Circulating Anti-Beta2-glycoprotein Antibodies and Endothelial Dysfunction

NCT01822990 | Completed

• 1 other identifier: ABGPINO150613
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Arterial Disease

Keywords

Anti-beta2-glycoprotein antibodies; Peripheral arterial disease; Inflammation; Nitric oxide; Endothelial dysfunction

Outcome Measures

Primary Outcomes (4)

• 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.

  12 months

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• Male gender
• Peripheral arterial disease diagnosis
• Intermittent claudication.
• Hemodynamic confirmation of the disease through non-invasive vascular studies.

You may not qualify if:

• Autoimmune disease
• Previous revascularization of the ischemic limb.
• Ischemic ulcers
• Previous history of organ transplants.
• Treatment with immunosuppressors

Sponsors & Collaborators

• Hospital Universitario Getafe: lead

Study Sites (1)

Hospital Universitario de Getafe

Getafe, Madrid, 28905, Spain

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum samples of all the subjects included.

MeSH Terms

Conditions

Peripheral Arterial Disease; Inflammation

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Cesar Varela, MD

  Hospital Universitario de Getafe

  PRINCIPAL INVESTIGATOR

• Joaquin De Haro, MD

  Hospital Universitario de Getafe

  STUDY DIRECTOR

• Francisco Acin, MD, PhD

  Hospital Universitario de Getafe

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study director

Study Record Dates

• First Submitted: March 26, 2013
• First Posted: April 4, 2013
• Study Start: February 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: April 4, 2013

Record last verified: 2013-03

Locations

ES (1)