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AtherosclerosisNCT00090441

Risk Burden of Lipoprotein Metabolic Gene Haplotypes

An observational study of Atherosclerosis and Cardiovascular Diseases, run by Intermountain Health Care, Inc..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To investigate the role in coronary heart disease (CHD) of intragenic variation in a network of six genes affecting lipoprotein transport and metabolism. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
How many people
4,303 participants
Where
No sites listed yet
Study dates
Aug 2004to Jul 2008
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Study subjects for the primary association study were selected from Intermountain Healthcare's ongoing Angiographic Registry and DNA Bank.

Men aged ≤60 years and women ≤70 years. Approximately 3,000 subjects (∼2,000 CAD cases and ∼1,000 angiographically normal controls, matched 2:1 for sex, age, and date of registry entry) were selected. A separate set of cases with highly familial premature CAD (first-degree relative with CHD onset <55 in men, <65 in women) from the University of Utah Cardiovascular Genetics Family Tree Registry and a separate set of controls (randomly invited from a public records database) were enrolled as a replication set.

About this study

To investigate the role in coronary heart disease (CHD) of intragenic variation in a network of six genes affecting lipoprotein transport and metabolism.

Read the detailed description

BACKGROUND:

In recent years, a number of candidate genetic variants (e.g., single nucleotide polymorphisms, SNPs) have been reported to be associated with coronary heart disease (CHD). However, these association studies have suffered from variability and failures of replication. This may result in part from selection of marker SNPs in linkage disequilibrium (LD) with true disease-related SNPs or with other effect-modulating genetic variants. Other issues include the play of chance in samples of limited size, population stratification artifacts, and small effect size for single SNPs. A recent discovery is that the genome is organized into largely invariant DNA fragments at the population level characterized by infrequent recombination events interspersed with "hotspots" of recombination and designated "haplotype blocks". These haplotype blocks can be determined by creating a dense map of SNPs across the gene of interest and analyzing population level LD. A few SNPs then can be chosen that designate ("tag") each haplotype block and used to comprehensively assess disease associations across the entire gene. Applying this approach to multiple genes in pathways critical to vascular health and assessing combinations of genes is likely to increase the power to discover genetic associations with CHD risk.

DESIGN NARRATIVE:

The study will establish high density SNP maps across exons, splice regions, and 5' and 3' regulatory regions of 6 genes that play key roles in lipoprotein transport and metabolism (ABCA1, CETP, LCAT, HL, LPL, SRB1); introns will be examined for 2 of the genes (CETP, LPL). By analyzing combinations of haplotype-tagging (ht) SNPs, "genetic burden" can be scored and correlated with CHD risk at 4 levels: 1) biomarker (lipid/lipoprotein levels), 2) anatomic (angiographic) CHD, 3) clinical outcome (death/MI), and 4) (exploratory) response to lipid-lowering. Testing will be performed in 3 large, distinct, but complementary Utah populations at primary or secondary risk of premature CHD. Testing will occur in 2 stages to establish reproducibility: an initial screening phase followed by a confirmation phase (for genetic markers and combinations showing promise) in a larger, independent sample. The study will employ novel methods that combine high-throughput SNP discovery and genotyping capability with genetic epidemiological methods to identify the haplotype blocks within and surrounding the genes of interest, identify htSNPs, and assess disease associations with individual and combinations of htSNPs ("genetic burden"). To this, the study brings large, well characterized databases, assembled and followed for up to 9 years, which will be further expanded under the current project.

Medical subject headings
Atherosclerosis, Cardiovascular Diseases, Coronary Disease, Heart Diseases

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To discover all common single nucleotide polymorphisms among a set of 6 key genes in the reverse cholesterol transport system and test them for associations with angiographic coronary artery disease.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Aug 2004 (estimated)
  2. Study startAug 2004
  3. Primary completionJul 2008
  4. Study completionJul 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Retrospective
Enrolment
4,303 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00090441
Sponsor's protocol ID
1265
Other IDs
5R01HL071878-04
Status last verified
Dec 2012
First submitted
26 Aug 2004
Last updated
4 Jan 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Atherosclerosis and Cardiovascular Diseases, run by Intermountain Health Care, Inc..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To discover all common single nucleotide polymorphisms among a set of 6 key genes in the reverse cholesterol transport system and test them for associations with angiographic coronary artery disease.. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2013; AzTrials last refreshed its copy on 7 Nov 2026.

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