Genetic Predisposition of Coronary Artery Disease -- The COROGENE-Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2006 by Helsinki University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Helsinki University
ClinicalTrials.gov Identifier:
NCT00417534
First received: December 29, 2006
Last updated: July 2, 2007
Last verified: December 2006
  Purpose

The aim of this study is to identify genetic loci,or gene variations contributing to inflammation and to the development of CHD. We will compare coronary angiogram results to genetic findings within coronary artery disease patients and in patients with normal coronaries.


Condition
Coronary Disease
Inflammation

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Longitudinal
Official Title: Genetic Predisposition of Coronary Artery Disease in Patients Verified With Coronary Angiogram The COROGENE-Study

Resource links provided by NLM:


Further study details as provided by Helsinki University:

Estimated Enrollment: 5000
Study Start Date: June 2006
Estimated Study Completion Date: December 2009
Detailed Description:

Coronary artery disease (CAD) is a chronic inflammatory disease, progression of which may be accelerated by immunological mechanisms. Genes involved in regulation of inflammation and protection against infectious agents may affect picture of the disease . Major Histocompatibility Complex (MHC) region carries genes involved in innate and adaptive immunity and inflammation. We have for the first time, identified genetic factors located in HLA region, showing several fold risk for disease predisposition likely forming an important component to explain the high incidence of coronary heart disease in the Finnish population.

The aim of this study is to rerun our preliminary results, and further identify genetic loci, or gene variations contributing to the development of CHD. The strategy is to collect altogether 5000 patients assigned to coronary angiogram in Helsinki University Central Hospital. We will compare the angiogram results to genetic findings first in patients with normal coronaries, and in patients with different stages of CHD. Secondly we will compare phenotypic changes in inflammation and try to find out if the phenotype differs in different genotypes. Thirdly we will collect patients from hospital discharge registry, and compare mortality and morbidity results in different gene groups.

Finally, we aim to record echocardiograms of the aortic valves in altogether 3500 consecutive patients undergoing coronary angiography. We try to identify genetic loci and gene variations contributing to the fibrosis and calcification of the aortic valve.

The results of the study provide a possibility to develop a gene test to recognize patients at risk at its early stage, and needing for preventive medicine.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient assigned to coronary angiogram

Exclusion Criteria:

  • Inability to give informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00417534

Contacts
Contact: Juha P Sinisalo, MD, PhD +35894711 juha.sinisalo@hus.fi

Locations
Finland
Helsinki University Central Hospital, Division of Cardiology Recruiting
Helsinki, Finland, 00290
Contact: Juha P Sinisalo, MD, PhD    +35894711    juha.sinisalo@hus.fi   
Principal Investigator: Juha P Sinisalo, MD, PhD         
Sponsors and Collaborators
Helsinki University
Investigators
Principal Investigator: Juha P Sinisalo, MD, PhD Helsinki University Central Hospital, Division of Cardiology
  More Information

Additional Information:
Publications:

ClinicalTrials.gov Identifier: NCT00417534     History of Changes
Other Study ID Numbers: 214841
Study First Received: December 29, 2006
Last Updated: July 2, 2007
Health Authority: Finland: Ethics Committee

Keywords provided by Helsinki University:
Coronary Disease
Inflammation
Genetics
HLA Antigens
Aortic Valve

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Disease Susceptibility
Inflammation
Genetic Predisposition to Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on July 22, 2014