Coronary Artery DiseaseNCT07195747
Effects of Surgical, Percutaneous or Medical Treatments for Coronary Artery Disease on Renal Function: Long-Term Outcome. Cardiorenal-trial.
An observational study of Coronary Artery Disease and Chronic Kidney Disease, run by Instituto do Coracao at 1 site in Brazil.
Trial summary
Background: Coronary artery disease (CAD) is treated with coronary artery bypass grafting (CABG), percutaneous coronary intervention (PCI), or optimized medical therapy (OMT). Their cardiovascular outcomes are well studied, but renal effects remain unclear. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Artery Disease, Chronic Kidney Disease
- What is being tested?
- Creatinine
- How many people
- 1,700 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Oct 2025to 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants were selected from the MASS registry, which includes individuals with angiographically confirmed CAD and regularly followed by a dedicated multidisciplinary team. Eligible patients had stable multivessel CAD and were considered suitable candidates for any of the three conventional treatment strategies: optimized medical therapy (MT), coronary artery bypass grafting (CABG), or percutaneous coronary intervention (PCI). Stable CAD was defined as ≥70% stenosis in at least two major epicardial coronary arteries, together with evidence of myocardial ischemia, either by functional stress testing or by the presence of stable angina classified as Canadian Cardiovascular Society (CCS) class I-III.
Who may be able to join
- Multivessel coronary artery disease (CAD) documented by angiography (2 or more epicardial arteries with stenosis of 70% or more);
- Preserved left ventricular systolic function;
- Have undergone treatment with medical therapy (MT), coronary artery bypass graft (CABG) or percutaneous coronary artery intervention (PCI), using drug-eluting stents (DES) or bare-metal stents (BMS);
- Availability of baseline serum creatinine values at the time of enrollment;
- Availability of serum creatinine measurements for a minimum of five years.
Who cannot join
- Presence of acute coronary syndrome at baseline;
- Limited life expectancy due to noncardiac comorbidities;
- Inability to maintain regular outpatient follow-up;
- Significant left main coronary artery disease (stenosis greater than 50%);
- Advanced chronic kidney disease (estimated glomerular filtration rate [eGFR] less than 30mL/min/1,73m2);
- End-stage renal disease requiring dialysis or history of kidney transplantation.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto do Coração (InCor) do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HCFMUSP)
São Paulo, São Paulo, 05403-900
About this study
Background: Coronary artery disease (CAD) is treated with coronary artery bypass grafting (CABG), percutaneous coronary intervention (PCI), or optimized medical therapy (OMT). Their cardiovascular outcomes are well studied, but renal effects remain unclear.
Objective: To evaluate long-term renal outcomes of different CAD treatment strategies.
Read more
Methods: In this retrospective cohort from the MASS registry, patients with stable multivessel CAD and preserved ventricular function underwent OMT, CABG, or PCI. Annual creatinine was measured for ≥5 years, and eGFR calculated using CKD-EPI. The primary endpoint was change in renal function over time. Secondary endpoints included new-onset CKD, progression to advanced CKD, dialysis, and mortality. Analyses will use mixed-effects models and Cox regression.
Results: Over 1,700 patients met inclusion criteria. Longitudinal follow-up enables robust comparison of renal trajectories across treatment groups.
Conclusions: This trial highlights renal function as a primary outcome in CAD management, aiming to inform integrated strategies for patients with concurrent cardiovascular and renal risk.
Read the detailed description
Background: Coronary artery disease (CAD) treatment strategies-coronary artery bypass grafting (CABG), percutaneous coronary intervention (PCI), or optimized medical therapy (OMT)-have well-established cardiovascular outcomes, but their long-term renal effects remain underexplored. Renal dysfunction is a key prognostic factor in CAD, yet patients with chronic kidney disease (CKD) are often underrepresented in major trials.
Objectives: To evaluate the long-term impact of surgical, percutaneous, and medical treatment strategies for stable multivessel CAD on renal function, with emphasis on estimated glomerular filtration rate (eGFR) changes and incidence of renal dysfunction.
Methods: This retrospective single-center cohort study analyzed data from the MASS registry, including patients with stable multivessel CAD, preserved left ventricular function, and baseline/annual serum creatinine measurements over ≥5 years. Eligible patients underwent OMT, CABG, or PCI (drug-eluting or bare-metal stents). Primary outcome was change in eGFR over time. Secondary outcomes included new-onset CKD (eGFR <60 mL/min/1.73 m²), progression to advanced CKD (<30 mL/min/1.73 m²), need for renal replacement therapy, and mortality. Linear mixed-effects models assessed eGFR changes; time-to-event analyses (Kaplan-Meier, Cox regression) evaluated secondary outcomes.
Results: The cohort comprised over 1,700 patients meeting inclusion criteria. Longitudinal follow-up allowed for robust assessment of renal trajectories across treatment groups. Analyses will determine whether treatment modality independently predicts renal decline, adjusting for age, sex, diabetes, hypertension, and baseline eGFR.
Conclusions: This study addresses a major evidence gap by positioning renal function as a primary outcome in CAD management. Findings may inform more integrated decision-making for patients with concurrent cardiovascular and renal risk, supporting individualized therapy selection beyond traditional cardiovascular endpoints.
- Conditions
- Coronary Artery Disease, Chronic Kidney Disease
- Being tested
- Creatinine
- Keywords
- Coronary Artery Disease, Chronic Kidney Disease, Renal Function, Coronary Artery Bypass Grafting (CABG), Percutaneous Coronary Intervention (PCI), Medical Therapy, Log-Term Outcomes
- Medical subject headings
- Coronary Artery Disease, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CreatinineDiagnostic test
Renal Function Follow-Up for 5 years
| Study group | Role | What they receive |
|---|---|---|
| CABG | Patients assigned to Coronary Artery Bypass Grafting (CABG) Receives: Diagnostic Test: Creatinine | |
| PCI | Patients assigned to Percutaneous Coronary Intervention (PCI) Receives: Diagnostic Test: Creatinine | |
| MT | Patients assigned to Medical Therapy (MT) Receives: Diagnostic Test: Creatinine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Renal Function over Time
The primary outcome in change in renal function over time, measured by change in eGFR
Measured: Over a five-year follow-up period
Secondary outcomes (6)
Incidence of New-Onset Chronic Kidney Disease (CKD)
Incidence of new-onset chronic kidney disease (CKD), defined as eGFR < 60mL/min/1,73m2 in patients with previously normal renal function
Measured: Over a five-year follow-up period
Progression to Advanced CKD
Progression to advanced CKD, defined as a eGFR < 30mL/min/1,73m2
Measured: Over a five-year follow-up period
Initiation of Renal Replacement Therapy
Initiation of renal replacement therapy, such as dialysis or kidney trnsplant
Measured: Over a five-year follow-up period
All-case mortality
Measured: Over a five-year follow-up period
Cardiovascular mortality
Measured: Over a five-year follow-up period
Cardiovascular hospitalization
Hospitalization for heart failure or other cardiovascular events
Measured: Over a five-year follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2025
- Study start1 Oct 2025
- Primary completion1 Nov 2025
- Study completion31 Dec 2025
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.
- 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
- 1,700 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto do Coracao
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ezio De Martino Neto, Instituto do Coracao
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07195747
- Sponsor's protocol ID
- 6048/25/059
- Status last verified
- Sep 2025
- First submitted
- 19 Sep 2025
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The datasets analyzed during the present study are available from the corresponding author upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Surgical, Percutaneous or Medical Treatments for Coronary Artery Disease on Renal Function: Long-Term Outcome. Cardiorenal-trial.
- ClinicalTrials.gov ID
- NCT07195747
- Acronym / sponsor ID
- 6048/25/059
- Conditions
- Coronary Artery Disease, Chronic Kidney Disease
- Keywords
- Coronary Artery Disease, Chronic Kidney Disease, Renal Function, Coronary Artery Bypass Grafting (CABG), Percutaneous Coronary Intervention (PCI), Medical Therapy, Log-Term Outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,700 participants (actual)
- Lead sponsor
- Instituto do CoracaoOther government
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 29 Sep 2025 (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.
Background: Coronary artery disease (CAD) is treated with coronary artery bypass grafting (CABG), percutaneous coronary intervention (PCI), or optimized medical therapy (OMT). Their cardiovascular outcomes are well studied, but renal effects remain unclear.
Objective: To evaluate long-term renal outcomes of different CAD treatment strategies.
Methods: In this retrospective cohort from the MASS registry, patients with stable multivessel CAD and preserved ventricular function underwent OMT, CABG, or PCI. Annual creatinine was measured for ≥5 years, and eGFR calculated using CKD-EPI. The primary endpoint was change in renal function over time. Secondary endpoints included new-onset CKD, progression to advanced CKD, dialysis, and mortality. Analyses will use mixed-effects models and Cox regression.
Results: Over 1,700 patients met inclusion criteria. Longitudinal follow-up enables robust comparison of renal trajectories across treatment groups.
Conclusions: This trial highlights renal function as a primary outcome in CAD management, aiming to inform integrated strategies for patients with concurrent cardiovascular and renal risk.
Detailed description
Background: Coronary artery disease (CAD) treatment strategies-coronary artery bypass grafting (CABG), percutaneous coronary intervention (PCI), or optimized medical therapy (OMT)-have well-established cardiovascular outcomes, but their long-term renal effects remain underexplored. Renal dysfunction is a key prognostic factor in CAD, yet patients with chronic kidney disease (CKD) are often underrepresented in major trials.
Objectives: To evaluate the long-term impact of surgical, percutaneous, and medical treatment strategies for stable multivessel CAD on renal function, with emphasis on estimated glomerular filtration rate (eGFR) changes and incidence of renal dysfunction.
Methods: This retrospective single-center cohort study analyzed data from the MASS registry, including patients with stable multivessel CAD, preserved left ventricular function, and baseline/annual serum creatinine measurements over ≥5 years. Eligible patients underwent OMT, CABG, or PCI (drug-eluting or bare-metal stents). Primary outcome was change in eGFR over time. Secondary outcomes included new-onset CKD (eGFR <60 mL/min/1.73 m²), progression to advanced CKD (<30 mL/min/1.73 m²), need for renal replacement therapy, and mortality. Linear mixed-effects models assessed eGFR changes; time-to-event analyses (Kaplan-Meier, Cox regression) evaluated secondary outcomes.
Results: The cohort comprised over 1,700 patients meeting inclusion criteria. Longitudinal follow-up allowed for robust assessment of renal trajectories across treatment groups. Analyses will determine whether treatment modality independently predicts renal decline, adjusting for age, sex, diabetes, hypertension, and baseline eGFR.
Conclusions: This study addresses a major evidence gap by positioning renal function as a primary outcome in CAD management. Findings may inform more integrated decision-making for patients with concurrent cardiovascular and renal risk, supporting individualized therapy selection beyond traditional cardiovascular endpoints.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CABG | – | Diagnostic Test: CreatininePatients assigned to Coronary Artery Bypass Grafting (CABG) |
| PCI | – | Diagnostic Test: CreatininePatients assigned to Percutaneous Coronary Intervention (PCI) |
| MT | – | Diagnostic Test: CreatininePatients assigned to Medical Therapy (MT) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants were selected from the MASS registry, which includes individuals with angiographically confirmed CAD and regularly followed by a dedicated multidisciplinary team. Eligible patients had stable multivessel CAD and were considered suitable candidates for any of the three conventional treatment strategies: optimized medical therapy (MT), coronary artery bypass grafting (CABG), or percutaneous coronary intervention (PCI). Stable CAD was defined as ≥70% stenosis in at least two major epicardial coronary arteries, together with evidence of myocardial ischemia, either by functional stress testing or by the presence of stable angina classified as Canadian Cardiovascular Society (CCS) class I-III.
Key inclusion criteria (5 listed)
- Multivessel coronary artery disease (CAD) documented by angiography (2 or more epicardial arteries with stenosis of 70% or more);
- Preserved left ventricular systolic function;
- Have undergone treatment with medical therapy (MT), coronary artery bypass graft (CABG) or percutaneous coronary artery intervention (PCI), using drug-eluting stents (DES) or bare-metal stents (BMS);
- Availability of baseline serum creatinine values at the time of enrollment;
- Availability of serum creatinine measurements for a minimum of five years.
Key exclusion criteria (6 listed)
- Presence of acute coronary syndrome at baseline;
- Limited life expectancy due to noncardiac comorbidities;
- Inability to maintain regular outpatient follow-up;
- Significant left main coronary artery disease (stenosis greater than 50%);
- Advanced chronic kidney disease (estimated glomerular filtration rate [eGFR] less than 30mL/min/1,73m2);
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 |
|---|---|---|
| CreatinineRenal Function Follow-Up for 5 years | Diagnostic test | CABG, MT, PCI |
Primary outcome
Change in Renal Function over Time
Time frame: Over a five-year follow-up period
The primary outcome in change in renal function over time, measured by change in eGFR
6 secondary outcomes
Incidence of New-Onset Chronic Kidney Disease (CKD)
Time frame: Over a five-year follow-up period
Progression to Advanced CKD
Time frame: Over a five-year follow-up period
Initiation of Renal Replacement Therapy
Time frame: Over a five-year follow-up period
All-case mortality
Time frame: Over a five-year follow-up period
Cardiovascular mortality
Time frame: Over a five-year follow-up period
Cardiovascular hospitalization
Time frame: Over a five-year follow-up period
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 13 Jul 2026.
- Individual participant dataSharing planned: Undecided. The datasets analyzed during the present study are available from the corresponding author upon reasonable request.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Chronic Kidney Disease, run by Instituto do Coracao at 1 site in Brazil.
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 6 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 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. 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?
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?
Change in Renal Function over Time (time frame: Over a five-year follow-up period). 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 13 Jul 2026.