Circulating Anti-Beta2-glycoprotein Antibodies and Endothelial Dysfunction

Hospital Universitario Getafe

Status: Completed

Conditions: Peripheral Arterial Disease

Study type: Observational

Funder types: Other

Identifiers

NCT01822990

ABGPINO150613

Details and patient eligibility

About

Circulating anti-beta2-glycoprotein antibodies have been associated with coronary artery disease and peripheral arterial disease. This auto-antibodies could activate endothelial cells leading to the expression of leukocyte adhesion molecules and increasing the release of pro-inflammatory cytokines.

On the other hand, endothelial dysfunction of atherosclerotic patients acts as a primary pathogenic event, as it occur before structural changes are evident on angiogram or ultrasound scan. Loss of endothelial normal function causes vasoconstriction, local coagulation alterations and an increase arterial wall proliferation. This situation s been attributed to a reduction in nitric oxide bioactivity, and to an increase oxygen-free radical formation in the context of the pro-inflammatory status found in atherosclerosis.

Hypothesis: Circulating Anti-beta2-glycoprotein I antibodies could be associated with endothelial dysfunction and nitric oxide metabolism disruption en patients with peripheral arterial disease.

Enrollment: 60 patients

Sex: Male

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male gender
• Peripheral arterial disease diagnosis
• Intermittent claudication.
• Hemodynamic confirmation of the disease through non-invasive vascular studies.

Exclusion criteria

• Autoimmune disease
• Previous revascularization of the ischemic limb.
• Ischemic ulcers
• Previous history of organ transplants.
• Treatment with immunosuppressors

Trial design

60 participants in 2 patient groups

Atherosclerotic patients

Description:

Male patients with intermittent claudication.

Control subjects

Description:

healthy male subjects with normal results on vascular examination and no cardiovascular risk factors, who are not in receipt of any pharmacological treatment, matched by age within two years with peripheral arterial disease patients