Influence of Circulating Anti-beta2-glycoprotein I Antibodies on the Endothelial Function and NO Metabolism in Peripheral Arterial Disease Patients.
Sponsor study identifier
observational
60
1 country
1
Study Start
February 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2012
Actual (reported)Study Completion
July 2012
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2012
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2011
Date type not reportedThis date has not been verified as actual or estimated.
July 2012
Actual (reported)July 2012
Actual (reported)March 26, 2013
Actual (reported)April 4, 2013
Actual (reported)Circulating anti-beta2-glycoprotein I antibodies
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.
12 months
Flow-mediated arterial dilatation (FMAD)
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
12 months
Nitrite serum levels
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.
12 months
Highly sensitive C-reactive protein.
Highly sensitive C-reactive protein levels could be measured using a highly sensitive, automated immunoassay with the human serum samples.
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
Cases: Male patients with intermittent claudication due to peripheral arterial disease after haemodynamic confirmation of the disease by Doppler and treadmill exercise testing. No previous history of autoimmune disease. Controls: Healthy male subjects with normal results on vascular examination and no cardiovascular risk factors, who were not in receipt of any pharmacological treatment, matched by age within two years with PAD patients.
Hospital Universitario de Getafe
Getafe, Madrid, 28905, Spain
Serum samples of all the subjects included.
Cesar Varela, MD
Hospital Universitario de Getafe
Joaquin De Haro, MD
Hospital Universitario de Getafe
Francisco Acin, MD, PhD
Hospital Universitario de Getafe
60 participants (actual enrollment reported by the registry).
First Submitted
March 26, 2013
First Posted
April 4, 2013
Study Start
February 2011
Date type not reportedThis date has not been verified as actual or estimated.
12 months
Contact the study team to confirm eligibility.
Primary Completion
July 2012
Actual (reported)Study Completion
July 2012
Actual (reported)Last Updated
April 4, 2013
Record last verified: 2013-03
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