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| ID | Type | Description | Link |
|---|---|---|---|
| UL1TR001111 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| North Carolina Translational and Clinical Sciences Institute | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remote Ischemic Conditioning | Experimental | RIC procedure (i.e., four cycles of alternating 5-min inflation and 5-min deflation) administered by the autoRIC® device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| autoRIC® device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Percent of Patients Recruited Who Agreed to Participate |
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Inclusion Criteria:
Exclusion Criteria:
Unconscious or otherwise in critical condition
Lacking capacity to consent to the study
Non-English speaking
Pre-existing condition precluding blood pressure check or use of the autoRIC® at the discretion of the provider or listed here:
Serial ECG evidence of evolving STEMI
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| Name | Affiliation | Role |
|---|---|---|
| Mehul D Patel, PhD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30911405 | Derived | 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. |
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The researchers have no plans to make individual participant data available. Due to this study's small size and single site, individual level data will not be shared to protect the privacy of subjects and maintain the confidentiality of data. Aggregated data and results on primary and secondary outcomes will be reported on this site and published in the scientific literature.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | percentage of participants | up to 40 minutes, following initiation of RIC |
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Adverse events were collected from the time of enrollment through 48 hours after.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mehul Patel, PhD | University of North Carolina at Chapel Hill | 919-843-7307 | mehul_patel@med.unc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jun 14, 2018 | Aug 19, 2020 | Prot_SAP_ICF_001.pdf |
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| ID | Term |
|---|---|
| D002637 | Chest Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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
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Participation among patients who are screened and recruited. |
| through EMS transport, an average of 20 minutes |
| 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 |
| 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 |
| 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 |
| 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 |
| Participants |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Systolic Blood Pressure (mmHg) | Count of Participants | Participants |
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| Participants |
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| Secondary | Percent of Patients Screened Who Are Eligible for Recruitment | Eligibility among patients screened and specifying inclusion and exclusion criteria met or not met. | Includes all patients screened for study eligibility | Posted | Number | percentage of patients screened | through EMS transport, an average of 20 minutes |
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| Secondary | Percent of Patients Recruited Who Agreed to Participate | Participation among patients who are screened and recruited. | Among all patients screened and determined to be eligible | Posted | Number | percentage of patients recruited | through EMS transport, an average of 20 minutes |
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| 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. | Posted | Mean | Standard Deviation | minutes | through EMS response and transport, an average of 30 minutes |
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| 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. | 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. | Posted | Count of Participants | Participants | up to 15 minutes from screening |
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| 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. | Posted | Number | percentage of participants | up to 48 hours from end of RIC |
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| Secondary | Themes on Patient Experiences While Undergoing RIC | Qualitative themes related to the RIC procedure will be derived from semi-structured interviews with subjects. | Includes participants that completed at least two RIC cycles | Posted | Count of Participants | Participants | up to 15 minutes |
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| 10 |
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| 10 |
| 0 |
| 10 |
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| Title | Measurements |
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| Transport Time |
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| Title | Measurements |
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