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Circulating Anti-Beta2-glycoprotein Antibodies and Endothelial Dysfunction

Sponsor
Hospital Universitario Getafe (Other)
Overall Status
Completed
CT.gov ID
NCT01822990
Collaborator
(none)
60
Enrollment
1
Location
17
Duration (Months)
3.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    60 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Influence of Circulating Anti-beta2-glycoprotein I Antibodies on the Endothelial Function and NO Metabolism in Peripheral Arterial Disease Patients.
    Study Start Date :
    Feb 1, 2011
    Actual Primary Completion Date :
    Jul 1, 2012
    Actual Study Completion Date :
    Jul 1, 2012

    Arms and Interventions

    Arm Intervention/Treatment
    Atherosclerotic patients

    Male patients with intermittent claudication.
    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

    Outcome Measures

    Primary Outcome Measures

    1. Circulating anti-beta2-glycoprotein I antibodies [12 months]

      The titer of circulating anti-endothelial cell antibodies directed against beta2-glycoprotein antigens (Circulating ABGPI) could be detected by indirect immunofluorescence using a diagnosis reagent kit and subjects serum.

    2. Flow-mediated arterial dilatation (FMAD) [12 months]

      FMAD is an ultrasound test based on the ability of endothelial cells to detect changes in shear stress and is one of the most effective and reliable indirect methods for estimating endothelial dysfunction. The ultrasound transducer is applied proximal to the antecubital fossa, and a longitudinal image of the brachial artery is obtained. The basal arterial diameter is determined. A blood pressure cuff is then placed distal to the measurement area and inflated to a pressure of 250 mmHg for five minutes. New measurements of the arterial diameter in the final diastolic phase should be obtained, 60 seconds after the cuff is deflated

    3. Nitrite serum levels [12 months]

      Nitrite serum levels reflects the nitric oxide metabolism. Serum nitrite concentration could be measured by colorimetric analysis using the Griess reaction. This is a chemical reaction which uses sulphanilamide and naphthylethylenediamine dihydrochloride under acid conditions (phosphoric acid).The system is capable of detecting nitric oxide in a variety of biological and experimental fluids, like human serum samples.

    4. Highly sensitive C-reactive protein. [12 months]

      Highly sensitive C-reactive protein levels could be measured using a highly sensitive, automated immunoassay with the human serum samples.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital Universitario de Getafe Getafe Madrid Spain 28905

    Sponsors and Collaborators

    • Hospital Universitario Getafe

    Investigators

    • Principal Investigator: Cesar Varela, MD, Hospital Universitario de Getafe
    • Study Director: Joaquin De Haro, MD, Hospital Universitario de Getafe
    • Study Director: Francisco Acin, MD, PhD, Hospital Universitario de Getafe

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Joaquin de Haro, M.D., Study director, Hospital Universitario Getafe
    ClinicalTrials.gov Identifier:
    NCT01822990
    Other Study ID Numbers:
    • ABGPINO150613
    First Posted:
    Apr 4, 2013
    Last Update Posted:
    Apr 4, 2013
    Last Verified:
    Mar 1, 2013
    Keywords provided by Joaquin de Haro, M.D., Study director, Hospital Universitario Getafe
    Anti-beta2-glycoprotein antibodies
    Peripheral arterial disease
    Inflammation
    Nitric oxide
    Endothelial dysfunction
    Additional relevant MeSH terms:
    Peripheral Arterial Disease
    Peripheral Vascular Diseases

    Study Results

    No Results Posted as of Apr 4, 2013