Revascularization StrategIes for ST Elevation Myocardial Infarction Trial (ASSIST-MI)

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.

Study Overview

• Status: Unknown
• Conditions: ST Elevation Myocardial Infarction; Coronary Stenting; Primary Angioplasty
• Intervention / Treatment: Procedure: Same sitting PCI with complete revascularization; Procedure: Staged PCI with complete revsacularization >48 hours pf primary PCI

• Study Type: Interventional
• Enrollment (Anticipated): 3520
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Same sitting complete revascularization; After treatment of the IRA, subjects will undergo PCI of all suitable significant non-IRA lesions (≥70% by visual assessment or FFR<0.80 in 50-70% lesions with vessel diameter >2mm).	Procedure: Same sitting PCI with complete revascularization; revascualrization of the non IRA (infarct related artery) of > 2.0 mm by coronary angioplasty/stenting at the time of primary PCI
ACTIVE_COMPARATOR: Staged non-IRA PCI; Only the IRA will be intervened upon during the index primary PCI procedure. Staging of the non-IRA lesions will be performed 48 hours to 45 days after the primary PCI procedure. All suitable non-IRA lesions (≥70% by visual assessment or FFR<0.80 in 50-70% lesions with vessel diameter >2mm) will be treated with PCI irrespective of whether there are clinical symptoms or evidence of ischemia.	Procedure: Staged PCI with complete revsacularization >48 hours pf primary PCI; revascualrization of the non IRA (infarct related artery) of > 2.0 mm by coronary angioplasty/stenting >48 hours to 45 days post primary PCI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major adverse clinical events	Composite of all-cause mortality, myocardial infarction, heart failure and unplanned revascularization	90 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Unity Health Toronto
• Investigators: Principal Investigator: Akshay Bagai, MD, Unity Health Toronto

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 1, 2017
• Primary Completion (ANTICIPATED): December 31, 2020
• Study Completion (ANTICIPATED): December 31, 2021

Study Registration Dates

• First Submitted: August 23, 2017
• First Submitted That Met QC Criteria: August 25, 2017
• First Posted (ACTUAL): August 28, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 28, 2017
• Last Update Submitted That Met QC Criteria: August 25, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; ST Elevation Myocardial Infarction
• Other Study ID Numbers: 17-254

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No