Clinical trial NCT01822990: Circulating Anti-Beta2-glycoprotein Antibodies and Endothelial Dysfunction
Official title: Influence of Circulating Anti-beta2-glycoprotein I Antibodies on the Endothelial Function and NO Metabolism in Peripheral Arterial Disease Patients.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Arterial Disease
Keywords: Anti-beta2-glycoprotein antibodies
Peripheral arterial disease
Inflammation
Nitric oxide
Endothelial dysfunction
Lead sponsor: Hospital Universitario Getafe
Sponsor class: OTHER
First posted: 2013-04-04
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Circulating anti-beta2-glycoprotein I antibodies
timeFrame: 12 months
measure: Flow-mediated arterial dilatation (FMAD)
timeFrame: 12 months
measure: Nitrite serum levels
timeFrame: 12 months
measure: Highly sensitive C-reactive protein.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Getafe
country: Spain
facility: Hospital Universitario de Getafe
state: Madrid
Study officials:
affiliation: Hospital Universitario de Getafe
name: Cesar Varela, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario de Getafe
name: Joaquin De Haro, MD
role: STUDY_DIRECTOR
affiliation: Hospital Universitario de Getafe
name: Francisco Acin, MD, PhD
role: STUDY_DIRECTOR
References: