Chest Pain
Conditions
Keywords
Emergency Medical Services
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.
Interventions
DEVICEautoRIC® 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
Sponsors
North Carolina Translational and Clinical Sciences Institute
University of North Carolina, Chapel Hill
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
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
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Subjects Receiving 4 Cycles of RIC Without Interruption | 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
| Measure | Time frame | Description |
|---|---|---|
| Percent of Patients Recruited Who Agreed to Participate | through EMS transport, an average of 20 minutes | Participation among patients who are screened and recruited. |
| Timing (in Minutes) of Study Procedures | 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. |
| Percent of Patients Screened Who Are Eligible for Recruitment | through EMS transport, an average of 20 minutes | Eligibility among patients screened and specifying inclusion and exclusion criteria met or not met. |
| Percent of Participants Experiencing Anticipated Adverse Events Including RIC Discontinuation Due to Discomfort | 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. |
| Themes on Patient Experiences While Undergoing RIC | up to 15 minutes | Qualitative themes related to the RIC procedure will be derived from semi-structured interviews with subjects. |
| Themes on Paramedic Acceptability of the Study Protocol | up to 15 minutes from screening | Qualitative themes related to implementation of the study protocol will be derived from semi-structured interviews with study paramedics. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Remote Ischemic Conditioning |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 4 Participants |
| Region of Enrollment United States | 10 Participants |
| Sex/Gender, Customized Female | 8 Participants |
| Sex/Gender, Customized Male | 2 Participants |
| Systolic Blood Pressure (mmHg) 100-120 | 3 Participants |
| Systolic Blood Pressure (mmHg) 121-140 | 2 Participants |
| Systolic Blood Pressure (mmHg) 141-160 | 4 Participants |
| Systolic Blood Pressure (mmHg) 161-180 | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
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.
Time frame: up to 40 minutes, following initiation of RIC
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Remote Ischemic Conditioning | Percent of Subjects Receiving 4 Cycles of RIC Without Interruption | 80 percentage of participants |
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.
Time frame: up to 48 hours from end of RIC
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Remote Ischemic Conditioning | Percent of Participants Experiencing Anticipated Adverse Events Including RIC Discontinuation Due to Discomfort | 0 percentage of participants |
Secondary
Percent of Patients Recruited Who Agreed to Participate
Participation among patients who are screened and recruited.
Time frame: through EMS transport, an average of 20 minutes
Population: Among all patients screened and determined to be eligible
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Remote Ischemic Conditioning | Percent of Patients Recruited Who Agreed to Participate | 91 percentage of patients recruited |
Secondary
Percent of Patients Screened Who Are Eligible for Recruitment
Eligibility among patients screened and specifying inclusion and exclusion criteria met or not met.
Time frame: through EMS transport, an average of 20 minutes
Population: Includes all patients screened for study eligibility
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Remote Ischemic Conditioning | Percent of Patients Screened Who Are Eligible for Recruitment | 100 percentage of patients screened |
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.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Remote Ischemic Conditioning | Themes on Paramedic Acceptability of the Study Protocol | Not enough time | 4 Participants |
| Remote Ischemic Conditioning | Themes on Paramedic Acceptability of the Study Protocol | Difficult to size the cuff | 4 Participants |
| Remote Ischemic Conditioning | Themes on Paramedic Acceptability of the Study Protocol | Ongoing training needed | 3 Participants |
Secondary
Themes on Patient Experiences While Undergoing RIC
Qualitative themes related to the RIC procedure will be derived from semi-structured interviews with subjects.
Time frame: up to 15 minutes
Population: Includes participants that completed at least two RIC cycles
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Remote Ischemic Conditioning | Themes on Patient Experiences While Undergoing RIC | Felt like a blood pressure cuff | 5 Participants |
| Remote Ischemic Conditioning | Themes on Patient Experiences While Undergoing RIC | Felt tight | 4 Participants |
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.
Time frame: through EMS response and transport, an average of 30 minutes
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Remote Ischemic Conditioning | Timing (in Minutes) of Study Procedures | On-Scene Time | 22.5 minutes | Standard Deviation 5.6 |
| Remote Ischemic Conditioning | Timing (in Minutes) of Study Procedures | Screening Time | 9.4 minutes | Standard Deviation 10 |
| Remote Ischemic Conditioning | Timing (in Minutes) of Study Procedures | Recruitment and RIC Start Time | 4.4 minutes | Standard Deviation 8.7 |
| Remote Ischemic Conditioning | Timing (in Minutes) of Study Procedures | Transport Time | 9.2 minutes | Standard Deviation 4.6 |