Blood Vessel Study

NCT01524549 | Completed

• 2 other identifiers: 12006112-E-0061
• Study Type: observational
• Target: 178
• Locations: 1 country
• Sites: 1

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:

• 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....

Conditions

Cardiovascular Disease

Keywords

Cardiovascular; P450s; Flow-Mediated Dilation; Brachial Artery Ultrasound; Endothelial Cell Function; Natural History; Healthy Volunteer; HV

Outcome Measures

Primary 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

  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@...

  analysis

Study Arms (5)

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Genotype data from the EPR will be used to identify potential study participants@@@@@@

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• National Institute of Environmental Health Sciences (NIEHS): lead

Study Sites (1)

NIEHS Clinical Research Unit (CRU)

Research Triangle Park, North Carolina, United States

Location

Related Publications (3)

• 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.

  PMID: 19788058 BACKGROUND

• Arking 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.

  PMID: 19716196 BACKGROUND

• Campbell 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.

  PMID: 8593700 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Darryl C Zeldin, M.D.

  National Institute of Environmental Health Sciences (NIEHS)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2012
• First Posted: February 2, 2012
• Study Start: March 1, 2012
• Last Updated: July 28, 2026

Record last verified: 2025-09-18

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)