Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1622 participants
INTERVENTIONAL
2016-07-04
2019-07-26
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
OTHER
NONE
Study Groups
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'Before' group
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.
No interventions assigned to this group
'After' group
Patients who underwent primary PCI for STEMI after implementation of the RIC protocol. These patients were treated with the autoRIC device prior to PCI.
autoRIC
Application of the autoRIC device
Interventions
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autoRIC
Application of the autoRIC device
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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).
18 Years
ALL
No
Sponsors
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Sunnybrook Health Sciences Centre
OTHER
Trillium Health Centre
OTHER
Peel Regional Paramedic Service
UNKNOWN
Halton Region Paramedic Services
OTHER
CellAegis US, Inc.
INDUSTRY
William Osler Health System
OTHER
Responsible Party
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Dr. Sheldon Cheskes
Medical Director
Locations
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Brampton Civic Hospital
Brampton, Ontario, Canada
The Mississauga Hospital
Mississauga, Ontario, Canada
Countries
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Other Identifiers
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16-0008
Identifier Type: -
Identifier Source: org_study_id
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