An observational study in Coronary Artery Disease and Chronic Kidney Disease, sponsored by Instituto do Coracao. Completed at 1 site in Brazil. Per ClinicalTrials.gov, last updated 2026-07-13.
Sponsored by Instituto do Coracao · Observational
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.
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.
4,857 studies on the registry are indexed under Coronary Artery Disease; 890 are open to participants now.
This study's enrollment of 1,700 is above the median of 320 across 1,687 observational studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Instituto do Coracao is the lead sponsor of 17 studies on the registry; 2 are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients assigned to Coronary Artery Bypass Grafting (CABG)
Diagnostic Test: Creatinine
Patients assigned to Percutaneous Coronary Intervention (PCI)
Diagnostic Test: Creatinine
Patients assigned to Medical Therapy (MT)
Diagnostic Test: Creatinine
Renal Function Follow-Up for 5 years
Change in Renal Function over Time
The primary outcome in change in renal function over time, measured by change in eGFR
Time frame: Over a five-year follow-up period
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
Time frame: Over a five-year follow-up period
Progression to Advanced CKD
Progression to advanced CKD, defined as a eGFR \< 30mL/min/1,73m2
Time frame: Over a five-year follow-up period
Initiation of Renal Replacement Therapy
Initiation of renal replacement therapy, such as dialysis or kidney trnsplant
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
Hospitalization for heart failure or other cardiovascular events
Time frame: Over a five-year follow-up period
Plan to share: Undecided — The datasets analyzed during the present study are available from the corresponding author upon reasonable request.
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Ran from Oct 2025 to primary completion in Nov 2025, 1 month.
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This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Instituto do Coracao