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

Sponsor

National Institutes of Health Clinical Center (CC) (NIH)

Overall Status

Recruiting

CT.gov ID

NCT03253705

Collaborator

(none)

1,000

Enrollment

Location

118.5

Anticipated Duration (Months)

8.4

Patients Per Site Per Month

Study Details

Study Description

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 Blood will be withdrawn into multiple syringes or tubes.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

Condition or Disease	Intervention/Treatment	Phase
Endothelial Dysfunction Inflammation in Cardiopulmonary and Vascular Disease States Healthy Volunteers

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

1000 participants

Observational Model:

Other

Time Perspective:

Other

Official Title:

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

Actual Study Start Date :

Sep 14, 2017

Anticipated Primary Completion Date :

Aug 1, 2027

Anticipated Study Completion Date :

Aug 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Controls Healthy Controls
Research Subjects Research Subjects already enrolled on other NIH protocols

Outcome Measures

Primary Outcome Measures

Exploratory assay development [10 years]
Development of new assays

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)

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

Hemoglobin <7.0 g/dL
Currently receiving infusion of any dosage of norepinephrine, vasopressin, or epinephrine; or dopamine at an infusion rate >2.5

micro g/kg/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.

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.

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)

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)

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.

INCLUSION CRITERIA FOR HEALTHY VOLUNTEERS:

Males or females of age greater than or equal to 18 years old
Must be able to provide informed, written consent.

EXCLUSION CRITERIA FOR HEATLHY VOLUNTEERS:

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.).