NCT03263468

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,520

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2017

Longer than P75 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 28, 2017

Completed
4 days until next milestone

Study Start

First participant enrolled

September 1, 2017

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

August 28, 2017

Status Verified

August 1, 2017

Enrollment Period

3.3 years

First QC Date

August 23, 2017

Last Update Submit

August 25, 2017

Conditions

ST Elevation Myocardial InfarctionCoronary StentingPrimary Angioplasty

Outcome Measures

Primary Outcomes (1)

  • Major adverse clinical events

    Composite of all-cause mortality, myocardial infarction, heart failure and unplanned revascularization

    90 days

Secondary Outcomes (10)

  • Major bleeding

    90 days

  • Stroke

    90 days

  • Contrast nephropathy

    90 days

  • Major vascular complication

    90 days

  • EQ-5D quality of life assessment

    90 days

  • +5 more secondary outcomes

Study Arms (2)

Same sitting complete revascularization

EXPERIMENTAL

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

Staged non-IRA PCI

ACTIVE COMPARATOR

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

Interventions

Same sitting PCI with complete revascularizationPROCEDURE

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

Same sitting complete revascularization
Staged PCI with complete revsacularization >48 hours pf primary PCIPROCEDURE

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

Staged non-IRA PCI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Akshay Bagai, MD

    Unity Health Toronto

    PRINCIPAL INVESTIGATOR

  • Asim Cheema, MD

    Unity Health Toronto

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Val Panzov

CONTACT

416-864-6060panzovv@smh.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2017

First Posted

August 28, 2017

Study Start

September 1, 2017

Primary Completion

December 31, 2020

Study Completion

December 31, 2021

Last Updated

August 28, 2017

Record last verified: 2017-08