Cardiovascular Risk in Peripheral Artery Disease Patients Undergoing Endovascular Revascularisation
Slovenia500 participantsStarted 2025-02-12
Plain-language 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients with Peripheral Arterial Disease admitted to the University Medical Centre Ljubljana for endovascular treatment of lower extremity peripheral arterial disease.
* Ability and willingness to provide written informed consent after explanation of the purpose and procedures of the study.
Exclusion Criteria:
* Active malignant disease.
* End-stage renal disease requiring dialysis treatment.
* Previous enrollment in the study.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is actively following patients but no longer enrolling — does that mean the results could be available soon, and should we wait to see what they find before deciding on my treatment approach?
2The study is measuring troponin and NT-proBNP levels alongside echocardiography in PAD patients having endovascular procedures — could my doctor order similar cardiac biomarker tests before or after my procedure to get a clearer picture of my personal heart risk?
3Since this trial is tracking major adverse cardiovascular events and major adverse limb events together, does my doctor think my heart health is a factor we should be actively monitoring alongside the treatment of my leg arteries?
4This is a non-interventional observational study rather than a treatment trial — does that mean it's about understanding risk rather than testing a new therapy, and are there any actual treatment trials my doctor thinks would be worth considering in parallel?
5Given that all-cause mortality is one of the outcomes being tracked, how does my doctor assess my overall cardiovascular risk going into an endovascular procedure, and what does that mean for how we should prepare or monitor me afterward?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.