Field Implementation of the autoRIC Device in STEMI

ST Elevation Myocardial Infarction Clinical Trial

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Official title:

Field Implementation of the autoRIC Device in STEMI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03265067
• Other study ID #: 16-0008
• Status: Completed
• Phase: N/A
• Start date: July 4, 2016
• Est. completion date: July 26, 2019

Study information

• Verified date: October 2019
• Source: William Osler Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1622
• Est. completion date: July 26, 2019
• Est. primary completion date: July 26, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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).

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction

Intervention

Device:
• autoRIC
Application of the autoRIC device

Locations

Country	Name	City	State
Canada	Brampton Civic Hospital	Brampton	Ontario
Canada	The Mississauga Hospital	Mississauga	Ontario

Sponsors (6)

Lead Sponsor	Collaborator
William Osler Health System	CellAegis US, Inc., Halton Region Paramedic Services, Peel Regional Paramedic Service, Sunnybrook Health Sciences Centre, Trillium Health Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	90-day MACCE	Major adverse cardiovascular and cerebrovascular events (MACCE) in-hospital and within 90 days of PCI.	Within 90 days of PCI
Secondary	30, 60 and 180-day MACCE	MACCE within 30, 60 and 180 days post hospital admission	Within 30, 60 and 180 days of admission
Secondary	LOS	Index hospitalization length of stay (LOS)	Time from hospital admission to hospital discharge, up to 180 days of admission
Secondary	Cardiovascular-related death	Death due to cardiovascular related events	Time from hospital admission to hospital discharge, up to 180 days of admission
Secondary	30, 60, and 180-day cardiovascular-related readmission	Hospital readmission within 30, 60, and 180 days of index hospitalization, due to cardiovascular events.	30, 60 and 180 days after index hospitalization
Secondary	Infarct size	Size of infarct as measured by peak troponin level during index event admission	Time from hospital admission to hospital discharge, up to 180 days of admission