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临床试验/NCT01552161
NCT01552161已完成不适用

Prevalence of Allergic Diseases and Atopy in Patients With Angiographically Confirmed Coronary Artery Disease

Medical University of Lodz1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2010年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
300
试验地点
1
主要终点
Prevalence of allergic diseases

研究概览

简要总结

The purpose of this study is to estimate the prevalence of allergic diseases and atopy among patients with angiographically confirmed coronary artery disease as well as to assess levels of serum allergic inflammation markers in this population.

详细描述

Cardiovascular disease (CVD) is one of the leading causes of death, disability and medical resources use worldwide. Atherosclerosis remains the basic pathology found in CVD. Based on theoretical knowledge and animal experimental models it can be hypothesized that allergic inflammation affects atherosclerotic plaque formation/disruption. The exact nature of such interaction remains unknown.

The process most probably takes place at the molecular level and involves both: specific interleukin formation and mast cells recruitment. On the one hand some pro-allergic interleukins have been found to inhibit atherosclerotic plaque formation in experimental animal models. However, other hypothesis conclude that mediators released by mast cells might encourage hypoxemia of the heart muscle cells and thus promote their necrosis. Mast cells and eosinophils -typically associated with allergy - are both found in human heart muscle, cross sections of coronary arteries and atherosclerotic plaques.

Atopic patients who are prone to IgE-mediated mast cell activation seem to run a lower risk of sudden cardiac death after myocardial infarction. It may be associated with the fact that atopy produces a mild haemostatic imbalance similar to that typical of aspirin - moderately long bleeding time, depressed platelet aggregability and delayed generation of thrombin in clotting blood. Tryptase, one of the mediators released from mast cells widely used marker of anaphylaxis, has recently been shown to be increased in sera of patients with angiographically significant narrowings in coronary arteries. These results are in accordance with the previous finding of increased total IgE (antibody involved in type I allergic reaction) post myocardial infarction. Allergic myocardial infarction (also known as Kounis syndrome) - a condition in which heart muscle ischemia results from allergic insult sometimes even in the absence of permanent coronary artery lesions - is another hint supporting the hypothesis of possible interaction between allergy and cardiovascular diseases.

Despite relatively many reports studying the association at molecular, in vitro and clinical level, the research investigating the problem as a whole, connecting laboratory data with clinical picture, is scarce. Our research aims at providing epidemiological evidence on the prevalence of allergy and atopy as well as serum allergy markers profile in subjects with coronary artery disease.

Our study is dedicated to post-coronary angiography subjects willing to express informed consent for study participation.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
30 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • available result of coronary angiography
  • able to express written informed consent for study participation
  • able to perform forced expiratory manoeuvre for spirometry

排除标准

  • ongoing infection
  • exacerbation of chronic disorder (e.g. asthma, COPD, CVD, chronic kidney disease, neoplasm<10 years from complete remission)

结局指标

主要结局

Prevalence of allergic diseases

时间窗: Within a month from study recruitment completion.

Asthma, allergic rhinitis, allergic concjunctivitis, atopic dermatitis, contact eczema, drug, food and insect venom allergy will be assessed through a structured questionnaire based on ISAAC and ECRHS questions regarding allergy symptoms. Additionally: Asthma diagnosis is verified through basic spirometry, reversibility test, skin prick tests and/or serum specific IgE. Allergic rhinitis diagnosis is verified through skin prick tests and/or serum specific IgE.

次要结局

  • Serum tryptase(Within a month from study recruitment completion.)
  • Serum eosinophil cationic protein(Within a month from study recruitment completion.)
  • Prevalence of atopy.(Within a month from study recruitment completion.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Piotr Kuna, MD, PhD

Professor

Medical University of Lodz

研究点 (1)

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