Effects of Surgical, Percutaneous or Medical Treatments for Coronary Artery Disease on Renal Function: Long-Term Outcome. Cardiorenal-trial.

NCT07195747 | Not Yet Recruiting

• 1 other identifier: 6048/25/059
• Study Type: observational
• Target: 1,700
• Locations: 1 country
• Sites: 1

Brief 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. 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.

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

Outcome Measures

Primary Outcomes (1)

• Change in Renal Function over Time

  The primary outcome in change in renal function over time, measured by change in eGFR

  Over a five-year follow-up period

Secondary Outcomes (6)

• Incidence of New-Onset Chronic Kidney Disease (CKD)

  Over a five-year follow-up period

• Progression to Advanced CKD

  Over a five-year follow-up period

• Initiation of Renal Replacement Therapy

  Over a five-year follow-up period

• All-case mortality

  Over a five-year follow-up period

• Cardiovascular mortality

  Over a five-year follow-up period

Study Arms (3)

CABG

Patients assigned to Coronary Artery Bypass Grafting (CABG)

Diagnostic Test: Creatinine

PCI

Patients assigned to Percutaneous Coronary Intervention (PCI)

Diagnostic Test: Creatinine

MT

Patients assigned to Medical Therapy (MT)

Diagnostic Test: Creatinine

Interventions

Creatinine DIAGNOSTIC_TEST

Renal Function Follow-Up for 5 years

CABG; MT; PCI

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto do Coracao: lead

Study Sites (1)

Instituto do Coração (InCor) do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HCFMUSP)

São Paulo, São Paulo, 05403-900, Brazil

Location

MeSH Terms

Conditions

Coronary Artery Disease; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ezio De Martino Neto, Medical Doctor (M.D.)

CONTACT

+55 11 2661-5032; ezio.martino@fm.usp.br

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor (M.D.)

Study Record Dates

• First Submitted: September 19, 2025
• First Posted: September 29, 2025
• Study Start: October 1, 2025
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2028
• Last Updated: September 29, 2025

Record last verified: 2025-09

Locations

BR (1)