Circulating Anti-Beta2-glycoprotein Antibodies and Endothelial Dysfunction

NCT ID: NCT01822990

Last Updated: 2013-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-02-28

Study Completion Date

2012-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Peripheral Arterial Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Atherosclerotic patients

Male patients with intermittent claudication.

No interventions assigned to this group

Control subjects

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hospital Universitario Getafe

OTHER

Sponsor Role lead

Responsible Party

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Joaquin de Haro, M.D.

Study director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cesar Varela, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario de Getafe

Joaquin De Haro, MD

Role: STUDY_DIRECTOR

Hospital Universitario de Getafe

Francisco Acin, MD, PhD

Role: STUDY_DIRECTOR

Hospital Universitario de Getafe

Locations

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Hospital Universitario de Getafe

Getafe, Madrid, Spain

Site Status

Countries

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Spain

Other Identifiers

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ABGPINO150613

Identifier Type: -

Identifier Source: org_study_id

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