Blood Vessel Study (NCT01524549) | Clinical Trial Compass
CompletedNot Applicable
Blood Vessel Study
United States178 participantsStarted 2012-03-01
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* INCLUSION CRITERIA:
* 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
EXCLUSION CRITERIA:
* 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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
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@...
Timeframe: analysis
Trial details
NCT IDNCT01524549
SponsorNational Institute of Environmental Health Sciences (NIEHS)