Overview

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 Blood will be withdrawn into multiple syringes or tubes.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

• INCLUSION CRITERIA 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

  1. Males or females of age greater than or equal to 18 years old.
  2. 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)

        EXCLUSION CRITERIA 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
          1. Hemoglobin <7.0 g/dL
          2. 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*
          3. 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.
        INCLUSION CRITERIA FOR SUBJECTS WHO ARE TO RECEIVE CRRT (IRRESPECTIVE OF DIAGNOSIS) IN WHOM
        THE TOTAL AMOUNT OF PROTOCOL RELATED BLOOD WILL NOT EXCEED 8 ML.
          1. Males or females of age greater than or equal to 18 years old.
          2. 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)
        EXCLUSION CRITERIA FOR SUBJECTS WHO ARE TO RECEIVE CRRT (IRRESPECTIVE OF DIAGNOSIS) IN WHOM
        THE TOTAL AMOUNT OF PROTOCOL RELATED BLOOD WILL NOT EXCEED 8 ML)
          1. Hemoglobin <7.0 g/dL
          2. 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.
        INCLUSION CRITERIA FOR HEALTHY VOLUNTEERS:
          1. Males or females of age greater than or equal to 18 years old
          2. Ability of subjects to understand and the willingness to sign an informed consent
             document.
        EXCLUSION CRITERIA FOR HEATLHY VOLUNTEERS:
          1. Blood or platelet donation within the last 6 weeks.
          2. 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)
          3. History of recreational drug use with the exception of marijuana (as long as marijuana
             use was >3 months from the time of study screening).
          4. Active acute illness (i.e viral syndrome). Subjects may return for evaluation at a
             later date once the acute illness resolves.
          5. 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.).