ST Elevation Myocardial InfarctionASSIST-MINCT03263468
Revascularization StrategIes for ST Elevation Myocardial Infarction Trial
A study testing Same sitting PCI with complete revascularization and Staged PCI with complete revsacularization >48 hours pf primary PCI in people with ST Elevation Myocardial Infarction and Coronary Stenting, run by Unity Health Toronto.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ST Elevation Myocardial Infarction, Coronary Stenting, Primary Angioplasty
- What is being tested?
- Same sitting PCI with complete revascularization and Staged PCI with complete revsacularization >48 hours pf primary PCI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,520 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2017to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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.
- Being tested
- Same sitting PCI with complete revascularization, Staged PCI with complete revsacularization >48 hours pf primary PCI
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Same sitting PCI with complete revascularizationProcedure or surgery
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 PCIProcedure or surgery
revascualrization of the non IRA (infarct related artery) of > 2.0 mm by coronary angioplasty/stenting >48 hours to 45 days post primary PCI
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Procedure: Staged PCI with complete revsacularization >48 hours pf primary PCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse clinical events
Composite of all-cause mortality, myocardial infarction, heart failure and unplanned revascularization
Measured: 90 days
Secondary outcomes (10)
Major bleeding
Measured: 90 days
Stroke
Measured: 90 days
Contrast nephropathy
Measured: 90 days
Major vascular complication
Measured: 90 days
EQ-5D quality of life assessment
Measured: 90 days
Incremental Cost-Effectiveness Ratio (ICER)
Measured: 90 days
Myocardial infarction
Measured: 90 days
Heart failure
Measured: 90 days
All cause mortality
Measured: 90 days
Unplanned revascularization
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2017
- Study start1 Sep 2017 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ST Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,520 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Akshay Bagai, MD, Principal investigator, Unity Health TorontoAsim Cheema, MD, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03263468
- Sponsor's protocol ID
- 17-254
- Acronym
- ASSIST-MI
- Status last verified
- Aug 2017
- First submitted
- 23 Aug 2017
- Last updated
- 28 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Revascularization StrategIes for ST Elevation Myocardial Infarction Trial
- ClinicalTrials.gov ID
- NCT03263468
- Acronym / sponsor ID
- ASSIST-MI / 17-254
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,520 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- 1 Sep 2017 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 28 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Same sitting complete revascularization | Experimental | Procedure: Same sitting PCI with complete revascularizationAfter 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). |
| Staged non-IRA PCI | Active comparator | Procedure: Staged PCI with complete revsacularization >48 hours pf primary PCIOnly 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Same sitting PCI with complete revascularizationrevascualrization of the non IRA (infarct related artery) of > 2.0 mm by coronary angioplasty/stenting at the time of primary PCI | Procedure or surgery | Same sitting complete revascularization |
| Staged PCI with complete revsacularization >48 hours pf primary PCIrevascualrization of the non IRA (infarct related artery) of > 2.0 mm by coronary angioplasty/stenting >48 hours to 45 days post primary PCI | Procedure or surgery | Staged non-IRA PCI |
Primary outcome
Major adverse clinical events
Time frame: 90 days
Composite of all-cause mortality, myocardial infarction, heart failure and unplanned revascularization
10 secondary outcomes
Major bleeding
Time frame: 90 days
Stroke
Time frame: 90 days
Contrast nephropathy
Time frame: 90 days
Major vascular complication
Time frame: 90 days
EQ-5D quality of life assessment
Time frame: 90 days
Incremental Cost-Effectiveness Ratio (ICER)
Time frame: 90 days
Myocardial infarction
Time frame: 90 days
Heart failure
Time frame: 90 days
All cause mortality
Time frame: 90 days
Unplanned revascularization
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Akshay Bagai, MD principal investigator
Unity Health Toronto
Asim Cheema, MD principal investigator
Unity Health Toronto
Questions about this trial
What is this clinical trial studying?
A study testing Same sitting PCI with complete revascularization and Staged PCI with complete revsacularization >48 hours pf primary PCI in people with ST Elevation Myocardial Infarction and Coronary Stenting, run by Unity Health Toronto.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Val Panzov (416-864-6060 ext. 7125, panzovv@smh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse clinical events (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2017.