Endothelial DysfunctionNCT03253705
Samples From Human Subjects to Facilitate Basic, Translational and Clinical Research
An observational study of Endothelial Dysfunction and Inflammation in Cardiopulmonary and Vascular Disease States, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial summary
Background: This study is designed to provide samples to help us study the genes your blood cells are making as well as the proteins, sugars, fats, vitamins and other metabolites found in your blood or urine. Blood samples may also be collected to make special cells. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Endothelial Dysfunction, Inflammation in Cardiopulmonary and Vascular Disease States, Healthy Volunteers
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2017to 1 Aug 2037
- Phase
- Observational
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 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy Volunteers who donate samples of assay development and Research Subjects who donate samples of assay development.
Who may be able to join
- Males or females of age greater than or equal to 18 years old
- Ability of subjects to understand and the willingness to sign an informed consent document.
Who cannot join
- Blood or platelet donation within the last 6 weeks.
- Hemoglobin below normal (e.g. below 11.2 g/dl for females and below 13.7 mg/dl for males at the NIH CC); subjects may return for evaluation at a later date. (After initial enrollment, hematocrit does not need to be done prior to subsequent blood draws unless there is interval development of symptomatic anemia)
- History of recreational drug use with the exception of marijuana (as long as marijuana use was >3 months from the time of study screening).
- Active acute illness (i.e viral syndrome). Subjects may return for evaluation at a later date once the acute illness resolves.
- Volunteers may be excluded if in the opinion of the study investigators they have a condition that may adversely affect the outcome of the study or the safety of the volunteer, such as, active tobacco use (> 6 months) in the past ten years, any tobacco use within 3 months prior to the screening evaluation, a history of clinically relevant and active cardiopulmonary disease (e.g. Including but not limited to any cardiopulmonary diseases not well controlled by medications, EKG with evidence of clinically relevant heart disease, COPD with hypoxemia and forced expiratory volume/forced vital capacity (FEV1/FVC) > 2 standard deviations from normal, etc.).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY8664111010, prpl@cc.nih.gov
About this study
Official title: Obtaining Samples From Human Subjects to Facilitate Basic, Translational and Clinical Research
Background:
This study is designed to provide samples to help us study the genes your blood cells are making as well as the proteins, sugars, fats, vitamins and other metabolites found in your blood or urine. Blood samples may also be collected to make special cells. These are called induced pluripotent stem cells or iPSCs. Pluripotent stem cells are cells that can be converted into any type of cell. Researchers want to study in the lab iPSCs that are derived from blood samples.
Read more
Objective:
To collect samples to help study genes, proteins, sugars, fats, vitamins, and other metabolites found in blood or urine.
Eligibility:
Healthy volunteers and patients ages 18 and older
Design:
First-time research study participants at NIH will have an initial visit for this study that should last no more than 1 hour. All other visits should last 20 30 minutes.
Participants will undergo a limited history and physical exam.
Participants may have routine blood and urine tests.
If participants are giving a blood sample, they must have a hemoglobin level checked in the past 12 months to make sure it is safe for them to give a blood sample for research.
Participants may have a venous blood collection. They may do this at several visits. They will lie on a recliner or couch or sit in a chair. A needle will be placed into a vein in the hand or arm, using sterile techniques. Blood will be withdrawn into multiple syringes or tubes.
Participants may be asked to provide urine in an appropriate container...
Read the detailed description
Our department is evaluating various aspects of the cardiovascular system and/or endothelial dysfunction and/or inflammation in disease states, such as, but not limited to, pulmonary hypertension (PH) and other pulmonary vascular diseases, arteriosclerosis, transplantation, inflammatory processes and sepsis. The collection of human blood and urine from both research subjects and healthy volunteers is necessary for the development of relevant laboratory assays and protocols, and to further research studies requiring such evaluations. In research subjects undergoing renal replacement therapy who produce limited urine we may also sample ultrafiltrate as a surrogate for urine. This protocol defines in general terms the purposes for which blood, urine and ultrafiltrate will be collected by members of the NIH s Clinical Center (CC), Critical Care Medicine Department (CCMD) and collaborating institutions and establishes general conditions under which sampling will be performed.
- Conditions
- Endothelial Dysfunction, Inflammation in Cardiopulmonary and Vascular Disease States, Healthy Volunteers
- Keywords
- Assay Development, Gene Expression, Metabolomics, Induced Pluripotent Stem Cells, PBMCs/DNA/RNA, Natural History
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 |
|---|---|---|
| Controls | Healthy Controls | |
| Research Subjects | Research Subjects already enrolled on other NIH protocols |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exploratory assay development
Development of new assays
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2017
- Study start14 Sep 2017
- Primary completion1 Aug 2037 (estimated)
- Study completion1 Aug 2037 (estimated)
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 Endothelial DysfunctionStudies 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
- Other
- Time perspective
- Other
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Michael A Solomon, M.D., Principal investigator, National Institutes of Health Clinical Center (CC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03253705
- Sponsor's protocol ID
- 170148
- Other IDs
- 17-CC-0148
- Status last verified
- 21 Oct 2026
- First submitted
- 17 Aug 2017
- Last updated
- 23 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lewis GD, Ngo D, Hemnes AR, Farrell L, Domos C, Pappagianopoulos PP, Dhakal BP, Souza A, Shi X, Pugh ME, Beloiartsev A, Sinha S, Clish CB, Gerszten RE. Metabolic Profiling of Right Ventricular-Pulmonary Vascular Function Reveals Circulating Biomarkers of Pulmonary Hypertension. J Am Coll Cardiol. 2016 Jan 19;67(2):174-189. doi: 10.1016/j.jacc.2015.10.072.
PubMed 26791065Li H, Tu H, Wang Y, Levine M. Vitamin C in mouse and human red blood cells: an HPLC assay. Anal Biochem. 2012 Jul 15;426(2):109-17. doi: 10.1016/j.ab.2012.04.014. Epub 2012 Apr 20.
PubMed 22522059Quintana-Bustamante O, Segovia JC. Generation of Patient-Specific induced Pluripotent Stem Cell from Peripheral Blood Mononuclear Cells by Sendai Reprogramming Vectors. Methods Mol Biol. 2016;1353:1-11. doi: 10.1007/7651_2014_170.
PubMed 25523810