Genetics of CRP in Families With Myocardial Infarction

September 22, 2015 updated by: Ulrich Broeckel MD, Medical College of Wisconsin
To investigate the genetics of C reactive protein in families with myocardial infarction.

Study Overview

Status

Completed

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Actual)

1406

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

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Individuals having CAD and individuals not having CAD

Description

  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 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
Families with MI

In conjunction with collaborators in Germany, we have established one of the largest collections of families with MI, comprising 1,406 individuals in 513 Western-European families. Based on this collection, our total genome scan and linkage analysis has identified a region on chromosome 14 with a significant linkage signal for myocardial infarction (LOD = 3.9, pointwise P = 0.00015, genome-wide P < 0.05)5. Preliminary results from an association study in a subset of these families has identified a small set of single nucleotide polymorphisms (SNPs) within candidate genes in this region as being suggestively associated with MI.

No drugs are to be administre

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Association of markers with cardiovascular event
Time Frame: Event recorded at time of recruitment
Event recorded at time of recruitment

Collaborators and Investigators

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

Sponsor

Medical College of Wisconsin

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Ulrich Broeckel, Medical College of Wisconsin

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

July 1, 2003

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

July 8, 2003

First Submitted That Met QC Criteria

July 9, 2003

First Posted (Estimate)

July 10, 2003

Study Record Updates

Last Update Posted (Estimate)

September 24, 2015

Last Update Submitted That Met QC Criteria

September 22, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1225
  • R01HL074321 (U.S. NIH Grant/Contract)

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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