Trial Outcomes & Findings for A Study of the Feasibility of Prehospital Remote Ischemic Conditioning (NCT NCT03400579)

Last Updated: 2020-09-01

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

10 participants

Primary outcome timeframe

up to 40 minutes, following initiation of RIC

Results posted on

2020-09-01

Participant Flow

Participant milestones

Participant milestones
Measure	Remote Ischemic Conditioning RIC procedure (i.e., four cycles of alternating 5-min inflation and 5-min deflation) administered by the autoRIC® 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
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of the Feasibility of Prehospital Remote Ischemic Conditioning

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Remote Ischemic Conditioning n=10 Participants RIC procedure (i.e., four cycles of alternating 5-min inflation and 5-min deflation) administered by the autoRIC® 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
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex/Gender, Customized Female	8 Participants n=5 Participants
Sex/Gender, Customized Male	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	10 Participants n=5 Participants
Systolic Blood Pressure (mmHg) 100-120	3 Participants n=5 Participants
Systolic Blood Pressure (mmHg) 121-140	2 Participants n=5 Participants
Systolic Blood Pressure (mmHg) 141-160	4 Participants n=5 Participants
Systolic Blood Pressure (mmHg) 161-180	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Remote Ischemic Conditioning n=10 Participants RIC procedure (i.e., four cycles of alternating 5-min inflation and 5-min deflation) administered by the autoRIC® 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
Percent of Subjects Receiving 4 Cycles of RIC Without Interruption	80 percentage of participants

SECONDARY outcome

Timeframe: through EMS transport, an average of 20 minutes

Population: Includes all patients screened for study eligibility

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

Outcome measures

Outcome measures
Measure	Remote Ischemic Conditioning n=11 Participants RIC procedure (i.e., four cycles of alternating 5-min inflation and 5-min deflation) administered by the autoRIC® 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
Percent of Patients Screened Who Are Eligible for Recruitment	100 percentage of patients screened

SECONDARY outcome

Timeframe: through EMS transport, an average of 20 minutes

Population: Among all patients screened and determined to be eligible

Participation among patients who are screened and recruited.

Outcome measures

Outcome measures
Measure	Remote Ischemic Conditioning n=11 Participants RIC procedure (i.e., four cycles of alternating 5-min inflation and 5-min deflation) administered by the autoRIC® 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
Percent of Patients Recruited Who Agreed to Participate	91 percentage of patients recruited

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Remote Ischemic Conditioning n=10 Participants RIC procedure (i.e., four cycles of alternating 5-min inflation and 5-min deflation) administered by the autoRIC® 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
Timing (in Minutes) of Study Procedures On-Scene Time	22.5 minutes Standard Deviation 5.6
Timing (in Minutes) of Study Procedures Screening Time	9.4 minutes Standard Deviation 10.0
Timing (in Minutes) of Study Procedures Recruitment and RIC Start Time	4.4 minutes Standard Deviation 8.7
Timing (in Minutes) of Study Procedures Transport Time	9.2 minutes Standard Deviation 4.6

SECONDARY outcome

Timeframe: up to 15 minutes from screening

Population: The overall number of participants analyzed reflects participants undergoing the intervention (i.e., "Remote Ischemic Conditioning"). The study paramedics administering the intervention were not considered enrolled but contributed data for this assessment.

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

Outcome measures

Outcome measures
Measure	Remote Ischemic Conditioning n=10 Participants RIC procedure (i.e., four cycles of alternating 5-min inflation and 5-min deflation) administered by the autoRIC® 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
Themes on Paramedic Acceptability of the Study Protocol Not enough time	4 Participants
Themes on Paramedic Acceptability of the Study Protocol Difficult to size the cuff	4 Participants
Themes on Paramedic Acceptability of the Study Protocol Ongoing training needed	3 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Remote Ischemic Conditioning n=10 Participants RIC procedure (i.e., four cycles of alternating 5-min inflation and 5-min deflation) administered by the autoRIC® 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
Percent of Participants Experiencing Anticipated Adverse Events Including RIC Discontinuation Due to Discomfort	0 percentage of participants

SECONDARY outcome

Timeframe: up to 15 minutes

Population: Includes participants that completed at least two RIC cycles

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

Outcome measures

Outcome measures
Measure	Remote Ischemic Conditioning n=9 Participants RIC procedure (i.e., four cycles of alternating 5-min inflation and 5-min deflation) administered by the autoRIC® 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
Themes on Patient Experiences While Undergoing RIC Felt like a blood pressure cuff	5 Participants
Themes on Patient Experiences While Undergoing RIC Felt tight	4 Participants

Adverse Events

Remote Ischemic Conditioning

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mehul Patel, PhD

University of North Carolina at Chapel Hill

Phone: 919-843-7307

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place