A Study of the Feasibility of Prehospital Remote Ischemic Conditioning

NCT ID: NCT03400579

Last Updated: 2020-09-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-10
• Study Completion Date: 2019-10-01

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.

Conditions

Chest Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Remote Ischemic Conditioning

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

Group Type: EXPERIMENTAL

autoRIC® device

Intervention Type: 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

Interventions

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

North Carolina Translational and Clinical Sciences Institute

OTHER

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mehul D Patel, PhD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 30911405 (View on PubMed)

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

UL1TR001111

Identifier Type: NIH

Identifier Source: secondary_id

View Link

17-0287

Identifier Type: -

Identifier Source: org_study_id