Hemostatic Endothelial Dysfunction in Patients With Peripheral Artery Disease

Endothelial Dysfunction Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04391374
• Other study ID #: 05/18
• Status: Completed
• Start date: January 2017
• Est. completion date: March 23, 2023

Study information

• Verified date: May 2023
• Source: Ryazan State Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 167
• Est. completion date: March 23, 2023
• Est. primary completion date: February 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Endothelial Dysfunction
• Graft Occlusion, Vascular
• Peripheral Arterial Disease
• Peripheral Artery Disease
• Restenosis of Peripheral Vascular Stent
• Restenosis, Vascular Graft

Intervention

Procedure:
• an arterial reconstructive procedure

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ryazan State Medical University

References & Publications (2)

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. — View 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/ — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	thrombosis	incidence of thrombotic complications in the target arterial segment	1 year
Primary	restenosis	incidence of restenosis in the target arterial segment	1 year
Primary	progression of atherosclerosis	detection of newly formed or progressing peripheral atherosclerotic lesions	1 year
Secondary	limb salvage rate	limb salvage rate in the target extremity	1 year
Secondary	acute myocardial infarction	incidence of acute myocardial infarction	1 year
Secondary	mortality rate	overall mortality rate	1 year