Blood Vessel Study
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ClinicalTrials.gov Identifier: NCT01524549 |
Recruitment Status
:
Enrolling by invitation
First Posted
: February 2, 2012
Last Update Posted
: October 19, 2017
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Tracking Information | ||||
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First Submitted Date | February 1, 2012 | |||
First Posted Date | February 2, 2012 | |||
Last Update Posted Date | October 19, 2017 | |||
Study Start Date | January 17, 2012 | |||
Primary Completion Date | Not Provided | |||
Current Primary Outcome Measures |
Flow-mediated dilation (FMD; endothelium-dependent vasodilation), defined as the peak percent change in brachial artery diameter, relative to baseline, after reactive hyperemia, as measured by ultrasound | |||
Original Primary Outcome Measures | Not Provided | |||
Change History | Complete list of historical versions of study NCT01524549 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures | Not Provided | |||
Original Secondary Outcome Measures | Not Provided | |||
Current Other Outcome Measures | Not Provided | |||
Original Other Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title | Blood Vessel 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 | |||
Brief 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. 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:
Design:
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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 Type | Observational | |||
Study Design | Observational Model: Cohort Time Perspective: Cross-Sectional |
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Target Follow-Up Duration | Not Provided | |||
Biospecimen | Not Provided | |||
Sampling Method | Not Provided | |||
Study Population | Not Provided | |||
Condition | Endothelial Cell Function | |||
Intervention | Not Provided | |||
Study Groups/Cohorts | Not Provided | |||
Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status | Enrolling by invitation | |||
Actual Enrollment |
172 | |||
Original Estimated Enrollment |
180 | |||
Study Completion Date | Not Provided | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria |
EXCLUSION CRITERIA:
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. |
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Sex/Gender |
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Ages | 18 Years to 70 Years (Adult, Senior) | |||
Accepts Healthy Volunteers | Yes | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT01524549 | |||
Other Study ID Numbers | 120061 12-E-0061 |
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Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | National Institutes of Health Clinical Center (CC) ( National Institute of Environmental Health Sciences (NIEHS) ) | |||
Study Sponsor | National Institute of Environmental Health Sciences (NIEHS) | |||
Collaborators | Not Provided | |||
Investigators |
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PRS Account | National Institutes of Health Clinical Center (CC) | |||
Verification Date | June 14, 2017 |