Hemostatic Endothelial Dysfunction in Patients With Peripheral Artery Disease

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

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.

Study Overview

• Status: Completed
• Conditions: Endothelial Dysfunction; Peripheral Artery Disease; Restenosis of Peripheral Vascular Stent; Restenosis, Vascular Graft
• Intervention / Treatment: Procedure: an arterial reconstructive procedure

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.

• Study Type: Observational
• Enrollment (Actual): 167

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Conservative treatment; Subjects with atherosclerotic peripheral artery disease (PAD) who undergo standard of care conservative treatment according to the current PAD guidelines.
Peripheral artery bypass grafting; Subjects with atherosclerotic peripheral artery disease who undergo an open bypass grafting with synthetic prosthesis in aorto-iliac or femoro-popliteal position	Procedure: an arterial reconstructive procedure
Peripheral artery balloon angioplasty and stenting; Subjects with atherosclerotic peripheral artery disease who undergo endovascular balloon angioplasty and stenting with bare-metal stents in aorto-iliac or femoro-popliteal position	Procedure: an arterial reconstructive procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
thrombosis	incidence of thrombotic complications in the target arterial segment	1 year
restenosis	incidence of restenosis in the target arterial segment	1 year
progression of atherosclerosis	detection of newly formed or progressing peripheral atherosclerotic lesions	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
limb salvage rate	limb salvage rate in the target extremity	1 year
acute myocardial infarction	incidence of acute myocardial infarction	1 year
mortality rate	overall mortality rate	1 year

Collaborators and Investigators

• Sponsor: Ryazan State Medical University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): February 23, 2023
• Study Completion (Actual): March 23, 2023

Study Registration Dates

• First Submitted: May 13, 2020
• First Submitted That Met QC Criteria: May 13, 2020
• First Posted (Actual): May 18, 2020

Study Record Updates

• Last Update Posted (Actual): May 3, 2023
• Last Update Submitted That Met QC Criteria: May 1, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: hemostasis, endothelial dysfunction, restenosis, thrombosis
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Postoperative Complications; Atherosclerosis; Peripheral Vascular Diseases; Peripheral Arterial Disease; Graft Occlusion, Vascular
• Other Study ID Numbers: 05/18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Basic demographic data, including sex, age, and ethnicity are to be shared if allowed by the privacy policy.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No