Samples From Human Subjects to Facilitate Basic, Translational and Clinical Research

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorNational Institutes of Health Clinical Center (CC)

About this trial

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 Blood will be withdrawn into multiple syringes or tubes.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

Eligibility criteria

Qualifiers

FOR RESEARCH SUBJECTS WITH DISEASES RELATED TO CARDIOVASCULAR SYSTEM AND/OR INFLAMMATION AND/OR ENDOTHELIAL DYSFUNCTION SUCH AS BUT NOT LIMITED TO ARTERIOSCLEROSIS, TRANSPLANTATION, PULMONARY HYPERTENSION, OTHER ADVANCED LUNG OR HEART DISEASE

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)

Disqualifiers

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.)

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

1,000 Participants
are grouped into 2 trial groups