Circulating Anti-Beta2-glycoprotein Antibodies and Endothelial Dysfunction
NCT ID: NCT01822990
Last Updated: 2013-04-04
Study Results
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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COMPLETED
60 participants
OBSERVATIONAL
2011-02-28
2012-07-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
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
* Peripheral arterial disease diagnosis
* Intermittent claudication.
* Hemodynamic confirmation of the disease through non-invasive vascular studies.
Exclusion Criteria
* Previous revascularization of the ischemic limb.
* Ischemic ulcers
* Previous history of organ transplants.
* Treatment with immunosuppressors
18 Years
90 Years
MALE
Yes
Sponsors
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Hospital Universitario Getafe
OTHER
Responsible Party
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Joaquin de Haro, M.D.
Study director
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
Countries
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Other Identifiers
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ABGPINO150613
Identifier Type: -
Identifier Source: org_study_id
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