Revascularization StrategIes for ST Elevation Myocardial Infarction Trial

ST Elevation Myocardial Infarction Clinical Trial

— ASSIST-MI  

Official title:

Revascularization StrategIes for ST Elevation Myocardial Infarction Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03263468
• Other study ID #: 17-254
• Status: Not yet recruiting
• Phase: N/A
• First received: August 23, 2017
• Last updated: August 25, 2017
• Start date: September 1, 2017
• Est. completion date: December 31, 2021

Study information

• Verified date: August 2017
• Source: St. Michael's Hospital, Toronto
• Contact: Val Panzov
• Phone: 416-864-6060
• Email: panzovv[@]smh.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 3520
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Stenting
• Infarction
• Myocardial Infarction
• Primary Angioplasty
• ST Elevation Myocardial Infarction

Intervention

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
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
St. Michael's Hospital, Toronto

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major adverse clinical events	Composite of all-cause mortality, myocardial infarction, heart failure and unplanned revascularization	90 days
Secondary	Major bleeding		90 days
Secondary	Stroke		90 days
Secondary	Contrast nephropathy		90 days
Secondary	Major vascular complication		90 days
Secondary	EQ-5D quality of life assessment		90 days
Secondary	Incremental Cost-Effectiveness Ratio (ICER)		90 days
Secondary	Myocardial infarction		90 days
Secondary	Heart failure		90 days
Secondary	All cause mortality		90 days
Secondary	Unplanned revascularization		90 days