Revascularization StrategIes for ST Elevation Myocardial Infarction Trial

NCT ID: NCT03263468

Last Updated: 2017-08-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 3520 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-01
• Study Completion Date: 2021-12-31

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.

Conditions

ST Elevation Myocardial Infarction; Coronary Stenting; Primary Angioplasty

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Same sitting PCI with complete revascularization

Intervention Type: PROCEDURE

revascualrization of the non IRA (infarct related artery) of \> 2.0 mm by coronary angioplasty/stenting at the time of primary PCI

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.

Group Type: ACTIVE_COMPARATOR

Staged PCI with complete revsacularization >48 hours pf primary PCI

Intervention Type: PROCEDURE

revascualrization of the non IRA (infarct related artery) of \> 2.0 mm by coronary angioplasty/stenting \>48 hours to 45 days post primary PCI

Interventions

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

Intervention Type: 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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Unity Health Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Akshay Bagai, MD

Role: PRINCIPAL_INVESTIGATOR

Unity Health Toronto

Asim Cheema, MD

Role: PRINCIPAL_INVESTIGATOR

Unity Health Toronto

Central Contacts

Val Panzov

Role: CONTACT

panzovv@smh.ca

416-864-6060 ext. 7125

Other Identifiers

17-254

Identifier Type: -

Identifier Source: org_study_id