Coronary Artery DiseasePhase 3ISCHEMIA-LVDNCT06566183
International Study of Comparative Health Effectiveness With Medical and Invasive Approaches-Left Ventricular Dysfunction Trial
A Phase 3 study testing Guideline-directed medical therapy (GDMT), Coronary artery bypass grafting (CABG) and Percutaneous coronary intervention (PCI). in people with Coronary Artery Disease and Cognitive Impairment, run by NYU Langone Health at 6 sites in 6 countries.
Trial summary
The ISCHEMIA-HF trial will randomize participants with multivessel coronary artery disease (CAD) with ejection fraction (EF) ≤40% in a 1:2:2 fashion to guideline-directed medical therapy (GDMT):coronary artery bypass grafting (CABG):percutaneous coronary intervention (PCI). Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Coronary Artery Disease, Cognitive Impairment, Heart Failure
- What is being tested?
- Guideline-directed medical therapy (GDMT), Coronary artery bypass grafting (CABG) and Percutaneous coronary intervention (PCI).
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 6 sitesin 6 countries
- Study dates
- Dec 2026to Dec 2032
- Phase
- Phase 3
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Left ventricular ejection fraction (LVEF) ≤ 40% within prior 6 months (any local measurement, made within the past 6 months using echocardiography, multigated acquisition (MUGA), computed tomography (CT) scanning, magnetic resonance imaging (MRI), or ventricular angiography is acceptable, provided no subsequent measurement above 40%)
- Participants with multivessel CAD (defined as severe 3 vessel disease or 2 vessel disease including left anterior descending (LAD) artery disease) on coronary CT angiography (CCTA) or invasive coronary angiography
- CAD amenable to either PCI or CABG as determined by the local heart team
- Participant is willing to comply with all aspects of the protocol, including adherence to the assigned strategy, medical therapy and follow-up visits
- Participant is able and willing to give written informed consent
Who cannot join
- Decompensated heart failure or cardiogenic shock in the past 48 hours prior to randomization
- Concomitant significant valvular heart disease requiring surgery
- Prior cardiac surgery
- Dementia with loss of capacity to consent (clinically evident or previously diagnosed)
- Stroke within the previous 6 months or spontaneous intracranial hemorrhage at any time
- History of noncompliance with medical therapy
- Life expectancy less than the duration of the trial due to non-cardiovascular comorbidity
- Pregnancy (known to be pregnant; to be confirmed before randomization, if applicable)
Trial locations and contacts
6 sites in 6 countries.
6 sites in 6 countries
About this study
Official title: ISCHEMIA-LVD: International Study of Comparative Health Effectiveness With Medical and Invasive Approaches-Left Ventricular Dysfunction Trial
The ISCHEMIA-HF trial will randomize participants with multivessel coronary artery disease (CAD) with ejection fraction (EF) ≤40% in a 1:2:2 fashion to guideline-directed medical therapy (GDMT):coronary artery bypass grafting (CABG):percutaneous coronary intervention (PCI).
- Conditions
- Coronary Artery Disease, Cognitive Impairment, Heart Failure
- Being tested
- Guideline-directed medical therapy (GDMT), Coronary artery bypass grafting (CABG), Percutaneous coronary intervention (PCI).
- Keywords
- Coronary Artery Disease, Heart Failure, Ejection Fraction
- Medical subject headings
- Coronary Artery Disease, Cognitive Dysfunction, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guideline-directed medical therapy (GDMT)Procedure or surgery
Participants receive guideline-directed medical therapy (GDMT).
Coronary artery bypass grafting (CABG)Procedure or surgery
Participants receive coronary artery bypass grafting (CABG).
Percutaneous coronary intervention (PCI).Procedure or surgery
Participants receive percutaneous coronary intervention (PCI).
| Study group | Role | What they receive |
|---|---|---|
| GDMT | Experimental | Participants with multivessel coronary artery disease (CAD) and heart failure with reduced ejection fraction (HFrEF) who are assigned to receive GDMT. Receives: Procedure: Guideline-directed medical therapy (GDMT) |
| CABG | Experimental | Participants with multivessel coronary artery disease (CAD) and heart failure with reduced ejection fraction (HFrEF) who are assigned to receive CABG. Receives: Procedure: Coronary artery bypass grafting (CABG) |
| PCI | Experimental | Participants with multivessel coronary artery disease (CAD) and heart failure with reduced ejection fraction (HFrEF) who are assigned to receive PCI. Receives: Procedure: Percutaneous coronary intervention (PCI). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Cognitive Score
A composite score of various cognitive measures. Note that the total score range, calculation and interpretation to be updated upon submission of study protocol/materials to NYU Grossman School of Medicine IRB.
Measured: Month 12
Kansas City Cardiomyopathy Questionnaire (KCCQ) Score
The KCCQ is an 8-item assessment of heart failure (HF)-related health status. The raw score is calculated using the response to each item; the total score transforms the raw score to a standardized score scaled from 0 to 100 and summarized in 25-point ranges, where scores represent health status as follows: 0 to 24: very poor to poor; 25 to 49: poor to fair; 50 to 74: fair to good; and 75 to 100: good to excellent.
Measured: Month 12
Composite Number of: Death, Nonfatal Myocardial infarction (MI), Stroke, and Hospitalization for HF
Composite calculation of the number participants who experience death, nonfatal MI, stroke, or hospitalization for HF in each arm.
Measured: Month 12
Secondary outcomes (5)
Composite Number of: Mild Cognitive Impairment (MCI), Probable Dementia or Persistent Disability
Composite calculation of the number of participants with MCI, probable dementia or persistent disability in each arm.
Measured: Month 12
Composite Number of: Death or Hospitalization for HF
Composite calculation of the number of participants who die or are hospitalized for HF in each arm.
Measured: Month 12
Composite Number of: Death or Hospitalization for Cardiovascular (CV) Cause
Composite calculation of the number of participants who die or are hospitalized due to CV-related causes in each arm.
Measured: Month 12
Seattle Angina Questionnaire (SAQ) Physical Limitations and Quality of Life Domain Score
The SAQ Physical Limitations and Quality of Life domain comprises 2 items of the SAQ corresponding with angina-related physical limitations and quality of life (QOL). The raw score is calculated using the response to each item; the total score transforms the raw score to a standardized score scaled from 0 to 100 and summarized in 25-point ranges where: 0 to 24 represents poor health status, 25 to 49 represents fair status, 50 to 74 represents good status, and 75 to 100 represents excellent status.
Measured: Month 12
Self-Care of Heart Failure Index (SCHFI)
The SCHFI is a 39-item questionnaire assessing HF patients' performance of self-care activities related to HF, including how often they complete self-care, how likely they are to perform certain activities, and how confident they feel in performing the activities. Each item is rated on a scale from 1-5; the total score is the sum of responses and ranges from 39-195. Higher scores indicate greater overall performance of self-care activities related to HF.
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2024
- Study startDec 2026 (estimated)
- Primary completionDec 2030 (estimated)
- Study completionDec 2032 (estimated)
Why it stopped: Study temporarily paused.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- S. Bangalore, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06566183
- Sponsor's protocol ID
- Pending
- Acronym
- ISCHEMIA-LVD
- Status last verified
- Jun 2026
- First submitted
- 20 Aug 2024
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Sripal.bangalore@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ISCHEMIA-LVD: International Study of Comparative Health Effectiveness With Medical and Invasive Approaches-Left Ventricular Dysfunction Trial
- ClinicalTrials.gov ID
- NCT06566183
- Acronym / sponsor ID
- ISCHEMIA-LVD / Pending
- Conditions
- Coronary Artery Disease, Cognitive Impairment, Heart Failure
- Keywords
- Coronary Artery Disease, Heart Failure, Ejection Fraction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Study temporarily paused.
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2032 (estimated)
- First posted
- 22 Aug 2024 (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.
The ISCHEMIA-HF trial will randomize participants with multivessel coronary artery disease (CAD) with ejection fraction (EF) ≤40% in a 1:2:2 fashion to guideline-directed medical therapy (GDMT):coronary artery bypass grafting (CABG):percutaneous coronary intervention (PCI).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GDMT | Experimental | Procedure: Guideline-directed medical therapy (GDMT)Participants with multivessel coronary artery disease (CAD) and heart failure with reduced ejection fraction (HFrEF) who are assigned to receive GDMT. |
| CABG | Experimental | Procedure: Coronary artery bypass grafting (CABG)Participants with multivessel coronary artery disease (CAD) and heart failure with reduced ejection fraction (HFrEF) who are assigned to receive CABG. |
| PCI | Experimental | Procedure: Percutaneous coronary intervention (PCI).Participants with multivessel coronary artery disease (CAD) and heart failure with reduced ejection fraction (HFrEF) who are assigned to receive PCI. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Left ventricular ejection fraction (LVEF) ≤ 40% within prior 6 months (any local measurement, made within the past 6 months using echocardiography, multigated acquisition (MUGA), computed tomography (CT) scanning, magnetic resonance imaging (MRI), or ventricular angiography is acceptable, provided no subsequent measurement above 40%)
- Participants with multivessel CAD (defined as severe 3 vessel disease or 2 vessel disease including left anterior descending (LAD) artery disease) on coronary CT angiography (CCTA) or invasive coronary angiography
- CAD amenable to either PCI or CABG as determined by the local heart team
- Participant is willing to comply with all aspects of the protocol, including adherence to the assigned strategy, medical therapy and follow-up visits
- Participant is able and willing to give written informed consent
Key exclusion criteria (8 listed)
- Decompensated heart failure or cardiogenic shock in the past 48 hours prior to randomization
- Concomitant significant valvular heart disease requiring surgery
- Prior cardiac surgery
- Dementia with loss of capacity to consent (clinically evident or previously diagnosed)
- Stroke within the previous 6 months or spontaneous intracranial hemorrhage at any time
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 |
|---|---|---|
| Guideline-directed medical therapy (GDMT)Participants receive guideline-directed medical therapy (GDMT). | Procedure or surgery | GDMT |
| Coronary artery bypass grafting (CABG)Participants receive coronary artery bypass grafting (CABG). | Procedure or surgery | CABG |
| Percutaneous coronary intervention (PCI).Participants receive percutaneous coronary intervention (PCI). | Procedure or surgery | PCI |
Primary outcome
Composite Cognitive Score
Time frame: Month 12
A composite score of various cognitive measures. Note that the total score range, calculation and interpretation to be updated upon submission of study protocol/materials to NYU Grossman School of Medicine IRB.
Kansas City Cardiomyopathy Questionnaire (KCCQ) Score
Time frame: Month 12
The KCCQ is an 8-item assessment of heart failure (HF)-related health status. The raw score is calculated using the response to each item; the total score transforms the raw score to a standardized score scaled from 0 to 100 and summarized in 25-point ranges, where scores represent health status as follows: 0 to 24: very poor to poor; 25 to 49: poor to fair; 50 to 74: fair to good; and 75 to 100: good to excellent.
Composite Number of: Death, Nonfatal Myocardial infarction (MI), Stroke, and Hospitalization for HF
Time frame: Month 12
Composite calculation of the number participants who experience death, nonfatal MI, stroke, or hospitalization for HF in each arm.
5 secondary outcomes
Composite Number of: Mild Cognitive Impairment (MCI), Probable Dementia or Persistent Disability
Time frame: Month 12
Composite Number of: Death or Hospitalization for HF
Time frame: Month 12
Composite Number of: Death or Hospitalization for Cardiovascular (CV) Cause
Time frame: Month 12
Seattle Angina Questionnaire (SAQ) Physical Limitations and Quality of Life Domain Score
Time frame: Month 12
Self-Care of Heart Failure Index (SCHFI)
Time frame: Month 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Individual participant dataSharing planned: Yes. The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Sripal.bangalore@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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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.
S. Bangalore, MD principal investigator
NYU Langone Health
6 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Guideline-directed medical therapy (GDMT), Coronary artery bypass grafting (CABG) and Percutaneous coronary intervention (PCI). in people with Coronary Artery Disease and Cognitive Impairment, run by NYU Langone Health at 6 sites in 6 countries.
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 5 inclusion and 8 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: paused, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Brazil, India, Mexico, Poland and 1 more country. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite Cognitive Score (time frame: Month 12). The study lists 3 primary outcomes in all. 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 5 Jun 2026.