Revascularization StrategIes for ST Elevation Myocardial Infarction Trial

Not Applicable

• Conditions: Primary Angioplasty; Coronary Stenting; ST Elevation Myocardial Infarction

• Registration Number: NCT03263468
• Lead Sponsor: Unity Health Toronto

Brief Summary

This study is being conducted in patients with a major heart attack caused by a blocked artery undergoing Percutaneous Coronary Intervention (PCI) to open up the blockage. Up to 50% of people with an heart attack are found to have one or more additional narrowings that did not cause the heart attack. At present the best way to manage these additional blockages is not known. Many cardiologist recommend opening these blockages at at a later time after the heart attack. The present study is examining if PCI of all blockages at the same time as the PCI for the artery that caused the major heart attack (SS-PCI) will reduce the amount of heart damage compared to performing PCI of additional blockages 2-45 days later (IRA-PCI). Clinical follow up will be completed at 3, 12 and 24 months to determine heart function and monitor adverse events.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-08
• Study First Submitted: 2017-08-23
• Study First Submitted QC: 2017-08-25
• Last Update Submitted: 2017-08-25
• Study First Posted: 2017-08-28
• Last Update Posted: 2017-08-28
• Study Start: 2017-09-01
• Primary Completion: 2020-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 3520

Inclusion Criteria

• ST elevation myocardial infarction evidenced by new ST elevation at the J point in at least 2 contiguous leads of ≥ 2 mm (0.2mV) in men or ≥ 1.5mm (0.15mV) in women in leads V2-V3 and/or ≥ 1mm (0.1mV) in other contiguous chest leads or limb leads.
• MVD as evidenced by > one significant (>70% by visual assessment or FFR < 0.80 for 50-70% stenosis) stenosis in the non-IRA >2mm in diameter.
• Successful IRA-PCI with <30% residual angiographic stenosis and TIMI III flow
• Written informed consent

Exclusion Criteria

• Age ≤ 18 years
• Prior coronary artery bypass graft (CABG) surgery
• Administration of thrombolytic therapy.
• Hemodynamic instability as evidenced by SBP<90 mmHg, Killip class ≥3, and/or need for inotropes/vasopressors.
• Known renal insufficiency (estimated GFR < 30 ml/min/1.73m2)
• Non-IRA stenosis is a chronic total occlusion (CTO)
• Plan by treating physician to treat non-IRA stenosis with coronary artery bypass surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Major adverse clinical events	90 days	Composite of all-cause mortality, myocardial infarction, heart failure and unplanned revascularization

Secondary Outcome Measures

Name	Time	Method
Major bleeding	90 days
Stroke	90 days
Contrast nephropathy	90 days
Major vascular complication	90 days
EQ-5D quality of life assessment	90 days
Myocardial infarction	90 days
All cause mortality	90 days
Unplanned revascularization	90 days
Heart failure	90 days
Incremental Cost-Effectiveness Ratio (ICER)	90 days