Cardiovascular DiseaseNCT01524549
Blood Vessel Study
An observational study of Cardiovascular Disease, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site in United States.
Trial summary
Background: The endothelium is the inner lining of blood vessels. The cells in this lining help regulate blood flow and immune system function. Problems with endothelial cells can contribute to heart disease, high blood pressure, and diabetes. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cardiovascular Disease
- How many people
- 178 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2012to not given
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Genotype data from the EPR will be used to identify potential study participants@@@@@@
Who may be able to join
- Participant of the Environmental Polymorphisms Registry and current contact information available
- Genotype information available for relevant CYP2J2 and EPHX2 polymorphisms, which indicates:
- WT for EPHX2 K55R and WT for CYP2J2 7
- WT for EPHX2 K55R and heterozygous for CYP2J2 7
- WT for EPHX2 K55R and homozygous for CYP2J2 7
- WT for CYP2J2 7 and heterozygous for EPHX2 K55R (N=30)
Show all 10Show fewer
- WT for CYP2J2 7 and homozygous for EPHX2 K55R (N=30)
- Age 18-70 years
- Willing and able to provide informed consent
- Able to comply with all protocol procedures
Who cannot join
- Currently pregnant or breast feeding
- Hospitalized for a cardiovascular disease or stroke event within the previous 3 months
- Current use of long-acting nitrates (e.g., isosorbide mononitrate, isosorbide dinitrate)
- Current use of medications taken for hypertension.
- For participants with current daily or chronic use of NSAIDs; unable or unwilling to refrain from taking NSAIDs for 7 days prior to enrollment visit.
- Current use of insulin for Type I Diabetes
Show all 22Show fewer
- Presence of a pacemaker or implanted cardioverter-defibrillator
- Presence of an irregular heart rhythm (atrial fibrillation) at the study visit
- Current resting heart rate <40 or >125 beats per minute
- Current systolic blood pressure <90 or >180 mmHg, or diastolic blood pressure >110 mmHg
- Skin sensitivity precluding use of ECG electrodes
- History of hypersensitivity to nitroglycerin or other nitrates or nitrites
- History of infection within the preceding 1 week or temperature >38 degrees C
- Unwilling or unable to:
- Fast (including alcohol and caffeine-containing products) and discontinue tobacco use for 12 hours prior to Visit 1
- Withhold all prescribed and over-the-counter medications and supplements the morning of Visit 1, until after the visit is completed
- Refrain from taking the following, as needed, medications for 7 days prior to Visit 1:
- Vasoactive agents, such as decongestants (e.g., pseudoephedrine)
- Recreational drugs such as marijuana, cocaine, and amphetamines
- Anti-inflammatory agents (NSAIDs), such as ibuprofen, naproxen or aspirin
- Sildenafil (Viagra), vardenafil (Levitra), and tadalafil (Cialis)
- Exclusion of Pregnant and Breast Feeding Women: Any woman who is pregnant or breast feeding will be excluded from this study because nitroglycerin, administered as part of the study, is category C, and it is unknown whether nitroglycerin can cause fetal harm when administered to a pregnant woman or whether it can affect reproductive capacity; it is also unknown whether nitroglycerin is excreted in human milk. Also, hormonal changes associated with pregnancy can significantly influence the proposed measures of endothelial function. Females will have a urine pregnancy test prior to undergoing study procedures.
Trial locations and contacts
1 site in 1 country.
United States1 site
NIEHS Clinical Research Unit (CRU)
Research Triangle Park, North Carolina
About this study
Official title: The Role of the Functionally Relevant Single Nucleotide Polymorphisms CYP2J2 -50G>T (CYP2J2 7) and EPHX2 9846A>G (EPHX2 K55R) in Human Endothelial Function
Background:
- The endothelium is the inner lining of blood vessels. The cells in this lining help regulate blood flow and immune system function. Problems with endothelial cells can contribute to heart disease, high blood pressure, and diabetes. Certain genes or parts of genes may be related to problems with endothelial function. Researchers want to study healthy adults who have genes that may affect their endothelial function. More information on these genes may provide more information on genetic risk for certain diseases.
Read more
Objectives:
- To study healthy adults who have genetic markers related to endothelial cell problems.
Eligibility:
- Healthy volunteers between 18 and 65 years of age.
- Current participants of the Environmental Polymorphisms Registry and have certain genes related to endothelial cell problems.
Design:
- Participants will have a single study visit to collect information and samples.
- Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected.
- Participants will have an ultrasound of the artery in the arm and will be given a short-acting medication called nitroglycerin to study blood flow and blood pressure.
Read the detailed description
According to the CDC, heart disease is the leading cause of death for both men and women of most racial/ethnic groups in the United States, including African Americans, Hispanics, and whites. About 610,000 people die of cardiovascular disease (CVD) every year, accounting for 1 in every 4 deaths (41). Because many known risk factors for heart disease are hereditary, understanding the connection between genetics, particularly heritable polymorphisms, and cardiovascular disease risk is of great importance. This is a cross-sectional, controlled study designed to investigate the association of two single nucleotide polymorphisms (SNPs) - a cytochrome P450 (CYP) epoxygenase gene CYP2J2 SNP, CYP2J2 7, and a soluble epoxide hydrolase (sEH) gene EPHX2 SNP encoding a K55R variant - with altered endothelial function in humans. Healthy adults, aged 18-65 years, who are either carriers of CYP2J2 7 or EPHX2 K55R, or who are wild type (WT) with respect to either SNP will be recruited into a total of five genotype groups. Potential participants will be identified from the Environmental Polymorphisms Registry, mailed an informational letter, contacted by phone and/or email, and pre-screened for eligibility. As participants are recruited, demographic characteristics (i.e., age, gender, and race/ethnicity) will be compared between the groups, and, if necessary, recruitment will be targeted to achieve an approximate match in demographic characteristics across the groups. Pre-screened individuals will provide verbal consent to refrain from taking certain as needed supplements/medications that could alter endothelial function and recreational drugs (such as marijuana, cocaine and amphetamines) prior to the study visit, and will be mailed an informed consent form, medical history form, a urine collection cup, and pre-visit instructions. Participants will attend a single study visit that will take place at the NIEHS Clinical Research Unit. During this visit, written informed consent will be obtained, and there will be a final screening and eligibility determination including medical history review, assessment of vital signs, physical examination, carbon monoxide measurement, pregnancy test (if applicable), and electrocardiogram (ECG). In eligible participants, a lipid panel will be performed and endothelial function will be assessed non-invasively by brachial artery ultrasound (i.e., flow-mediated dilation) and digital peripheral arterial tonometry. Blood and urine (first void) samples will be collected for biomarker analyses, which will be conducted in the Zeldin laboratory at NIEHS. The primary objective of the study is to determine whether individuals who are homozygous or heterozygous for the CYP2J2 7 or EPHX2 K55R SNPs exhibit altered endothelial function compared with individuals who are WT for that SNP. As a secondary objective, the impact of these two SNPs on inflammatory and CYP epoxygenase pathway biomarkers will be examined.
- Conditions
- Cardiovascular Disease
- Keywords
- Cardiovascular, P450s, Flow-Mediated Dilation, Brachial Artery Ultrasound, Endothelial Cell Function, Natural History, Healthy Volunteer, HV
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| WT for CYP2J2*7 and heterozygous for EPHX2 K55R | SNP | |
| WT for CYP2J2*7 and homozygous for EPHX2 K55R | SNP | |
| WT for EPHX2 K55R and heterozygous for CYP2J2*7 | SNP | |
| WT for EPHX2 K55R and homozygous for CYP2J2*7 | SNP | |
| WT for EPHX2 K55R and WT for CYP2J2*7 | SNP |
What is being measured
The primary outcome is the main question the study is designed to answer.
-Change in digital pulsatile pressure-Endothelium-independent vasodilation-Change in brachial artery blood flow velocity -Serum levels of inflammatory markers -Serum and urine levels of cytochrome P450 epoxygenase pathway biomarkers@...
-Change in digital pulsatile pressure-Endothelium-independent vasodilation-Change in brachial artery blood flow velocity -Serum levels of inflammatory markers -Serum and urine levels of cytochrome P450 epoxygenase pathway biomarkers
Measured: analysis
Secondary outcomes (1)
-Change in digital pulsatile pressure-Endothelium-independent vasodilation-Change in brachial artery blood flow velocity -Serum levels of inflammatory markers -Serum and urine levels of cytochrome P450 epoxygenase pathway biomarkers@...
-Change in digital pulsatile pressure-Endothelium-independent vasodilation-Change in brachial artery blood flow velocity -Serum levels of inflammatory markers -Serum and urine levels of cytochrome P450 epoxygenase pathway biomarkers
Measured: analysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2012 (estimated)
- Study start1 Mar 2012
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.
- 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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Darryl C Zeldin, M.D., Principal investigator, National Institute of Environmental Health Sciences (NIEHS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01524549
- Sponsor's protocol ID
- 120061
- Other IDs
- 12-E-0061
- Status last verified
- 30 Sep 2026
- First submitted
- 1 Feb 2012
- Last updated
- 26 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Heron M, Hoyert DL, Murphy SL, Xu J, Kochanek KD, Tejada-Vera B. Deaths: final data for 2006. Natl Vital Stat Rep. 2009 Apr 17;57(14):1-134.
PubMed 19788058Arking DE, Chakravarti A. Understanding cardiovascular disease through the lens of genome-wide association studies. Trends Genet. 2009 Sep;25(9):387-94. doi: 10.1016/j.tig.2009.07.007. Epub 2009 Aug 26.
PubMed 19716196Campbell WB, Gebremedhin D, Pratt PF, Harder DR. Identification of epoxyeicosatrienoic acids as endothelium-derived hyperpolarizing factors. Circ Res. 1996 Mar;78(3):415-23. doi: 10.1161/01.res.78.3.415.
PubMed 8593700
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of the Functionally Relevant Single Nucleotide Polymorphisms CYP2J2 -50G>T (CYP2J2 7) and EPHX2 9846A>G (EPHX2 K55R) in Human Endothelial Function
- ClinicalTrials.gov ID
- NCT01524549
- Acronym / sponsor ID
- 120061
- Conditions
- Cardiovascular Disease
- Keywords
- Cardiovascular, P450s, Flow-Mediated Dilation, Brachial Artery Ultrasound, Endothelial Cell Function, Natural History, Healthy Volunteer, HV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)US National Institutes of Health
- Study start
- 1 Mar 2012 (actual)
- First posted
- 2 Feb 2012 (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.
Background:
- The endothelium is the inner lining of blood vessels. The cells in this lining help regulate blood flow and immune system function. Problems with endothelial cells can contribute to heart disease, high blood pressure, and diabetes. Certain genes or parts of genes may be related to problems with endothelial function. Researchers want to study healthy adults who have genes that may affect their endothelial function. More information on these genes may provide more information on genetic risk for certain diseases.
Objectives:
- To study healthy adults who have genetic markers related to endothelial cell problems.
Eligibility:
- Healthy volunteers between 18 and 65 years of age.
- Current participants of the Environmental Polymorphisms Registry and have certain genes related to endothelial cell problems.
Design:
- Participants will have a single study visit to collect information and samples.
- Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected.
- Participants will have an ultrasound of the artery in the arm and will be given a short-acting medication called nitroglycerin to study blood flow and blood pressure.
Detailed description
According to the CDC, heart disease is the leading cause of death for both men and women of most racial/ethnic groups in the United States, including African Americans, Hispanics, and whites. About 610,000 people die of cardiovascular disease (CVD) every year, accounting for 1 in every 4 deaths (41). Because many known risk factors for heart disease are hereditary, understanding the connection between genetics, particularly heritable polymorphisms, and cardiovascular disease risk is of great importance. This is a cross-sectional, controlled study designed to investigate the association of two single nucleotide polymorphisms (SNPs) - a cytochrome P450 (CYP) epoxygenase gene CYP2J2 SNP, CYP2J2 7, and a soluble epoxide hydrolase (sEH) gene EPHX2 SNP encoding a K55R variant - with altered endothelial function in humans. Healthy adults, aged 18-65 years, who are either carriers of CYP2J2 7 or EPHX2 K55R, or who are wild type (WT) with respect to either SNP will be recruited into a total of five genotype groups. Potential participants will be identified from the Environmental Polymorphisms Registry, mailed an informational letter, contacted by phone and/or email, and pre-screened for eligibility. As participants are recruited, demographic characteristics (i.e., age, gender, and race/ethnicity) will be compared between the groups, and, if necessary, recruitment will be targeted to achieve an approximate match in demographic characteristics across the groups. Pre-screened individuals will provide verbal consent to refrain from taking certain as needed supplements/medications that could alter endothelial function and recreational drugs (such as marijuana, cocaine and amphetamines) prior to the study visit, and will be mailed an informed consent form, medical history form, a urine collection cup, and pre-visit instructions. Participants will attend a single study visit that will take place at the NIEHS Clinical Research Unit. During this visit, written informed consent will be obtained, and there will be a final screening and eligibility determination including medical history review, assessment of vital signs, physical examination, carbon monoxide measurement, pregnancy test (if applicable), and electrocardiogram (ECG). In eligible participants, a lipid panel will be performed and endothelial function will be assessed non-invasively by brachial artery ultrasound (i.e., flow-mediated dilation) and digital peripheral arterial tonometry. Blood and urine (first void) samples will be collected for biomarker analyses, which will be conducted in the Zeldin laboratory at NIEHS. The primary objective of the study is to determine whether individuals who are homozygous or heterozygous for the CYP2J2 7 or EPHX2 K55R SNPs exhibit altered endothelial function compared with individuals who are WT for that SNP. As a secondary objective, the impact of these two SNPs on inflammatory and CYP epoxygenase pathway biomarkers will be examined.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| WT for CYP2J2*7 and heterozygous for EPHX2 K55R | – | –SNP |
| WT for CYP2J2*7 and homozygous for EPHX2 K55R | – | –SNP |
| WT for EPHX2 K55R and heterozygous for CYP2J2*7 | – | –SNP |
| WT for EPHX2 K55R and homozygous for CYP2J2*7 | – | –SNP |
| WT for EPHX2 K55R and WT for CYP2J2*7 | – | –SNP |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Genotype data from the EPR will be used to identify potential study participants@@@@@@
Key inclusion criteria (10 listed)
- Participant of the Environmental Polymorphisms Registry and current contact information available
- Genotype information available for relevant CYP2J2 and EPHX2 polymorphisms, which indicates:
- Age 18-70 years
- Willing and able to provide informed consent
- Able to comply with all protocol procedures
Key exclusion criteria (22 listed)
- Currently pregnant or breast feeding
- Hospitalized for a cardiovascular disease or stroke event within the previous 3 months
- Current use of long-acting nitrates (e.g., isosorbide mononitrate, isosorbide dinitrate)
- Current use of medications taken for hypertension.
- For participants with current daily or chronic use of NSAIDs; unable or unwilling to refrain from taking NSAIDs for 7 days prior to enrollment visit.
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
-Change in digital pulsatile pressure-Endothelium-independent vasodilation-Change in brachial artery blood flow velocity -Serum levels of inflammatory markers -Serum and urine levels of cytochrome P450 epoxygenase pathway biomarkers@...
Time frame: analysis
-Change in digital pulsatile pressure-Endothelium-independent vasodilation-Change in brachial artery blood flow velocity -Serum levels of inflammatory markers -Serum and urine levels of cytochrome P450 epoxygenase pathway biomarkers
1 secondary outcome
-Change in digital pulsatile pressure-Endothelium-independent vasodilation-Change in brachial artery blood flow velocity -Serum levels of inflammatory markers -Serum and urine levels of cytochrome P450 epoxygenase pathway biomarkers@...
Time frame: analysis
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 26 Oct 2026.
- Background: PubMed 19788058Heron M, Hoyert DL, Murphy SL, Xu J, Kochanek KD, Tejada-Vera B. Deaths: final data for 2006. Natl Vital Stat Rep. 2009 Apr 17;57(14):1-134.
- Background: PubMed 19716196Arking DE, Chakravarti A. Understanding cardiovascular disease through the lens of genome-wide association studies. Trends Genet. 2009 Sep;25(9):387-94. doi: 10.1016/j.tig.2009.07.007. Epub 2009 Aug 26.
- Background: PubMed 8593700Campbell WB, Gebremedhin D, Pratt PF, Harder DR. Identification of epoxyeicosatrienoic acids as endothelium-derived hyperpolarizing factors. Circ Res. 1996 Mar;78(3):415-23. doi: 10.1161/01.res.78.3.415.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Darryl C Zeldin, M.D. principal investigator
National Institute of Environmental Health Sciences (NIEHS)
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 Institute of Environmental Health Sciences (NIEHS) 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 10 inclusion and 22 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 26 Oct 2026. 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.
What does the primary outcome measure?
-Change in digital pulsatile pressure-Endothelium-independent vasodilation-Change in brachial artery blood flow velocity -Serum levels of inflammatory markers -Serum and urine levels of cytochrome P450 epoxygenase pathway biomarkers@... (time frame: analysis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01524549, 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 26 Oct 2026.