NCT01552161

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

March 9, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 13, 2012

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

January 28, 2014

Status Verified

January 1, 2014

Enrollment Period

2 years

First QC Date

March 9, 2012

Last Update Submit

January 26, 2014

Conditions

Coronary Artery DiseaseAllergyAsthma

Keywords

AngiographyAtherosclerosisAsthmaTryptaseEosinophil cationic protein

Outcome Measures

Primary Outcomes (1)

  • Prevalence of allergic diseases

    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 Outcomes (3)

  • 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.

Study Arms (2)

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).

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients who underwent coronary angiography are eligible for the study.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinic of Internal Medicine, Asthma and Allergy

Lodz, 90-153, Poland

Location

Related Publications (12)

  • Szczeklik A, Dropinski J, Gora PF. Serum immunoglobulin E and sudden cardiac arrest during myocardial infarction. Coron Artery Dis. 1993 Nov;4(11):1029-32. doi: 10.1097/00019501-199311000-00012.

    PMID: 8173709BACKGROUND

  • Szczeklik A, Milner PC, Birch J, Watkins J, Martin JF. Prolonged bleeding time, reduced platelet aggregation, altered PAF-acether sensitivity and increased platelet mass are a trait of asthma and hay fever. Thromb Haemost. 1986 Dec 15;56(3):283-7.

    PMID: 3563961BACKGROUND

  • Szczeklik A, Jawien J. Possible role of IgE in acute-phase response. Allergy. 1997 Nov;52(11):1149-50. doi: 10.1111/j.1398-9995.1997.tb00196.x. No abstract available.

    PMID: 9404576BACKGROUND

  • Kauhanen P, Kovanen PT, Reunala T, Lassila R. Effects of skin mast cells on bleeding time and coagulation activation at the site of platelet plug formation. Thromb Haemost. 1998 Apr;79(4):843-7.

    PMID: 9569202BACKGROUND

  • Wang J, Cheng X, Xiang MX, Alanne-Kinnunen M, Wang JA, Chen H, He A, Sun X, Lin Y, Tang TT, Tu X, Sjoberg S, Sukhova GK, Liao YH, Conrad DH, Yu L, Kawakami T, Kovanen PT, Libby P, Shi GP. IgE stimulates human and mouse arterial cell apoptosis and cytokine expression and promotes atherogenesis in Apoe-/- mice. J Clin Invest. 2011 Sep;121(9):3564-77. doi: 10.1172/JCI46028. Epub 2011 Aug 8.

    PMID: 21821913BACKGROUND

  • Heikkila HM, Trosien J, Metso J, Jauhiainen M, Pentikainen MO, Kovanen PT, Lindstedt KA. Mast cells promote atherosclerosis by inducing both an atherogenic lipid profile and vascular inflammation. J Cell Biochem. 2010 Feb 15;109(3):615-23. doi: 10.1002/jcb.22443.

    PMID: 20024959BACKGROUND

  • Kovanen PT. Mast cells in atherogenesis: actions and reactions. Curr Atheroscler Rep. 2009 May;11(3):214-9. doi: 10.1007/s11883-009-0033-7.

    PMID: 19361353BACKGROUND

  • Lindstedt KA, Kovanen PT. Mast cells in vulnerable coronary plaques: potential mechanisms linking mast cell activation to plaque erosion and rupture. Curr Opin Lipidol. 2004 Oct;15(5):567-73. doi: 10.1097/00041433-200410000-00011.

    PMID: 15361793BACKGROUND

  • Kovanen PT. Mast cells: multipotent local effector cells in atherothrombosis. Immunol Rev. 2007 Jun;217:105-22. doi: 10.1111/j.1600-065X.2007.00515.x.

    PMID: 17498055BACKGROUND

  • Kwon JS, Kim YS, Cho AS, Cho HH, Kim JS, Hong MH, Jeong SY, Jeong MH, Cho JG, Park JC, Kang JC, Ahn Y. The novel role of mast cells in the microenvironment of acute myocardial infarction. J Mol Cell Cardiol. 2011 May;50(5):814-25. doi: 10.1016/j.yjmcc.2011.01.019. Epub 2011 Feb 3.

    PMID: 21295578BACKGROUND

  • Deliargyris EN, Upadhya B, Sane DC, Dehmer GJ, Pye J, Smith SC Jr, Boucher WS, Theoharides TC. Mast cell tryptase: a new biomarker in patients with stable coronary artery disease. Atherosclerosis. 2005 Feb;178(2):381-6. doi: 10.1016/j.atherosclerosis.2004.09.008.

    PMID: 15694948BACKGROUND

  • Kervinen H, Kaartinen M, Makynen H, Palosuo T, Manttari M, Kovanen PT. Serum tryptase levels in acute coronary syndromes. Int J Cardiol. 2005 Sep 30;104(2):138-43. doi: 10.1016/j.ijcard.2004.10.023.

    PMID: 16168805BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples for total IgE, specific IgE and markers of inflammation.

MeSH Terms

Conditions

Coronary Artery DiseaseHypersensitivityAsthmaAtherosclerosis

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesImmune System DiseasesBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, Immediate

Study Officials

  • Piotr Kuna, Prof.

    Medical University of Lodz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 9, 2012

First Posted

March 13, 2012

Study Start

April 1, 2010

Primary Completion

April 1, 2012

Study Completion

June 1, 2012

Last Updated

January 28, 2014

Record last verified: 2014-01

Locations

PL(1)