Chest PainNCT03400579
A Study of the Feasibility of Prehospital Remote Ischemic Conditioning
A study testing autoRIC® device in people with Chest Pain, run by University of North Carolina, Chapel Hill at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Chest Pain
- What is being tested?
- autoRIC® device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jul 2018to 1 Oct 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Requiring 9-1-1 response to scene
- At least 18 years of age
- Experiencing non-traumatic chest pain or anginal equivalent symptom
- Not meeting EMS criteria for a suspected STEMI based on prehospital ECG
- Systolic blood pressure (SBP) between 100-180 mgm Hg
- Designated for ambulance transport to University of North Carolina Medical Center (Chapel Hill, NC)
- Capable of providing informed consent
Who cannot join
- 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:
- Paresis of upper limb
- Pre-existing traumatic injury to arm
Show all 11Show fewer
- Presence of an arteriovenous shunt for dialysis
- Prior mastectomy
- Existing peripheral inserted central catheter line
- Arm edema or other indication of upper extremity thrombosis
- Serial ECG evidence of evolving STEMI
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
Official title: A Pilot Study of the Feasibility of Prehospital Delivery of Remote Ischemic Conditioning by Emergency Medical Services in Chest Pain Patients
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.
Read the 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
- Being tested
- autoRIC® device
- Keywords
- Emergency Medical Services
- Medical subject headings
- Chest Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autoRIC® deviceDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Remote Ischemic Conditioning | Experimental | RIC procedure (i.e., four cycles of alternating 5-min inflation and 5-min deflation) administered by the autoRIC® device Receives: Device: autoRIC® device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 40 minutes, following initiation of RIC
Secondary outcomes (6)
Percent of Patients Screened Who Are Eligible for Recruitment
Eligibility among patients screened and specifying inclusion and exclusion criteria met or not met.
Measured: through EMS transport, an average of 20 minutes
Percent of Patients Recruited Who Agreed to Participate
Participation among patients who are screened and recruited.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: up to 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2018
- Study start10 Jul 2018
- Primary completion30 Sep 2019
- Study completion1 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chest PainStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- North Carolina Translational and Clinical Sciences Institute
- Responsible party
- Sponsor
- Investigators
- Mehul D Patel, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03400579
- Sponsor's protocol ID
- 17-0287
- Other IDs
- UL1TR001111
- Status last verified
- Nov 2019
- First submitted
- 8 Jan 2018
- Last updated
- 1 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: 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.
Publications
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.
PubMed 30911405
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of the Feasibility of Prehospital Delivery of Remote Ischemic Conditioning by Emergency Medical Services in Chest Pain Patients
- ClinicalTrials.gov ID
- NCT03400579
- Acronym / sponsor ID
- 17-0287
- Conditions
- Chest Pain
- Keywords
- Emergency Medical Services
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- North Carolina Translational and Clinical Sciences Institute
- Study start
- 10 Jul 2018 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 17 Jan 2018 (actual)
- Results
- Posted 1 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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
| Arm | Type | Receives |
|---|---|---|
| Remote Ischemic Conditioning | Experimental | Device: autoRIC® deviceRIC procedure (i.e., four cycles of alternating 5-min inflation and 5-min deflation) administered by the autoRIC® device |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Requiring 9-1-1 response to scene
- At least 18 years of age
- Experiencing non-traumatic chest pain or anginal equivalent symptom
- Not meeting EMS criteria for a suspected STEMI based on prehospital ECG
- Systolic blood pressure (SBP) between 100-180 mgm Hg
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| autoRIC® deviceThe 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 | Device | Remote Ischemic Conditioning |
Primary outcome
Percent of Subjects Receiving 4 Cycles of RIC Without Interruption
Time frame: 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.
6 secondary outcomes
Percent of Patients Screened Who Are Eligible for Recruitment
Time frame: through EMS transport, an average of 20 minutes
Percent of Patients Recruited Who Agreed to Participate
Time frame: through EMS transport, an average of 20 minutes
Timing (in Minutes) of Study Procedures
Time frame: through EMS response and transport, an average of 30 minutes
Themes on Paramedic Acceptability of the Study Protocol
Time frame: up to 15 minutes from screening
Percent of Participants Experiencing Anticipated Adverse Events Including RIC Discontinuation Due to Discomfort
Time frame: up to 48 hours from end of RIC
Themes on Patient Experiences While Undergoing RIC
Time frame: up to 15 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30911405Patel 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.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mehul D Patel, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing autoRIC® device in people with Chest Pain, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of Subjects Receiving 4 Cycles of RIC Without Interruption (time frame: up to 40 minutes, following initiation of RIC). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03400579, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2020.