What this study is
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 Blood will be withdrawn into multiple syringes or tubes.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...
Study details
- Official title
- Obtaining Samples From Human Subjects to Facilitate Basic, Translational and Clinical Research
- Sponsor
- National Institutes of Health Clinical Center (CC)
- Conditions
- Endothelial Dysfunction · Inflammation in Cardiopulmonary and Vascular Disease States · Healthy Volunteers
- Enrolling
- 1,000 people
- Starts
- 2017-09-14
- Est. completion
- 2037-08-01
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 100 YearsSex ALLHealthy volunteers AcceptedAll participants
You may qualify if
- 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; 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)
- FOR SUBJECTS WHO ARE TO RECEIVE CRRT (IRRESPECTIVE OF DIAGNOSIS) IN WHOM THE TOTAL AMOUNT OF PROTOCOL RELATED BLOOD WILL NOT EXCEED 8 ML.
- 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 can't join if
- 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
- 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.
- FOR SUBJECTS WHO ARE TO RECEIVE CRRT (IRRESPECTIVE OF DIAGNOSIS) IN WHOM THE TOTAL AMOUNT OF PROTOCOL RELATED BLOOD WILL NOT EXCEED 8 ML)
- 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.
- 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.
- 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.).
HEALTHY VOLUNTEERS
You may qualify if
- 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.
You can't join if
- 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.
- 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.).
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openNational Institutes of Health Clinical Center
Bethesda, Maryland, United States
- For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) · Contact800-411-1222 ext. TTY8664111010prpl@cc.nih.gov
Recruiting
Study team
Sponsor
National Institutes of Health Clinical Center (CC)
Study ID 170148
Principal investigator
Michael A Solomon, M.D.
National Institutes of Health Clinical Center (CC)
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.