Clinical trial NCT04391374: Hemostatic Endothelial Dysfunction in Patients With Peripheral Artery Disease
Official title: The Role of Hemostatic Markers of Endothelial Dysfunction in the Development of Disease Progression, Thrombotic Complications and Restenosis in Patients With Atherosclerotic Peripheral Artery Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Artery Disease
Restenosis of Peripheral Vascular Stent
Restenosis, Vascular Graft
Endothelial Dysfunction
Keywords: hemostasis, endothelial dysfunction, restenosis, thrombosis
Lead sponsor: Ryazan State Medical University
Sponsor class: OTHER
First posted: 2020-05-18
Enrollment: 167
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A prospective study is aimed at enrolling 200 patients with atherosclerotic peripheral arterial disease, Rutherford category 3-5. The patients with PAD are scheduled to undergo either open or endovascular reconstructive procedures on aorto-iliac and femoro-popliteal segment or conservative treatment alone. The subjects of similar age, sex, and ethnicity are to be divided into three groups, respectively.

Brief summary: The study is aimed at evaluating the role of the activity of the key hemostatic parameters of endothelial dysfunction (nitric oxide II (NO) metabolites, plasmin activator inhibitor-1 (PAI-1), von Willebrand factor (vWF), coagulation factor VIII (FVIII), soluble endothelial protein C receptors (sEPCR)) in the development of disease progression, thrombotic complications and restenosis in subjects with atherosclerotic peripheral artery disease.

Detailed description: The study will involve patients with atherosclerotic peripheral artery disease (Rutherford category 3-5). The subjects are to be divided into three groups:

Group A: patients who undergo bypass surgery with a synthetic graft on aorto-iliac or femoro-popliteal segment; Group B: patients who undergo endovascular balloon angioplasty and stenting on aorto-iliac or femoro-popliteal segment; Group C: patients who undergo standard of care conservative treatment.

Decisions on revascularization or conservative treatment alone is to be made by a team of vascular specialists in accordance with the severity of the disease, previous treatment, anatomy, possible need for repeat procedures in the future, and patient's preferences.

Eligibility criteria: Inclusion Criteria:

1. Males or females older than 40 years of age;
2. Presence of peripheral arterial disease of atherosclerotic origin.

Exclusion Criteria:

1. Males or females younger than 40 years of age;
2. Chronic lower limb ischemia of other ethiology (Buerger's disease, aortoarteritis etc.);
3. Active cancer or remission period less than 5 years;
4. Decompensated diabetes mellitus;
5. Pregnancy or breast-feeding for females.

Primary outcomes:
measure: thrombosis
timeFrame: 1 year
measure: restenosis
timeFrame: 1 year
measure: progression of atherosclerosis
timeFrame: 1 year
Secondary outcomes:
measure: limb salvage rate
timeFrame: 1 year
measure: acute myocardial infarction
timeFrame: 1 year
measure: mortality rate
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: RyazSMU
name: Nina Mzhavanadze, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kalinin RE, Suchkov IA, Mzhavanadze ND, Zhurina ON, Klimentova EA, Povarov VO. Coagulation Factor Activity and Hemostatic Markers of Endothelial Dysfunction in Patients with Peripheral Arterial Disease. Vasc Specialist Int. 2021 Aug 5;37:26. doi: 10.5758/vsi.210010.
citation: Kalinin RE, Suchkov IA, Mzhavanadze ND, Demikhov VG, Zhurina ON, Klimentova EA. [Hemostatic changes in patients with peripheral artery disease before and after bypass surgery]. Khirurgiia (Mosk). 2018;(8):46-49. doi: 10.17116/hirurgia2018846. Russian.