ST Elevation Myocardial InfarctionFIRSTNCT03265067
Field Implementation of the autoRIC Device in STEMI
A study testing autoRIC in people with ST Elevation Myocardial Infarction, run by William Osler Health System at 2 sites in Canada.
Trial summary
This is a "before and after" observational study of a therapeutic strategy to treat patients with confirmed ST-segment myocardial infarction (STEMI) with remote ischemic conditioning (RIC) before undergoing primary percutaneous coronary intervention (PCI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ST Elevation Myocardial Infarction
- What is being tested?
- autoRIC
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,622 participants
- Where
- 2 sitesCanada
- Study dates
- 4 Jul 2016to 26 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age and older;
- patients diagnosed with STEMI in the prehospital environment by responding paramedics from Peel Regional Paramedic Services or Halton Emergency Medical Service and transported to the PCI laboratory of Brampton Civic Hospital or Trillium Health Partners;
- walk-in patients diagnosed with STEMI in the ED of either of these two facilities.
Who cannot join
- left-bundle branch block;
- Lymphedema on either arm
- PICC Line on either arm
- AV fistula or no palpable pulse on either arm;
- patient has a known bleeding disorder or known abnormality of blood flow to the left arm;
- patient has peripheral nerve injury, abnormal nerve supply, peripheral neuropathy or pre- existing traumatic injury to the limb to be treated (left-arm).
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Brampton Civic Hospital
Brampton, Ontario, L6R 3J7
The Mississauga Hospital
Mississauga, Ontario, L5B 1B8
About this study
This is a "before and after" observational study of a therapeutic strategy to treat patients with confirmed ST-segment myocardial infarction (STEMI) with remote ischemic conditioning (RIC) before undergoing primary percutaneous coronary intervention (PCI). RIC is the purposeful application of brief, intermittent cycles of limb occlusion by inflation/deflation of a pneumatic cuff. The autoRIC device is an automatic RIC delivery device (the autoRIC® Device; CellAegis Devices Inc, Toronto, ON) that has received clearance from Health Canada for this use under the direction of a health care professional. Paramedics in the Peel and Halton regional emergency services and the Emergency department (ED) staff of Brampton Civic Hospital and Mississauga Hospital will treat patients experiencing STEMI with autoRIC, and study data will be collected from existing patient records.
The 'before' group will include up to 900 patients who were treated before autoRIC implementation in the services and hospitals. These patients would have had a STEMI and undergone PCI, but did not receive the autoRIC device. The 'after' group will include up to 900 eligible patients who have had RIC treatment with the autoRIC device at the two participating sites following implementation in the services and hospitals.
The primary analyses will compare the short-term and long-term outcomes of eligible patients who have received completed primary PCI for STEMI in the time period before the implementation and following the implementation of this RIC strategy. In addition, a health economic analysis will be conducted to determine the cost-effectiveness of the therapeutic strategy to treat STEMI patients with RIC prior to PCI.
- Conditions
- ST Elevation Myocardial Infarction
- Being tested
- autoRIC
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autoRICDevice
Application of the autoRIC device
| Study group | Role | What they receive |
|---|---|---|
| 'Before' group | No intervention | Patients who underwent primary PCI for STEMI prior to implementation of the RIC protol. These patients were not treated with the autoRIC device prior to PCI. |
| 'After' group | Experimental | Patients who underwent primary PCI for STEMI after implementation of the RIC protocol. These patients were treated with the autoRIC device prior to PCI. Receives: Device: autoRIC |
What is being measured
The primary outcome is the main question the study is designed to answer.
90-day MACCE
Major adverse cardiovascular and cerebrovascular events (MACCE) in-hospital and within 90 days of PCI.
Measured: Within 90 days of PCI
Secondary outcomes (5)
30, 60 and 180-day MACCE
MACCE within 30, 60 and 180 days post hospital admission
Measured: Within 30, 60 and 180 days of admission
LOS
Index hospitalization length of stay (LOS)
Measured: Time from hospital admission to hospital discharge, up to 180 days of admission
Cardiovascular-related death
Death due to cardiovascular related events
Measured: Time from hospital admission to hospital discharge, up to 180 days of admission
30, 60, and 180-day cardiovascular-related readmission
Hospital readmission within 30, 60, and 180 days of index hospitalization, due to cardiovascular events.
Measured: 30, 60 and 180 days after index hospitalization
Infarct size
Size of infarct as measured by peak troponin level during index event admission
Measured: Time from hospital admission to hospital discharge, up to 180 days of admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2017
- Study start4 Jul 2016
- Primary completion26 Jul 2019
- Study completion26 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ST Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Sequential
- Model description
- Before and after phase study
- Masking
- None (open label)
- Enrolment
- 1,622 participants (actual)
Sponsor and investigators
- Lead sponsor
- William Osler Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Sunnybrook Health Sciences Centre, Trillium Health Centre, Peel Regional Paramedic Service, Halton Region Paramedic Services, CellAegis US, Inc.
- Responsible party
- Principal investigator, Dr. Sheldon Cheskes, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03265067
- Sponsor's protocol ID
- 16-0008
- Acronym
- FIRST
- Status last verified
- Oct 2019
- First submitted
- 21 Aug 2017
- Last updated
- 2 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Field Implementation of the autoRIC Device in STEMI
- ClinicalTrials.gov ID
- NCT03265067
- Acronym / sponsor ID
- FIRST / 16-0008
- Conditions
- ST Elevation Myocardial Infarction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,622 participants (actual)
- Lead sponsor
- William Osler Health SystemUniversity, hospital or other
- Collaborators
- Sunnybrook Health Sciences Centre, Trillium Health Centre, Peel Regional Paramedic Service, Halton Region Paramedic Services, CellAegis US, Inc.
- Study start
- 4 Jul 2016 (actual)
- Primary completion
- 26 Jul 2019 (actual)
- Study completion
- 26 Jul 2019 (actual)
- First posted
- 29 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a "before and after" observational study of a therapeutic strategy to treat patients with confirmed ST-segment myocardial infarction (STEMI) with remote ischemic conditioning (RIC) before undergoing primary percutaneous coronary intervention (PCI). RIC is the purposeful application of brief, intermittent cycles of limb occlusion by inflation/deflation of a pneumatic cuff. The autoRIC device is an automatic RIC delivery device (the autoRIC® Device; CellAegis Devices Inc, Toronto, ON) that has received clearance from Health Canada for this use under the direction of a health care professional. Paramedics in the Peel and Halton regional emergency services and the Emergency department (ED) staff of Brampton Civic Hospital and Mississauga Hospital will treat patients experiencing STEMI with autoRIC, and study data will be collected from existing patient records.
The 'before' group will include up to 900 patients who were treated before autoRIC implementation in the services and hospitals. These patients would have had a STEMI and undergone PCI, but did not receive the autoRIC device. The 'after' group will include up to 900 eligible patients who have had RIC treatment with the autoRIC device at the two participating sites following implementation in the services and hospitals.
The primary analyses will compare the short-term and long-term outcomes of eligible patients who have received completed primary PCI for STEMI in the time period before the implementation and following the implementation of this RIC strategy. In addition, a health economic analysis will be conducted to determine the cost-effectiveness of the therapeutic strategy to treat STEMI patients with RIC prior to PCI.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Before and after phase study
| Arm | Type | Receives |
|---|---|---|
| 'Before' group | No intervention | –Patients who underwent primary PCI for STEMI prior to implementation of the RIC protol. These patients were not treated with the autoRIC device prior to PCI. |
| 'After' group | Experimental | Device: autoRICPatients who underwent primary PCI for STEMI after implementation of the RIC protocol. These patients were treated with the autoRIC device prior to PCI. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age and older;
- patients diagnosed with STEMI in the prehospital environment by responding paramedics from Peel Regional Paramedic Services or Halton Emergency Medical Service and transported to the PCI laboratory of Brampton Civic Hospital or Trillium Health Partners;
- walk-in patients diagnosed with STEMI in the ED of either of these two facilities.
Key exclusion criteria (6 listed)
- left-bundle branch block;
- Lymphedema on either arm
- PICC Line on either arm
- AV fistula or no palpable pulse on either arm;
- patient has a known bleeding disorder or known abnormality of blood flow to the left arm;
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 |
|---|---|---|
| autoRICApplication of the autoRIC device | Device | 'After' group |
Primary outcome
90-day MACCE
Time frame: Within 90 days of PCI
Major adverse cardiovascular and cerebrovascular events (MACCE) in-hospital and within 90 days of PCI.
5 secondary outcomes
30, 60 and 180-day MACCE
Time frame: Within 30, 60 and 180 days of admission
LOS
Time frame: Time from hospital admission to hospital discharge, up to 180 days of admission
Cardiovascular-related death
Time frame: Time from hospital admission to hospital discharge, up to 180 days of admission
30, 60, and 180-day cardiovascular-related readmission
Time frame: 30, 60 and 180 days after index hospitalization
Infarct size
Time frame: Time from hospital admission to hospital discharge, up to 180 days of admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing autoRIC in people with ST Elevation Myocardial Infarction, run by William Osler Health System at 2 sites in Canada.
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 3 inclusion and 6 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 2 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
90-day MACCE (time frame: Within 90 days of PCI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Oct 2019.