Genetics of CRP in Families With Myocardial Infarction

Cardiovascular Diseases Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00064519
• Other study ID #: 1225
• Secondary ID: R01HL074321
• Status: Completed
• Phase: N/A
• First received: July 8, 2003
• Last updated: September 22, 2015
• Start date: July 2003
• Est. completion date: June 2008

Study information

• Verified date: September 2015
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

To investigate the genetics of C reactive protein in families with myocardial infarction.

Description:

BACKGROUND:

Coronary artery disease (CAD) and myocardial infarction (MI) are the leading causes of death in the Western world. Numerous epidemiological studies have demonstrated the impact of various risk factors, such as arterial hypertension, hypercholesterolemia and diabetes mellitus. While these risk factors are partly under genetic control, a positive family history remains an additional independent predictor of CAD, suggesting the presence of as yet unidentified susceptibility loci. Given the enormous public health burden of CAD, there is significant interest in identifying its specific genetic foundations. As intensive experimental investigations continue, the inflammatory component of the disease process leading to atherosclerosis evolves as a key aspect in the disease process. Recent evidence demonstrates that systemic markers of inflammation such as C reactive protein (CRP) can predict those at high risk of coronary events. CRP emerges with much attention as both a diagnostic marker and therapeutic target with serum levels determined to a significant extent by genetic factors.

DESIGN NARRATIVE:

To elucidate the genetic basis of the inflammatory component of myocardial infarction and the regulation of C reactive protein, a gene function oriented evaluation of candidate genes will be conducted. Therefore the specific aims are as follows, 1. Identify positional candidate genes within regions identified for MI and CRP which are functionally related to inflammation and inflammatory processes. Sequence variation in selected candidate genes will be identified. 2. Evaluate the effect of these variants with regard to MI and CRP in two different ethnic populations: a family set of European Caucasians and a population-based, Hispanic family dataset. The role of CRP will be evaluated as a predictor of cardiovascular events in the study populations. Since clinical follow up data are available on both study populations, the extent to which CRP contributes to an increased risk for cardiovascular events will be analyzed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1406
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 100 Years

Eligibility

1. First Part DNA Collection

a.) Inclusion Criteria i.) Being 18 years of age or older. ii.) Having had a cardiac catheterization procedure performed or undergoing one in the near future.

iii.) A person having a family history of coronary artery disease and having at least one family member that has had a cardiac catheterization that is willing to participate.

iv.) Having coronary artery (right, left main, circumflex, marginal and/or diagonal) blockage in a specific portion of the vessel (ostial, proximal, mid and/or distal).

b.) Exclusion Criteria i.) Having had a bone marrow transplant.

2. Second Part Coronary Collateralization and Extended Phenotyping a.) Inclusion Criteria i.) Having participated in DNA collection. ii.) Having at least one coronary artery with 100% blockage or iii.) Having normal coronary arteries with no blockage b.) Exclusion Criteria i.) Having received a diagnosis and treatment for kidney disease, cancer, myocardial infarction within the last three (3) months.

ii.) Having a heart transplant.

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Coronary Artery Disease
• Coronary Disease
• Heart Diseases
• Infarction
• Myocardial Infarction

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Medical College of Wisconsin	National Heart, Lung, and Blood Institute (NHLBI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Association of markers with cardiovascular event		Event recorded at time of recruitment	No