Dried Blood Spot- Statin Pilot Study

Stopped early

Conditions studied: Hyperlipidemias, Cardiovascular Diseases

In brief

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.

Key facts

Study ID

NCT02402803

Run by

Cedars-Sinai Medical Center

People needed

20

Starts

2015-10-01

Expected to finish

2020-10-01

Last updated by the study team

2020-10-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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).

Where it is running

• Cedars Sinai Medical Center — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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