NCT Number: NCT04391374
Hemostatic Endothelial Dysfunction in Patients With 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.
Looking for future studies?
Notify MeKey information
Conditions
Age range
40 year–85 year
Sex eligibility
All sexes
Study type
Observational
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Males or females older than 40 years of age;
- Presence of peripheral arterial disease of atherosclerotic origin.
Exclusion criteria
- 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.
Treatment and study plan
Primary outcomes
-
thrombosis
Time frame: 1 year
incidence of thrombotic complications in the target arterial segment
-
restenosis
Time frame: 1 year
incidence of restenosis in the target arterial segment
-
progression of atherosclerosis
Time frame: 1 year
detection of newly formed or progressing peripheral atherosclerotic lesions
Secondary outcomes
-
limb salvage rate
Time frame: 1 year
limb salvage rate in the target extremity
-
acute myocardial infarction
Time frame: 1 year
incidence of acute myocardial infarction
-
mortality rate
Time frame: 1 year
overall mortality rate
Sponsors and collaborators
Lead sponsor
Ryazan State Medical University
Other
Registry information
Official study 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
Important dates
- Study start
- 2017
- Primary completion
- 2023
- Study completion
- 2023
- First posted
- May 18, 2020
- Registry last updated
- May 3, 2023
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Effect of Transcutaneous Vagal Stimulation (TVS) on Endothelial Function in PAD
NCT03445754
Arterial Occlusive Diseases, Arteriosclerosis
Oklahoma City, Oklahoma, United States
View Trial DetailsA Study to Collect Data on the Treatment Pattern of Xarelto + Acetylsalicylic Acid in the Routine Clinical Practice in Patients Who Are Suffering From a Condition That Narrows the Blood Vessels Supplying the Heart and / or a Condition That Most Commonly Narrows the Blood Vessel in the Legs
NCT04401761
Arterial Occlusive Diseases, Arteriosclerosis
Multiple Locations, Belgium
View Trial DetailsVascular Lab Resource (VLR) Biorepository
NCT05628948
Aneurysm, Aneurysmal Disease
Cleveland, Ohio, United States
View Trial DetailsUnacylated Ghrelin to Improve Functioning in PAD
NCT04377126
Arterial Occlusive Diseases, Arteriosclerosis
Chicago, Illinois, United States
View Trial Details