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NCT02402803 · ClinicalTrials.gov registry record
Dried Blood Spot- Statin Pilot Study
A clinical trial, sponsored by Cedars-Sinai Medical Center.
- Terminated
- Registry status
- 20
- Enrollment target
NCT02402803 is a clinical trial that was terminated before completion, run by Cedars-Sinai Medical Center. The registered enrollment target is 20 participants.
The verdict
NCT02402803 was terminated before completion, sponsored by Cedars-Sinai Medical Center.
- TERMINATED
- Registry status
- 20 participants
- Enrollment target
Study 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.
Interventions
- OTHER Dried blood spot testing and phlebotomy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2015-10 |
| Est. Completion | 2020-10 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02402803
The ClinicalTrials.gov registry entry for NCT02402803 describes a study currently listed as terminated, categorized as an unspecified phase. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cedars-Sinai Medical Center, which has 339 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Dried blood spot testing and phlebotomy is the first listed.
NCT02402803 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02402803 about?
NCT02402803 is a clinical study titled "Dried Blood Spot- Statin Pilot Study". 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...
What is the current status of trial NCT02402803?
This trial is currently terminated. The enrollment target is 20 participants. The study started on 2015-10. Estimated completion is 2020-10.
What interventions are being tested in trial NCT02402803?
The interventions under investigation include: Dried blood spot testing and phlebotomy (OTHER).
Who is sponsoring clinical trial NCT02402803?
This trial is sponsored by Cedars-Sinai Medical Center, which has 339 total clinical trials registered on ClinicalTrials.gov.
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