Heart study aims to find best treatment for minorities with clogged arteries
NCT ID NCT06399705
First seen Jun 26, 2026 · Last updated Sep 09, 2026 · Updated 3 times
Summary
This study compares two common heart procedures—bypass surgery (CABG) and stenting (PCI)—in 600 minority patients with coronary artery disease. The goal is to see which approach leads to better survival and quality of life. Participants will be followed over time to track outcomes.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) with stenting
- What this could lead to
- If it succeeds, this could help doctors and patients choose the best heart procedure for minority populations, improving survival and quality of life.
- What could go wrong
- This is a large trial but results may not apply to all groups. Both procedures carry risks like infection, bleeding, or heart complications.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
About 600 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Oct 2024
- Expected to finish
-
Jan 2039
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Patient must identify as Black race or Hispanic ethnicity 2. Patient is at least 18 years old. 3. Multivessel or left main CAD is present for which revascularization is intended and for which there is equipoise between CABG and PCI according to local Heart Team assessment. 4. Ability to provide written informed consent and comply with all follow-up procedures, including QOL questionnaires. Exclusion Criteria: 1. ST-segment elevation MI within 3 days 2. Cardiogenic shock 3. Prior PCI within 1 year or any prior CABG anytime 4. Planned hybrid revascularization (PCI after CABG or CABG after PCI) 5. Planned single vessel revascularization (other than isolated left main disease) 6. Need for any cardiac surgical or interventional procedure other than coronary revascularization at the present time or anticipated within 3 years, with the exception that surgical or interventional left atrial appendage ligation or occlusion and/or atrial fibrillation ablation may be performed at site discretion either during or subsequent to the index revascularization procedure 7. Pregnancy (women of child-bearing potential must have a negative pregnancy test within 1 week before randomization) or intent to become pregnant within 1 year after randomization 8. Unable to tolerate, obtain or comply with dual antiplatelet therapy for at least 3 months if presentation with stable CAD or 6 months if presentation with a troponin-positive acute coronary syndrome 9. Current participation in another investigational drug or device study that has not reached its primary endpoint 10. Life-expectancy less than 3 years due to concomitant non-cardiac conditions 11. Any condition(s) are present that are likely to interfere with the study protocol procedures including medication adherence and follow-up through 10 years (e.g. mental disability, substance abuse, anticipated international relocation, etc.)
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Coronary artery disease are added.
By submitting, you agree to our Terms of use
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
18 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Adventist Health Glendale
RECRUITINGGlendale, California, 91206, United States
-
Ascension Saint Thomas Hospital
RECRUITINGNashville, Tennessee, 37205, United States
-
Ascension St. Vincent Cardiovascular Research Institute
RECRUITINGCarmel, Indiana, 46290, United States
-
Baptist Health Lexington
RECRUITINGLexington, Kentucky, 40503, United States
-
Baptist Health Louisville
RECRUITINGLouisville, Kentucky, 40207, United States
-
Baylor Scott and White
RECRUITINGDallas, Texas, 75246, United States
-
Columbia University Irving Medical Center/NewYork-Presbyterian Hospital
RECRUITINGNew York, New York, 10032, United States
-
Duke University
RECRUITINGDurham, North Carolina, 27710, United States
-
Emory University
RECRUITINGAtlanta, Georgia, 30322, United States
-
Englewood Hospital
RECRUITINGEnglewood, New Jersey, 07631, United States
-
Icahn School of Medicine - Mount Sinai Hospital
RECRUITINGNew York, New York, 10029, United States
-
Icahn School of Medicine - Mount Sinai Morningside
RECRUITINGNew York, New York, 10025, United States
-
Massachusetts General Hospital
RECRUITINGBoston, Massachusetts, 02114, United States
-
Methodist Le Bonheur Healthcare
RECRUITINGMemphis, Tennessee, 38104, United States
-
NewYork-Presbyterian Hospital - Queens
RECRUITINGFlushing, New York, 11355, United States
-
Ohio State University
RECRUITINGColumbus, Ohio, 43210, United States
-
Weill Cornell Medicine/NewYork-Presbyterian Hospital
RECRUITINGNew York, New York, 10065, United States
-
Westchester Medical Center
RECRUITINGValhalla, New York, 10595, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can heart stent patients go home in 6 hours?
- Can AI read heart scans to predict the next heart attack?
- Can a new drug cool the hidden inflammation that fuels heart disease?
- New CT scanner aims to cut unnecessary heart procedures
- Heart bypass surgeons test which vein layout keeps grafts open
- A soft patch that watches your heart beat in real time