Dried Blood Spot- Statin Pilot Study

NCT02402803 | Terminated

• 1 other identifier: Pro00037026
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Cardiovascular disease (CVD) is the number one cause of mortality for men and women in the United States. Dyslipidemia, particularly a high low-density-lipoprotein cholesterol (LDL-C) level, is a well-established cardiovascular risk factor and the current American Heart Association guideline for CVD risk assessment recommends a lipid panel to be checked. In addition, guidelines recommend statin therapy in all patients with clinical atherosclerotic CVD, all patients with LDL-C = 190 mg/dL, patients age 40-75 years with diabetes and LDL-C 70-189 mg/dL, and patients with an estimated 10-year atherosclerotic CVD risk = 7.5%. For all of these patients, a fasting lipid panel should be drawn prior to statin initiation as well as during follow-up to assess medication and lifestyle adherence. These fasting lipid panels are obtained via conventional phlebotomy via venopuncture in an office-based or hospital laboratory setting. However, research protein quantitation with mass spectrometry and enzyme-linked immunosorbent assay (ELISA) are technologies that allow for sensitive quantitation of protein biomarkers and targets, including lipoproteins. Most importantly, multiple reaction monitoring (MRM) mass spectrometry is able to assess samples from a dried blood spot (DBS), whose advantages include minimal volume requirements, ease of sample attainment by finger stick with minimal training required, ease of transport, and sample stability. The purpose of the proposed analysis is to 1) measure changes in CVD biomarkers before and after initiation of statin therapy and 2) compare lipid measurements by conventional phlebotomy blood samples to research protein quantitation measurements in DBS and plasma.

Conditions

Hyperlipidemias; Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

• Clinical lipid and research protein measurements (composite)

  Compare LDL-C and HDL-C clinical laboratory test measurements in serum vs Apo B and ApoA-I research protein measurements in DBS and plasma as to correlation coefficient across subject samples and level of response (expected reduction) in LDL/Apo B following initiation of statin therapy

  up to 4-6 week follow-up

Secondary Outcomes (3)

• Biomarker change

  Baseline and 4-6 week follow-up

• Research protein measurements in dried blood spot vs plasma

  Baseline and 4-6 week follow-up

• Clinical Cardiovascular Risk Score

  Baseline

Interventions

Dried blood spot testing and phlebotomy OTHER

At baseline and 4-6 week follow-up, a phlebotomy serum sample (5 ml) will be collected in one golden-top tube for clinical laboratory measurement of cholesterol (total cholesterol, LDL-C, triglycerides, HDL-C) . During the same phlebotomy, a fingerprick dried blood spot (DBS) sample and two lavender EDTA plasma tubes (5 ml each) will be collected for analysis of CVD protein markers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Men and women age\> 18 years who are initiated on statin therapy in the clinical setting

You may qualify if:

• \. Men and women age\> 18 years who are initiated on statin therapy in the clinical setting.

You may not qualify if:

• History of rhabdomyolysis
• History of prior allergic reaction to statins
• History of liver failure
• Contraindications to antecubital phlebotomy or finger stick (including those with bilateral dialysis AV fistulae).

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

cholesterol panel (total cholesterol, LDL-C, triglycerides, HDL-C), Apo A-I, Apo B, Apo E, IgM, plasminogen, TIMP-1, Von Willebrand factor, antithrombin III, cystatin C, mesothelin, C-reactive protein, SAA, LPS-binding protein, mannose-binding lectin, myeloperoxidase, fibrinogen, alpha-1-acid glycoprotein, soluble transferrin receptor, haptoglobin.

MeSH Terms

Conditions

Hyperlipidemias; Cardiovascular Diseases

Interventions

Dried Blood Spot Testing; Phlebotomy

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Blood Specimen Collection; Specimen Handling; Punctures; Therapeutics; Surgical Procedures, Operative

Study Officials

• C. Noel Bairey Merz, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 25, 2015
• First Posted: March 30, 2015
• Study Start: October 1, 2015
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2020
• Last Updated: October 8, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1)