Cardiovascular Risk in Peripheral Artery Disease Patients Undergoing Endovascular Revascularisation

NCT07599540 | Active Not Recruiting

• 1 other identifier: 0120-235/2025-2711-4
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Peripheral Arterial Disease; Myocardial Injury; Troponin; NT-proBNP; Echocardiography; Endovascular Procedures; Biomarkers; Cardiovascular Diseases; Myocardial Ischemia

Keywords

Peripheral arterial disease (PAD); Endovascular revascularization; Peri-operative myocardial injury (PMI); High-sensitivity cardiac troponin (hs-cTnT/I); NT-proBNP; Left ventricular global longitudinal strain (LVGLS); Myocardial work (MW); Major adverse cardiovascular events (MACE); Major adverse limb events (MALE); Cardiovascular risk stratification; Echocardiography

Outcome Measures

Primary Outcomes (3)

• Major adverse cardiovascular events (MACE)

  composite endpoint of myocardial infarction, stroke, unstable angina, or cardiovascular death

  30 days and 1 year after the procedure

• Major adverse limb events (MALE)

  composite endpoint of untreated loss of patency of the revascularized segment, repeat intervention on the revascularized segment, or above- or below-knee amputation of the revascularized limb

  30 days and 1 year after the procedure

• All-cause mortality

  death from any reason

  30 days and 1 year after the procedure

Study Arms (1)

peripheral arterial disease patients

peripheral arterial disease patients following endovascular revascularization procedure

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

The study population will consist of approximately 500 adult patients with Peripheral Arterial Disease who are admitted to the University Medical Centre Ljubljana for elective or urgent endovascular revascularization treatment of lower extremity peripheral arterial disease, including patients with intermittent claudication and chronic limb-threatening ischemia. Participants will be recruited consecutively during hospitalization and enrolled after providing written informed consent.

You may qualify if:

• 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.

You may not qualify if:

• Active malignant disease.
• End-stage renal disease requiring dialysis treatment.
• Previous enrollment in the study.

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Study Sites (1)

University Medical Centre Ljubljana

Ljubljana, 1000, Slovenia

Location

Biospecimen

Retention: SAMPLES WITH DNA

* 2 x 4 mL biochemistry tube for subsequent inflammatory and oxidative stress biomarkers analysis (4 mL biochemistry tube) * TEMPUS tube for subsequent analysis genetic biomarkers

MeSH Terms

Conditions

Peripheral Arterial Disease; Cardiovascular Diseases; Myocardial Ischemia

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Peripheral Vascular Diseases; Heart Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, MD, specialist of cardiology, vascular medicine and internal medicine

Study Record Dates

• First Submitted: May 13, 2026
• First Posted: May 20, 2026
• Study Start: February 12, 2025
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)