Coronary Artery DiseaseNCT07362108
Cardiovascular Events Related to Treated Coronary Arteries in Stable Multivessel CAD
An observational study of Coronary Artery Disease and Stable Coronary Artery Disease, run by Instituto do Coracao.
Trial summary
This retrospective cohort study evaluates cardiovascular events directly related to treated coronary arteries in patients with stable multivessel coronary artery disease. Outcomes in patients undergoing coronary artery bypass grafting or percutaneous coronary intervention will be compared with those receiving… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Stable Coronary Artery Disease, Multivessel Coronary Artery Disease
- What is being tested?
- Coronary Artery Bypass Grafting, Percutaneous Coronary Intervention and Optimized Medical Therapy
- Type of treatment
- Surgery or procedure
- How many people
- 1,695 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 1995to 31 Dec 2025
- Phase
- Observational
- 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
Study population: Adult patients with stable multivessel coronary artery disease and documented myocardial ischemia, selected from the MASS (Medicine, Angioplasty, or Surgery Study) database at a single tertiary academic center.
Who may be able to join
- Patients with stable multivessel coronary artery disease, defined as ≥70% stenosis in at least two major epicardial coronary arteries, with documented myocardial ischemia and clinical indication for surgical, percutaneous, or medical treatment.
Who cannot join
- Patients with limited life expectancy, severe left ventricular dysfunction (ejection fraction <35%), recent acute coronary syndrome, recent revascularization procedures, significant valvular disease, chronic kidney disease (creatinine ≥2.0 mg/dL), active malignancy, or inability to complete long-term follow-up.
About this study
Official title: Cardiovascular Events Related to the Coronary Artery Treated by Surgical or Percutaneous Revascularization in Patients With Stable Multivessel Coronary Artery Disease: A Long-Term Comparison With Medical Therapy - Target Trial
This retrospective cohort study evaluates cardiovascular events directly related to treated coronary arteries in patients with stable multivessel coronary artery disease. Outcomes in patients undergoing coronary artery bypass grafting or percutaneous coronary intervention will be compared with those receiving optimized medical therapy alone. This study aims to improve understanding of how different treatment strategies impact long-term vessel-related outcomes in patients with stable multivessel coronary artery disease.
Read the detailed description
Previous studies evaluating coronary revascularization strategies have relied on broad composite endpoints, which may include events unrelated to the treated vessel. This study focuses on vessel-related outcomes, specifically non-fatal myocardial infarction and cardiac death attributable to the treated coronary artery. Patients were selected from the MASS (Medicine, Angioplasty, or Surgery Study) database at a single tertiary center. By analyzing vessel-specific events, this study aims to provide a more accurate assessment of the long-term impact of different treatment strategies in stable multivessel coronary artery disease.
- Conditions
- Coronary Artery Disease, Stable Coronary Artery Disease, Multivessel Coronary Artery Disease, Myocardial Ischemia
- Being tested
- Coronary Artery Bypass Grafting, Percutaneous Coronary Intervention, Optimized Medical Therapy
- Keywords
- Coronary artery bypass grafting, Percutaneous coronary intervention, Medical therapy, Stable coronary artery disease, Multivessel disease, Vessel-related outcomes, Myocardial infarction, Cardiac death, MASS study
- Medical subject headings
- Coronary Artery Disease, Myocardial Ischemia, Myocardial Infarction, Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary Artery Bypass GraftingProcedure or surgery
Surgical myocardial revascularization using coronary artery bypass grafting.
Percutaneous Coronary InterventionProcedure or surgery
Percutaneous coronary intervention performed according to standard clinical practice.
Optimized Medical TherapyOther
Guideline-directed medical therapy for stable coronary artery disease.
| Study group | Role | What they receive |
|---|---|---|
| Coronary Artery Bypass Grafting (CABG) | Patients with stable multivessel coronary artery disease treated with surgical coronary artery bypass grafting. Receives: Procedure: Coronary Artery Bypass Grafting | |
| Percutaneous Coronary Intervention (PCI) | Patients with stable multivessel coronary artery disease treated with percutaneous coronary intervention. Receives: Procedure: Percutaneous Coronary Intervention | |
| Medical Therapy | Patients with stable multivessel coronary artery disease treated exclusively with optimized medical therapy. Receives: Other: Optimized Medical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-fatal myocardial infarction related to the treated coronary artery
Measured: Up to 5 years of follow-up
Cardiac death attributable to the treated coronary artery
Measured: Up to 5 years of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start1 Jan 1995
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,695 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto do Coracao
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Thiago Ovanessian Hueb, Instituto do Coracao
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07362108
- Sponsor's protocol ID
- SDC 6147 25 158
- Status last verified
- Jan 2026
- First submitted
- 15 Jan 2026
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared publicly because this study is based on a retrospective institutional database with data ownership governed by institutional policies and local data protection regulations. De-identified data may be made available upon reasonable request, subject to approval by the investigators and the institutional ethics committee.
Publications
Hueb T, Bocchi EA, Rezende PC, Scudeler TL, Lima EG, Soares PR, Venancio FA, Tairova MS, Outuki G, Martins IJ, De Martino Neto E, Serrano Junior CV, Ramires JAF, Kalil Filho R. Impact of revascularization strategies versus optimized medical treatment on coronary events related only to revascularized arteries: a target clinical trial emulation approach. J Cardiothorac Surg. 2026 Jul 16. doi: 10.1186/s13019-026-04544-5. Online ahead of print.
PubMed 42464287
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Events Related to the Coronary Artery Treated by Surgical or Percutaneous Revascularization in Patients With Stable Multivessel Coronary Artery Disease: A Long-Term Comparison With Medical Therapy - Target Trial
- ClinicalTrials.gov ID
- NCT07362108
- Acronym / sponsor ID
- SDC 6147 25 158
- Conditions
- Coronary Artery Disease, Stable Coronary Artery Disease, Multivessel Coronary Artery Disease, Myocardial Ischemia
- Keywords
- Coronary artery bypass grafting, Percutaneous coronary intervention, Medical therapy, Stable coronary artery disease, Multivessel disease, Vessel-related outcomes, Myocardial infarction, Cardiac death
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,695 participants (actual)
- Lead sponsor
- Instituto do CoracaoOther government
- Study start
- 1 Jan 1995 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 23 Jan 2026 (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 retrospective cohort study evaluates cardiovascular events directly related to treated coronary arteries in patients with stable multivessel coronary artery disease. Outcomes in patients undergoing coronary artery bypass grafting or percutaneous coronary intervention will be compared with those receiving optimized medical therapy alone. This study aims to improve understanding of how different treatment strategies impact long-term vessel-related outcomes in patients with stable multivessel coronary artery disease.
Detailed description
Previous studies evaluating coronary revascularization strategies have relied on broad composite endpoints, which may include events unrelated to the treated vessel. This study focuses on vessel-related outcomes, specifically non-fatal myocardial infarction and cardiac death attributable to the treated coronary artery. Patients were selected from the MASS (Medicine, Angioplasty, or Surgery Study) database at a single tertiary center. By analyzing vessel-specific events, this study aims to provide a more accurate assessment of the long-term impact of different treatment strategies in stable multivessel coronary artery disease.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Coronary Artery Bypass Grafting (CABG) | – | Procedure: Coronary Artery Bypass GraftingPatients with stable multivessel coronary artery disease treated with surgical coronary artery bypass grafting. |
| Percutaneous Coronary Intervention (PCI) | – | Procedure: Percutaneous Coronary InterventionPatients with stable multivessel coronary artery disease treated with percutaneous coronary intervention. |
| Medical Therapy | – | Other: Optimized Medical TherapyPatients with stable multivessel coronary artery disease treated exclusively with optimized medical therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with stable multivessel coronary artery disease and documented myocardial ischemia, selected from the MASS (Medicine, Angioplasty, or Surgery Study) database at a single tertiary academic center.
Key inclusion criteria (1 listed)
- Patients with stable multivessel coronary artery disease, defined as ≥70% stenosis in at least two major epicardial coronary arteries, with documented myocardial ischemia and clinical indication for surgical, percutaneous, or medical treatment.
Key exclusion criteria (1 listed)
- Patients with limited life expectancy, severe left ventricular dysfunction (ejection fraction <35%), recent acute coronary syndrome, recent revascularization procedures, significant valvular disease, chronic kidney disease (creatinine ≥2.0 mg/dL), active malignancy, or inability to complete long-term follow-up.
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 |
|---|---|---|
| Coronary Artery Bypass GraftingSurgical myocardial revascularization using coronary artery bypass grafting. | Procedure or surgery | Coronary Artery Bypass Grafting (CABG) |
| Percutaneous Coronary InterventionPercutaneous coronary intervention performed according to standard clinical practice. | Procedure or surgery | Percutaneous Coronary Intervention (PCI) |
| Optimized Medical TherapyGuideline-directed medical therapy for stable coronary artery disease. | Other | Medical Therapy |
Primary outcome
Non-fatal myocardial infarction related to the treated coronary artery
Time frame: Up to 5 years of follow-up
Cardiac death attributable to the treated coronary artery
Time frame: Up to 5 years of follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Derived from this study: PubMed 42464287Hueb T, Bocchi EA, Rezende PC, Scudeler TL, Lima EG, Soares PR, Venancio FA, Tairova MS, Outuki G, Martins IJ, De Martino Neto E, Serrano Junior CV, Ramires JAF, Kalil Filho R. Impact of revascularization strategies versus optimized medical treatment on coronary events related only to revascularized arteries: a target clinical trial emulation approach. J Cardiothorac Surg. 2026 Jul 16. doi: 10.1186/s13019-026-04544-5. Online ahead of print.
- Individual participant dataSharing planned: No. Individual participant data will not be shared publicly because this study is based on a retrospective institutional database with data ownership governed by institutional policies and local data protection regulations. De-identified data may be made available upon reasonable request, subject to approval by the investigators and the institutional ethics committee.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Stable Coronary Artery Disease, run by Instituto do Coracao.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 23 Jan 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Non-fatal myocardial infarction related to the treated coronary artery (time frame: Up to 5 years of follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07362108, which also lists 1 linked publication.
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 23 Jan 2026.