Coronary Artery Disease Screening in Patients With Chronic Kidney Disease
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Grenoble
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Patients from the University Hospital of Grenoble
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
To assess the prognostic value of impaired coronary flow reserve measured by CZT myocardial perfusion imaging
Composite endpoint including cardiac mortality, non-fatal myocardial infarction, non-fatal ischemic stroke, and hospitalization for heart failure.
Time frame
2-year follow-upSecondary outcomes
1
To assess the prognostic value of coronary flow reserve to each individual component of the primary endpoint
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.
Time frame
2 years2
To assess the prognostic value of coronary flow reserve for Major Adverse Kidney Events (MAKE)
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
Time frame
At 1-year and 2-year follow-up3
To assess the number of Acute Kidney Injury (AKI) events during follow-up
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)
Time frame
2 years4
To assess the number of coronary revascularizations by coronary artery bypass grafting or percutaneous coronary intervention
Performed by calculating the rate of revascularization by coronary artery bypass grafting or percutaneous coronary intervention
Time frame
2 yearsSponsors and contacts
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Source ClinicalTrials.gov
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