Cardiovascular DiseaseNCT00339599
Genetic Predictors of Cardiovascular Disease
An observational study of Cardiovascular Disease, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
This study, conducted in collaboration with the Johns Hopkins University School of Medicine, will explore the genetic influences on susceptibility to atherosclerotic cardiovascular disease (ASCVD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Disease
- How many people
- 2,306 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2005to 3 Aug 2015
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a sibling or first degree family member with heart disease
- Ability to give informed consent to participate in the study
- Age 18 years or older
- Ability to speak English or Spanish
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Cancer Institute (NCI), 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Study of Chemokine Markers and Genes as Predictors of Cardiovascular Disease
This study, conducted in collaboration with the Johns Hopkins University School of Medicine, will explore the genetic influences on susceptibility to atherosclerotic cardiovascular disease (ASCVD). Atherosclerosis is a chronic narrowing of the arteries caused by an incremental buildup of fatty substances on the linings of walls of arteries. This study will examine the role of genes related to the inflammatory process on the incidence of ASCVD and on levels of chemokines (proteins involved in inflammation).
DNA samples, chemokines levels and relevant clinical data from patients enrolled in Johns Hopkins's sibling and family heart studies are analyzed for specific gene markers. The studies include: Nurse Model in Black Families at Risk for Heart Disease; Genotypic Determinants of Aspirin Response in High Risk Families; and Coronary Disease Detection by Thallium SPECT and Fast CT. All of the enrolled patients have consented to have their DNA used for testing of genetic factors that may predict cardiovascular disease and do not contain patient identifier information.
Read the detailed description
Background:
Atherosclerosis is a chronic inflammatory disease classically triggered by hypertension, diabetes, smoking and elevated cholesterol.
It is hypothesized that genetic predisposition plays a crucial role in an individual's susceptibility to these risk factors with Single Nucleotide Polymorphisms (SNPs) being identified as functional mediators of key inflammatory genes.
Objectives:
To determine the frequency of haplotypes of SNP combinations in the proximal promoter region of MCP-1, the MCP-3 gene, and eotaxin gene in patients with risk factors for CVD and their siblings.
To determine the MCP-1 levels in an affected population with Coronary artery disease and their siblings and certain haplotypes to determine a functional association between MCP-1 levels and haplotype frequency.
Eligibility:
Eligibility criteria for enrollment in sib and family studies included: 1) having a sib or 1st degree family member with heart disease, 2) ability to give inform consent to participate in the study, 3) age 18 years or older, 4) ability to speak English or Spanish. The entire set of 2,000 samples available to the LDG will be analyzed. No subject will be excluded.
Design:
DNAs derived from properly consented subjects enrolled in three protocols sponsored by the Johns Hopkins Heart Study will be sent to the LGD and used to test specific markers in the MCP-1, MCP-3, and eotaxin chemokine family located in the C-C chemokine cluster on chromosome17q11.2.
A minimum of 11 SNPs will be examined.
Sib-pair analysis will be utilized to identify associated markers. Linear regressions will be used to analyze associations between genetic variations and chemokine levels. Haplotype will be assigned to unrelated individuals using the maximum likelihood approach.
The DNA samples, chemokine levels, and relevant clinical data provided by John Hopkins University School of Medicine will be coded and linked.
Following this study, the DNAs will be maintained in our repository and curated through our central Laboratory database. Loss or destruction of these samples will be annotated to our database and cannot impact the study participants in any way. We understand that studies subsequent to the completion of this protocol will require additional OHSR/IRB approval prior to commencement.
- Conditions
- Cardiovascular Disease
- Keywords
- Atherosclerosis, Single Nucleotide Polymorphisms, Monocyte Chemotactic Protein-1, Inflammation, Eotaxin
- Medical subject headings
- Cardiovascular Diseases, Atherosclerosis, Inflammation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2006 (estimated)
- Study start20 Sep 2005
- Study completion3 Aug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 2,306 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Janelle Cortner, Ph.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00339599
- Sponsor's protocol ID
- 999905247
- Other IDs
- 05-C-N247
- Status last verified
- 3 Aug 2015
- First submitted
- 19 Jun 2006
- Last updated
- 8 Nov 2019
- Results posted
- No
Publications
Ross R. Atherosclerosis--an inflammatory disease. N Engl J Med. 1999 Jan 14;340(2):115-26. doi: 10.1056/NEJM199901143400207. No abstract available.
PubMed 9887164Francis SE, Camp NJ, Dewberry RM, Gunn J, Syrris P, Carter ND, Jeffery S, Kaski JC, Cumberland DC, Duff GW, Crossman DC. Interleukin-1 receptor antagonist gene polymorphism and coronary artery disease. Circulation. 1999 Feb 23;99(7):861-6. doi: 10.1161/01.cir.99.7.861.
PubMed 10027806Rovin BH, Lu L, Saxena R. A novel polymorphism in the MCP-1 gene regulatory region that influences MCP-1 expression. Biochem Biophys Res Commun. 1999 Jun 7;259(2):344-8. doi: 10.1006/bbrc.1999.0796.
PubMed 10362511
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Chemokine Markers and Genes as Predictors of Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT00339599
- Acronym / sponsor ID
- 999905247
- Conditions
- Cardiovascular Disease
- Keywords
- Atherosclerosis, Single Nucleotide Polymorphisms, Monocyte Chemotactic Protein-1, Inflammation, Eotaxin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,306 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 20 Sep 2005
- Study completion
- 3 Aug 2015
- First posted
- 21 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study, conducted in collaboration with the Johns Hopkins University School of Medicine, will explore the genetic influences on susceptibility to atherosclerotic cardiovascular disease (ASCVD). Atherosclerosis is a chronic narrowing of the arteries caused by an incremental buildup of fatty substances on the linings of walls of arteries. This study will examine the role of genes related to the inflammatory process on the incidence of ASCVD and on levels of chemokines (proteins involved in inflammation).
DNA samples, chemokines levels and relevant clinical data from patients enrolled in Johns Hopkins's sibling and family heart studies are analyzed for specific gene markers. The studies include: Nurse Model in Black Families at Risk for Heart Disease; Genotypic Determinants of Aspirin Response in High Risk Families; and Coronary Disease Detection by Thallium SPECT and Fast CT. All of the enrolled patients have consented to have their DNA used for testing of genetic factors that may predict cardiovascular disease and do not contain patient identifier information.
Detailed description
Background:
Atherosclerosis is a chronic inflammatory disease classically triggered by hypertension, diabetes, smoking and elevated cholesterol.
It is hypothesized that genetic predisposition plays a crucial role in an individual's susceptibility to these risk factors with Single Nucleotide Polymorphisms (SNPs) being identified as functional mediators of key inflammatory genes.
Objectives:
To determine the frequency of haplotypes of SNP combinations in the proximal promoter region of MCP-1, the MCP-3 gene, and eotaxin gene in patients with risk factors for CVD and their siblings.
To determine the MCP-1 levels in an affected population with Coronary artery disease and their siblings and certain haplotypes to determine a functional association between MCP-1 levels and haplotype frequency.
Eligibility:
Eligibility criteria for enrollment in sib and family studies included: 1) having a sib or 1st degree family member with heart disease, 2) ability to give inform consent to participate in the study, 3) age 18 years or older, 4) ability to speak English or Spanish. The entire set of 2,000 samples available to the LDG will be analyzed. No subject will be excluded.
Design:
DNAs derived from properly consented subjects enrolled in three protocols sponsored by the Johns Hopkins Heart Study will be sent to the LGD and used to test specific markers in the MCP-1, MCP-3, and eotaxin chemokine family located in the C-C chemokine cluster on chromosome17q11.2.
A minimum of 11 SNPs will be examined.
Sib-pair analysis will be utilized to identify associated markers. Linear regressions will be used to analyze associations between genetic variations and chemokine levels. Haplotype will be assigned to unrelated individuals using the maximum likelihood approach.
The DNA samples, chemokine levels, and relevant clinical data provided by John Hopkins University School of Medicine will be coded and linked.
Following this study, the DNAs will be maintained in our repository and curated through our central Laboratory database. Loss or destruction of these samples will be annotated to our database and cannot impact the study participants in any way. We understand that studies subsequent to the completion of this protocol will require additional OHSR/IRB approval prior to commencement.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Have a sibling or first degree family member with heart disease
- Ability to give informed consent to participate in the study
- Age 18 years or older
- Ability to speak English or Spanish
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2019.
- Background: PubMed 9887164Ross R. Atherosclerosis--an inflammatory disease. N Engl J Med. 1999 Jan 14;340(2):115-26. doi: 10.1056/NEJM199901143400207. No abstract available.
- Background: PubMed 10027806Francis SE, Camp NJ, Dewberry RM, Gunn J, Syrris P, Carter ND, Jeffery S, Kaski JC, Cumberland DC, Duff GW, Crossman DC. Interleukin-1 receptor antagonist gene polymorphism and coronary artery disease. Circulation. 1999 Feb 23;99(7):861-6. doi: 10.1161/01.cir.99.7.861.
- Background: PubMed 10362511Rovin BH, Lu L, Saxena R. A novel polymorphism in the MCP-1 gene regulatory region that influences MCP-1 expression. Biochem Biophys Res Commun. 1999 Jun 7;259(2):344-8. doi: 10.1006/bbrc.1999.0796.
Related trials for Cardiovascular Disease
Active, not recruitingPhase 3
ENDOTHELION Study Group: Effect of Bosentan in NAION Patients
Ischemic Optic Neuropathy
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janelle Cortner, Ph.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Disease, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. 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 8 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00339599, which also lists 3 linked publications.
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 8 Nov 2019.