Collecting blood and urine samples for research on cardiovascular health

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

This study is collecting blood and urine samples from healthy people and patients to see how certain biological markers relate to heart health and inflammation.

Quick facts

• Study type: Observational
• Enrollment: 1000 (estimated)
• Ages: 18 Years to 100 Years
• Sex: All
• Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
• Locations: 1 site (Bethesda, Maryland)
• Trial ID: NCT03253705 on ClinicalTrials.gov

What this trial studies

This observational study aims to collect blood and urine samples from healthy volunteers and patients to analyze gene expression, proteins, metabolites, and other biological markers related to cardiovascular health and inflammation. Participants will undergo a brief initial visit for a history and physical exam, followed by routine blood and urine tests. The samples will be used to develop laboratory assays and protocols that can further research into conditions like pulmonary hypertension and arteriosclerosis.

Who should consider this trial

Good fit: Ideal candidates include healthy volunteers and patients aged 18 and older with cardiovascular conditions or inflammation.

Not a fit: Patients with severe anemia or those currently receiving high doses of certain medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this research could lead to improved understanding and treatment of cardiovascular diseases and related inflammatory conditions.

How similar studies have performed: Other studies focusing on blood and urine sample analysis for cardiovascular research have shown promise, indicating that this approach is supported by previous findings.

Eligibility 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)

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.).

Where this trial is running

Bethesda, Maryland

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)

Study contacts

• Principal investigator: Michael A Solomon, M.D. — National Institutes of Health Clinical Center (CC)
• Study coordinator: Grace M Graninger, R.N.

Conditions Endothelial Dysfunction; Inflammation in Cardiopulmonary and Vascular Disease States; Healthy Volunteers; Assay Development; Gene Expression; Metabolomics; Induced Pluripotent Stem Cells; PBMCs/DNA/RNA