NCT03253705

Brief 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. 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. 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 Blood will be withdrawn into multiple syringes or tubes.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...

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
15mo left

Started Sep 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress88%
Sep 2017Aug 2027

First Submitted

Initial submission to the registry

August 17, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 18, 2017

Completed
27 days until next milestone

Study Start

First participant enrolled

September 14, 2017

Completed
9.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

April 24, 2026

Status Verified

November 20, 2025

Enrollment Period

9.9 years

First QC Date

August 17, 2017

Last Update Submit

April 23, 2026

Conditions

Endothelial DysfunctionHealthy VolunteersInflammation in Cardiopulmonary and Vascular Disease States

Keywords

Assay DevelopmentGene ExpressionMetabolomicsInduced Pluripotent Stem CellsPBMCs/DNA/RNANatural History

Outcome Measures

Primary Outcomes (1)

  • Exploratory assay development

    Development of new assays

    10 years

Study Arms (2)

Controls

Healthy Controls

Research Subjects

Research Subjects already enrolled on other NIH protocols

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy Volunteers who donate samples of assay development and Research Subjects who donate samples of assay development.

You may qualify if:

  • Males or females of age greater than or equal to 18 years old.
  • Subjects unable to provide informed consent must have a surrogate decision maker or another legally authorized representative (such as a legal guardian or holder of the DPA)

You may not qualify if:

  • Hemoglobin \<7.0 g/dL
  • Currently receiving infusion of epinephrine; or dopamine at an infusion rate of \>2.5 microgram/kg/min, norepinephrine of \> 20mcg/min, or vasopressin \> 0.04 units/min\*
  • In the presence of known coronary artery disease (CAD) a systolic blood pressure (SBP) \<90 mmHg. In the absence of known CAD a SBP \<80 mmHg or mean arterial pressure (MAP) \<60 mmHg with or without vasopressors\*.
  • For critically ill patients with shock (on vasopressors), no more than 20mL of blood may be obtained within a 24 hour period. (No more than 200ml over eight weeks.)
  • Research subjects 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.
  • Males or females of age greater than or equal to 18 years old.
  • Subjects unable to provide informed consent must have a surrogate decision maker or another legally authorized representative (such as a legal guardian or holder of the DPA)
  • Hemoglobin \<7.0 g/dL
  • In the presence of known coronary artery disease (CAD) a systolic blood pressure (SBP) \<90 mmHg. In the absence of known CAD a SBP \<80 mmHg or mean arterial pressure (MAP) \<60 mmHg.
  • 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.
  • 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.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Publications (3)

  • 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.

    PMID: 26791065BACKGROUND

  • Li 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.

    PMID: 22522059BACKGROUND

  • Quintana-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.

    PMID: 25523810BACKGROUND

Related Links

Study Officials

  • Michael A Solomon, M.D.

    National Institutes of Health Clinical Center (CC)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Grace M Graninger, R.N.

CONTACT

(301) 496-9320ggraninger@cc.nih.gov

Michael A Solomon, M.D.

CONTACT

(301) 496-9320msolomon@cc.nih.gov

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2017

First Posted

August 18, 2017

Study Start

September 14, 2017

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

April 24, 2026

Record last verified: 2025-11-20

Locations

US(1)