Clinical Trial

Cardiovascular Risk in Peripheral Artery Disease Patients Undergoing Endovascular Revascularisation

Study acronym: RISK
Active, Not Recruiting
View on ClinicalTrials.gov →
Summary
This study will investigate heart-related complications in patients with peripheral arterial disease (PAD) undergoing endovascular revascularization procedures to improve blood flow in the legs. Previous studies have shown that some patients develop silent heart injury after these procedures, even without symptoms, and that this may be associated with worse long-term outcomes. Approximately 500 patients will be included in the study. Blood tests for cardiac biomarkers, including high-sensitivity troponin and NT-proBNP, will be performed before and after the procedure. Participants will also undergo ultrasound examination of the heart to assess heart function, including advanced measures that may detect early or subtle heart damage. In addition, heart rate variability will be measured using a short electrocardiogram recording. Patients will be followed for 30 days and 1 year after the procedure to assess the occurrence of major cardiovascular events, limb-related complications, and death. Additional blood samples will be collected and stored for future analysis of inflammation, oxidative stress, and genetic markers that may help explain the mechanisms associated with heart injury and prognosis in these patients.
Trial Details
NCT Number NCT07599540
Lead Sponsor University Medical Centre Ljubljana
Conditions Peripheral Arterial Disease, Myocardial Injury, Troponin, NT-proBNP, Echocardiography, Endovascular Procedures, Biomarkers, Cardiovascular Diseases +1 more
Enrollment 500 participants
Start Date 2025-02-12
Primary Completion 2027-03-30 (estimated)
Study Completion 2027-12-30 (estimated)
Updated on ClinicalTrials.gov 2026-05-20