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

August 25, 2017 updated by: Unity Health Toronto
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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3520

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Val Panzov
  • Phone Number: 7125 416-864-6060
  • Email: panzovv@smh.ca

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Major adverse clinical events
Time Frame: 90 days
Composite of all-cause mortality, myocardial infarction, heart failure and unplanned revascularization
90 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
All cause mortality
Time Frame: 90 days
90 days
Major bleeding
Time Frame: 90 days
90 days
Stroke
Time Frame: 90 days
90 days
Contrast nephropathy
Time Frame: 90 days
90 days
Major vascular complication
Time Frame: 90 days
90 days
EQ-5D quality of life assessment
Time Frame: 90 days
90 days
Incremental Cost-Effectiveness Ratio (ICER)
Time Frame: 90 days
90 days
Myocardial infarction
Time Frame: 90 days
90 days
Heart failure
Time Frame: 90 days
90 days
Unplanned revascularization
Time Frame: 90 days
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Unity Health Toronto

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Akshay Bagai, MD, Unity Health Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2017

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2020

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 23, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 25, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 28, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 28, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 25, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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