Chronic Kidney Disease (CKD), Coronary Artery Disease (CAD)
Conditions
Keywords
Chronic Kidney Disease, Coronary Flow Reserve, coronary artery disease
Brief summary
Patients with chronic kidney disease (CKD) have a markedly increased cardiovascular risk, with coronary artery disease being a leading cause of morbidity and mortality. Conventional cardiovascular risk scores and non-invasive diagnostic tests have limited accuracy in this population, partly due to atypical symptoms and frequent structural heart disease. Coronary flow reserve (CFR) is a key marker of coronary microvascular dysfunction and has strong prognostic value, but its assessment is usually limited to invasive techniques. Recent advances in cadmium-zinc-telluride single-photon emission computed tomography (CZT-SPECT) allow non-invasive measurement of CFR. The EVACKD study aims to evaluate the prognostic value of CFR assessed by CZT-SPECT in patients with CKD for predicting major adverse cardiovascular events over a 2-year follow-up.
Interventions
None listed
Sponsors
University Hospital, Grenoble
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female patients aged over 18 years * Affiliated with the French social security system * Patients at renal risk based on albuminuria (Alb) and glomerular filtration rate (GFR \< 30 mL/min/1.73 m², or GFR \< 45 mL/min/1.73 m² with albuminuria \> 30 mg/g, or GFR \< 60 mL/min/1.73 m² with albuminuria \> 300 mg/g) * Patients undergoing, independently of the research and according to the clinician's decision as part of standard care, CZT-SPECT myocardial perfusion imaging with coronary flow reserve measurement for cardiovascular risk assessment * Having expressed no objection to participation in this study
Exclusion criteria
* Legally protected adult (Article L1121-8 of the French Public Health Code) * Person deprived of liberty (Article L1121-8 of the French Public Health Code) * Pregnant woman * Patient who has undergone a normal coronary exploration within the past year
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To assess the prognostic value of impaired coronary flow reserve measured by CZT myocardial perfusion imaging | 2-year follow-up | Composite endpoint including cardiac mortality, non-fatal myocardial infarction, non-fatal ischemic stroke, and hospitalization for heart failure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To assess the prognostic value of coronary flow reserve to each individual component of the primary endpoint | 2 years | To evaluate each component separately : Cardiac mortality rate, non-fatal myocardial infarction rate, non-fatal ischemic stroke rate, hospitalization rate for heart failure, and all-cause mortality rate. |
| To assess the prognostic value of coronary flow reserve for Major Adverse Kidney Events (MAKE) | At 1-year and 2-year follow-up | Rate of patients with Major Adverse Kidney Events (MAKE), defined by the composite endpoint of death, dependence on renal replacement therapy, and a ≥50% decline in estimated glomerular filtration rate (eGFR) from baseline |
| To assess the number of Acute Kidney Injury (AKI) events during follow-up | 2 years | Evaluation of the Acute Kidney Injury (AKI) rate classified into three grades: Grade 1 (1.5- to 2-fold increase in serum creatinine), Grade 2 (2- to 3-fold increase), and Grade 3 (\>3-fold increase or need for dialysis) |
| To assess the number of coronary revascularizations by coronary artery bypass grafting or percutaneous coronary intervention | 2 years | Performed by calculating the rate of revascularization by coronary artery bypass grafting or percutaneous coronary intervention |
| To assess the prevalence of ischemic heart disease without significant coronary artery stenosis (INOCA) | 2 years | Rate of ischemic heart disease without significant coronary artery stenosis (INOCA) |
Countries
France
Contacts
CONTACTGilles Barone Rochette
CONTACTClémence Charlon
Outcome results
None listed