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Compares treatment options for Acute Myocardial Infarction
Official title Physiology-guided vs Angiography-guided Non-culprit Lesion Complete Revascularization for Acute MI & Multivessel Disease
ClinicalTrials.gov ID: NCT05701358
What this study is testing
- What it's testing
- COMPLETE-2 is a prospective, multi-centre, randomized controlled trial comparing a strategy of physiology-guided complete revascularization to angiography-guided complete revascularization in patients with acute ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI) and multivessel coronary artery disease (CAD) who have undergone successful culprit lesion Percutaneous Coronary Intervention (PCI). COMPLETE-2 OCT is a large scale, prospective, multi-centre, observational, imaging study of patients with STEMI or NSTEMI and multivessel CAD in a subset of eligible COMPLETE-2 patients.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients presenting with STEMI or type 1 NSTEMI and within 72 hours of successful culprit-lesion PCI
- Residual coronary artery disease defined as at least 1 additional non-infarct-related coronary artery stenosis that meets all of the following...
- Amenable to successful treatment with PCI
- At least 50% diameter stenosis by visual estimation
- At least 2.5 mm in diameter
You likely can't join if
- Planned or prior coronary artery bypass graft (CABG) surgery
- Inability to clearly identify a culprit lesion for STEMI or NSTEMI based on angiographic appearance and/or ECG changes and/or regional wall motion...
- Prior PCI of a non-culprit lesion in a different vessel from the culprit lesion within 45 days of randomization
- Planned medical treatment of all qualifying non-culprit lesions (i.e., no PCI)
- Presence of severe non-culprit-lesion stenosis with reduced epicardial flow (TIMI flow ≤ 2) or \>90% visual diameter stenosis
- Presence of a chronic total occlusion (CTO) if it is the only qualifying non-culprit lesion (patients with a CTO plus additional qualifying...
See the full eligibility criteria
- Patients presenting with STEMI or type 1 NSTEMI and within 72 hours of successful culprit-lesion PCI
- Residual coronary artery disease defined as at least 1 additional non-infarct-related coronary artery stenosis that meets all of the following criteria:
- Amenable to successful treatment with PCI
- At least 50% diameter stenosis by visual estimation
- At least 2.5 mm in diameter
- Planned complete revascularization strategy for qualifying MI
- Planned or prior coronary artery bypass graft (CABG) surgery
- Inability to clearly identify a culprit lesion for STEMI or NSTEMI based on angiographic appearance and/or ECG changes and/or regional wall motion abnormalities
- Prior PCI of a non-culprit lesion in a different vessel from the culprit lesion within 45 days of randomization
- Planned medical treatment of all qualifying non-culprit lesions (i.e., no PCI)
- Presence of severe non-culprit-lesion stenosis with reduced epicardial flow (TIMI flow ≤ 2) or \>90% visual diameter stenosis
- Presence of a chronic total occlusion (CTO) if it is the only qualifying non-culprit lesion (patients with a CTO plus additional qualifying non-culprit lesions are eligible)
- The only qualifying non-culprit lesion is in the same vessel territory as the culprit lesion
- Baseline STEMI or NSTEMI was due to a suspected non-atherothrombotic mechanism such as type 2 MI (supply-demand mismatch), including spontaneous coronary artery dissection or coronary artery embolism
- Non-cardiovascular co-morbidity with expected life expectancy \<2 years
- Any other medical, geographic, or social factor making study participation impractical or precluding 5 year follow-up
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- San Francisco, California, United States
- Wichita, Kansas, United States
- Baltimore, Maryland, United States
- Ann Arbor, Michigan, United States
- Coon Rapids, Minnesota, United States
- Jersey City, New Jersey, United States
- Cooperstown, New York, United States
- New York, New York, United States
- The Bronx, New York, United States
- Cleveland, Ohio, United States
- Charlottesville, Virginia, United States
- Westmead, New South Wales, Australia
- Vienna, Austria
- Montreal, Quebec, Canada
- Brampton, Canada
- Edmonton, Canada
- Hamilton, Canada
- Kingston, Canada
- Kitchener, Canada
+ 80 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; San Francisco, California, United States; Wichita, Kansas, United States; Baltimore, Maryland, United States; Ann Arbor, Michigan, United States; Coon Rapids, Minnesota, United States and 94 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.