Circulating Anti-Beta2-glycoprotein Antibodies and Endothelial Dysfunction

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Joaquin de Haro, M.D., Hospital Universitario Getafe
ClinicalTrials.gov Identifier:
NCT01822990
First received: March 26, 2013
Last updated: March 28, 2013
Last verified: March 2013

March 26, 2013
March 28, 2013
February 2011
July 2012   (final data collection date for primary outcome measure)
  • Circulating anti-beta2-glycoprotein I antibodies [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Highly sensitive C-reactive protein levels could be measured using a highly sensitive, automated immunoassay with the human serum samples.
Same as current
Complete list of historical versions of study NCT01822990 on ClinicalTrials.gov Archive Site
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Circulating Anti-Beta2-glycoprotein Antibodies and Endothelial Dysfunction
Influence of Circulating Anti-beta2-glycoprotein I Antibodies on the Endothelial Function and NO Metabolism in Peripheral Arterial Disease Patients.

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.

Not Provided
Observational [Patient Registry]
Observational Model: Case Control
Time Perspective: Prospective
12 Months
Retention:   Samples Without DNA
Description:

Serum samples of all the subjects included.

Probability Sample

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.

Peripheral Arterial Disease
Not Provided
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
July 2012
July 2012   (final data collection date for primary outcome measure)

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
Male
18 Years to 90 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01822990
ABGPINO150613
No
Joaquin de Haro, M.D., Hospital Universitario Getafe
Hospital Universitario Getafe
Not Provided
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
Hospital Universitario Getafe
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP