Acute Myocardial InfarctionASSIST-CMRNCT01818960
Revascularization Strategies for STEMI; The CMR Endpoint Study
A study testing IRA-PCI and SS-PCI in people with Acute Myocardial Infarction, run by Unity Health Toronto at 3 sites in Canada.
Trial summary
Revascularization strategies for ST elevation myocardial infarction (STEMI) study (ASSIST-CMR) will compare the effects of two revascularization strategies [same sitting multivessel primary PCI (SS-PCI) and culprit vessel only primary PCI (IRA-PCI)] on myocardial infarct size (MIS) as determined by cardiac magnetic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- IRA-PCI and SS-PCI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 3 sitesCanada
- Study dates
- Apr 2014to Jul 2018
- 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
- High risk ST elevation myocardial infarction evidenced by: ≥2 mm ST elevation in 2 anterior or lateral leads; or ≥2 mm ST elevation in 2 inferior coupled with ST depression in 2 contiguous anterior leads for a total ST deviation of ≥8 mm; or New left bundle branch block with at least 1 mm concordant ST elevation.
- Multivessel CAD as evidenced by ≥1 significant (≥70% by visual assessment or FFR<0.80 for 50-70% stenosis) stenosis in non-IRA.
- Successful IRA-PCI with <10% 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.
- Non-IRA stenosis is a chronic total occlusion or located in left main artery.
- Hemodynamic instability evidenced by BP<90 mmHg, Killip class ≥2, need for inotropes/vasopressors.
- Known renal insufficiency (estimated GFR < 50ml/min).
- Contraindication to CMR.
Trial locations and contacts
3 sites in 1 country.
Canada3 sites, 3 recruiting
- Not yet recruiting
London Health Sciences
London, Ontario, N6A 5A5
Shahar Lavi, MD, 519-663-3611, shahar.lavi@lhsc.on.ca
- Not yet recruiting
Regina Qu'Appelle Health Region
Regina, Saskatchewan, S4P 0W5
Sheila Kelly, MSc, 306-522-7275, sheila@skresearch.com
Payam Dehghani, MD
- Recruiting
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
Mohammed Hussein, 4168646060 ext. 4014, husseinmo@smh.ca
Asim Cheema, MD
About this study
Official title: Revascularization Strategies for ST Elevation Myocardial Infarction; The Cardiac Magnetic Resonance Endpoint Study
Revascularization strategies for ST elevation myocardial infarction (STEMI) study (ASSIST-CMR) will compare the effects of two revascularization strategies [same sitting multivessel primary PCI (SS-PCI) and culprit vessel only primary PCI (IRA-PCI)] on myocardial infarct size (MIS) as determined by cardiac magnetic resonance (CMR) imaging in patients presenting with STEMI and multivessel disease (MVD).
- Conditions
- Acute Myocardial Infarction
- Being tested
- IRA-PCI, SS-PCI
- Keywords
- Stent, Myocardial Infarction, Coronary Intervention
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IRA-PCIProcedure or surgery
IRA only PCI at the time of Primary PCI
SS-PCIProcedure or surgery
Same sitting multivessel PCI as an adjunct to primary PCI
| Study group | Role | What they receive |
|---|---|---|
| SS-PCI | Active comparator | Same sitting multivessel PCI as an adjunct to primary PCI Receives: Procedure: SS-PCI |
| IRA-PCI | Active comparator | IRA only PCI with planned staging for non-IRA lesions Receives: Procedure: IRA-PCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infarct size by CMR
Measured: 90 days
Secondary outcomes (1)
MACE rate
MACE rate at 12 months
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2013 (estimated)
- Study startApr 2014
- Primary completionDec 2017 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- 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
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01818960
- Sponsor's protocol ID
- AC-103
- Acronym
- ASSIST-CMR
- Status last verified
- Jul 2016
- First submitted
- 23 Mar 2013
- Last updated
- 29 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Revascularization Strategies for ST Elevation Myocardial Infarction; The Cardiac Magnetic Resonance Endpoint Study
- ClinicalTrials.gov ID
- NCT01818960
- Acronym / sponsor ID
- ASSIST-CMR / AC-103
- Conditions
- Acute Myocardial Infarction
- Keywords
- Stent, Myocardial Infarction, Coronary Intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 27 Mar 2013 (estimated)
- 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.
Revascularization strategies for ST elevation myocardial infarction (STEMI) study (ASSIST-CMR) will compare the effects of two revascularization strategies [same sitting multivessel primary PCI (SS-PCI) and culprit vessel only primary PCI (IRA-PCI)] on myocardial infarct size (MIS) as determined by cardiac magnetic resonance (CMR) imaging in patients presenting with STEMI and multivessel disease (MVD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SS-PCI | Active comparator | Procedure: SS-PCISame sitting multivessel PCI as an adjunct to primary PCI |
| IRA-PCI | Active comparator | Procedure: IRA-PCIIRA only PCI with planned staging for non-IRA lesions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- High risk ST elevation myocardial infarction evidenced by: ≥2 mm ST elevation in 2 anterior or lateral leads; or ≥2 mm ST elevation in 2 inferior coupled with ST depression in 2 contiguous anterior leads for a total ST deviation of ≥8 mm; or New left bundle branch block with at least 1 mm concordant ST elevation.
- Multivessel CAD as evidenced by ≥1 significant (≥70% by visual assessment or FFR<0.80 for 50-70% stenosis) stenosis in non-IRA.
- Successful IRA-PCI with <10% 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.
- Non-IRA stenosis is a chronic total occlusion or located in left main artery.
- Hemodynamic instability evidenced by BP<90 mmHg, Killip class ≥2, need for inotropes/vasopressors.
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 |
|---|---|---|
| IRA-PCIIRA only PCI at the time of Primary PCI | Procedure or surgery | IRA-PCI |
| SS-PCISame sitting multivessel PCI as an adjunct to primary PCI | Procedure or surgery | SS-PCI |
Primary outcome
Infarct size by CMR
Time frame: 90 days
1 secondary outcome
MACE rate
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2016.
- 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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IRA-PCI and SS-PCI in people with Acute Myocardial Infarction, run by Unity Health Toronto at 3 sites in Canada.
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 29 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infarct size by CMR (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 29 Jul 2016.