Prevalence of Allergic Diseases and Atopy in Subjects With Coronary Artery Disease

January 26, 2014 updated by: Piotr Kuna, MD, PhD, Medical University of Lodz

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

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Coronarography has been chosen as a verification tool for several reasons:

  • it gives more accurate diagnosis of clinically relevant coronary narrowings than basic ECG, ECG exercise test or coronary angioCT
  • it enables the distinction between typical angina pectoris and Prinzmetal's angina
  • it has become a common procedure in Poland giving a relatively large and diverse cohort of patients undergoing the procedure whom we could address

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Lodz, Poland, 90-153
        • Clinic of Internal Medicine, Asthma and Allergy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients who underwent coronary angiography are eligible for the study.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients with negative coronarography.
Subjects who underwent coronary angiography and were classified as having no critical lesions in coronary arteries (a lesion of up to 50% of artery lumen is accepted as non-critical).
Patients with positive coronarography
Subjects who underwent coronary angiography and were classified as having critical lesions in coronary arteries (over 50% narrowing of artery lumen).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of allergic diseases
Time Frame: 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.
Within a month from study recruitment completion.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum tryptase
Time Frame: Within a month from study recruitment completion.
Systemic tryptase will be measured with ImmunoCAP fluorescence enzyme immunoassay in patients sera.
Within a month from study recruitment completion.
Serum eosinophil cationic protein
Time Frame: Within a month from study recruitment completion.
Systemic eosinophil cationic protein (ECP) will be measured with ImmunoCAP fluorescence enzyme immunoassay in patients sera.
Within a month from study recruitment completion.
Prevalence of atopy.
Time Frame: Within a month from study recruitment completion.
Atopy is defined as increased serum total/specific IgE and/or positive skin prick tests in the absence of relevant allergy clinical symptoms.
Within a month from study recruitment completion.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Lodz

Collaborators

European Union
Ministry of Science and Higher Education, Poland

Investigators

  • Principal Investigator: Piotr Kuna, Prof., Medical University of Lodz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (ACTUAL)

April 1, 2012

Study Completion (ACTUAL)

June 1, 2012

Study Registration Dates

First Submitted

March 9, 2012

First Submitted That Met QC Criteria

March 12, 2012

First Posted (ESTIMATE)

March 13, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

January 28, 2014

Last Update Submitted That Met QC Criteria

January 26, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN402374938

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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