Endothelial Dysfunction, Healthy Volunteers, Inflammation in Cardiopulmonary and Vascular Disease States
Conditions
Keywords
Assay Development, Gene Expression, Metabolomics, Induced Pluripotent Stem Cells, PBMCs/DNA/RNA, Natural History
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 Blood will be withdrawn into multiple syringes or tubes.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...
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.
Interventions
None listed
Sponsors
National Institutes of Health Clinical Center (CC)
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes
Inclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Exploratory assay development | 10 years | Development of new assays |
Countries
United States
Contacts
CONTACTGrace M Graninger, R.N.
CONTACTMichael A Solomon, M.D.
PRINCIPAL_INVESTIGATORMichael A Solomon, M.D.
National Institutes of Health Clinical Center (CC)
Outcome results
None listed