Circulating Anti-Beta2-glycoprotein Antibodies and Endothelial Dysfunction
|ClinicalTrials.gov Identifier: NCT01822990|
Recruitment Status : Completed
First Posted : April 4, 2013
Last Update Posted : April 4, 2013
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|
|Peripheral Arterial Disease|
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||60 participants|
|Observational Model:||Case Control|
|Target Follow-Up Duration:||12 Months|
|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 :||February 2011|
|Primary Completion Date :||July 2012|
|Study Completion Date :||July 2012|
Male patients with intermittent claudication.
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
- Circulating anti-beta2-glycoprotein I antibodies [ Time Frame: 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.
- Flow-mediated arterial dilatation (FMAD) [ Time Frame: 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
- Nitrite serum levels [ Time Frame: 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.
- Highly sensitive C-reactive protein. [ Time Frame: 12 months ]Highly sensitive C-reactive protein levels could be measured using a highly sensitive, automated immunoassay with the human serum samples.
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01822990
|Hospital Universitario de Getafe|
|Getafe, Madrid, Spain, 28905|
|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|