Hemostatic Endothelial Dysfunction in Patients With Peripheral Artery Disease

NCT04391374 | Completed

• 1 other identifier: 05/18
• Study Type: observational
• Target: 167
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Peripheral Artery Disease; Restenosis of Peripheral Vascular Stent; Restenosis, Vascular Graft; Endothelial Dysfunction

Keywords

hemostasis, endothelial dysfunction, restenosis, thrombosis

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• limb salvage rate

  1 year

• acute myocardial infarction

  1 year

• mortality rate

  1 year

Study Arms (3)

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

Interventions

an arterial reconstructive procedure PROCEDURE

Peripheral artery balloon angioplasty and stenting; Peripheral artery bypass grafting

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ryazan State Medical University: lead

Related Publications (2)

• 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.

  PMID: 34349046 RESULT

• 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.

  PMID: 30113592 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

peripheral blood samples for the assessment of the concentration of NO metabolites, PAI-1, sEPCR, and activity of vWF, FVIII.

MeSH Terms

Conditions

Peripheral Arterial Disease; Graft Occlusion, Vascular; Thrombosis

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Embolism and Thrombosis

Study Officials

• Nina Mzhavanadze, MD, PhD

  RyazSMU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2020
• First Posted: May 18, 2020
• Study Start: January 1, 2017
• Primary Completion: February 23, 2023
• Study Completion: March 23, 2023
• Last Updated: May 3, 2023

Record last verified: 2023-05