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

 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 Blood will be withdrawn into multiple syringes or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...
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.
-  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 any dosage of norepinephrine, vasopressin, or
 epinephrine; or dopamine at an infusion rate >2.5

 micro g/kg/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.

 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 EXCEE 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. Must be able to provide informed, written consent.

 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.).