the Feasibility of Prehospital Delivery of Remote Ischemic Conditioning by Emergency Medical Services in Chest Pain Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chest Pain
Keywords: Emergency Medical Services
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: North Carolina Translational and Clinical Sciences Institute
First posted: 2018-01-17
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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
Primary purpose: OTHER

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.

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.

Eligibility 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

Primary outcomes:
measure: Percent of Subjects Receiving 4 Cycles of RIC Without Interruption
timeFrame: up to 40 minutes, following initiation of RIC
Secondary outcomes:
measure: Percent of Patients Screened Who Are Eligible for Recruitment
timeFrame: through EMS transport, an average of 20 minutes
measure: Percent of Patients Recruited Who Agreed to Participate
timeFrame: through EMS transport, an average of 20 minutes
measure: Timing (in Minutes) of Study Procedures
timeFrame: through EMS response and transport, an average of 30 minutes
measure: Themes on Paramedic Acceptability of the Study Protocol
timeFrame: up to 15 minutes from screening
measure: Percent of Participants Experiencing Anticipated Adverse Events Including RIC Discontinuation Due to Discomfort
timeFrame: up to 48 hours from end of RIC
measure: Themes on Patient Experiences While Undergoing RIC
timeFrame: up to 15 minutes
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Mehul D Patel, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.