A Study of the Feasibility of Prehospital Remote Ischemic Conditioning

Chest Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03400579
• Other study ID #: 17-0287
• Secondary ID: UL1TR001111
• Status: Completed
• Phase: N/A
• Start date: July 10, 2018
• Est. completion date: October 1, 2019

Study information

• Verified date: November 2019
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: October 1, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Chest Pain

Intervention

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

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	North Carolina Translational and Clinical Sciences Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percent of Patients Screened Who Are Eligible for Recruitment	Eligibility among patients screened and specifying inclusion and exclusion criteria met or not met.	through EMS transport, an average of 20 minutes
Secondary	Percent of Patients Recruited Who Agreed to Participate	Participation among patients who are screened and recruited.	through EMS transport, an average of 20 minutes
Secondary	Timing (in Minutes) of Study Procedures	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.	through EMS response and transport, an average of 30 minutes
Secondary	Themes on Paramedic Acceptability of the Study Protocol	Qualitative themes related to implementation of the study protocol will be derived from semi-structured interviews with study paramedics.	up to 15 minutes from screening
Secondary	Percent of Participants Experiencing Anticipated Adverse Events Including RIC Discontinuation Due to Discomfort	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.	up to 48 hours from end of RIC
Secondary	Themes on Patient Experiences While Undergoing RIC	Qualitative themes related to the RIC procedure will be derived from semi-structured interviews with subjects.	up to 15 minutes