Dyslipidemia Clinical Trial
Official title:
Determining Cardiovascular Health Using a Multi-Analyte Profile in a Longitudinal Study of a Statin Intervention for Dyslipidemia
The primary objective of this study is to determine any changes in cardiovascular risk among individuals receiving a statin by assessing their multi-analyte profile.
Over the past decade there has been a growing debate about the clinical value content of a
single individual diagnostic indicator of disease onset, progression or therapeutic
intervention. In particular there has been a discussion about the comparative value of a
single biomarker versus a panel (3-6 different analytes) versus a multi-analyte profile (>10
different analytes) of biomarkers to provide high content clinical information about a
specific disease onset, progression, remediation or treatment efficacy.
With the advent of personalized medicine, and recognition of the high degree of biological
variability in human pathobiology, it is important to understand the comparative value of a
single biomarker/diagnostic versus a panel versus a profile. In addition, the growth of
Preventive Medicine has spurred the development of "Wellness" in individual patients, and
the necessity for understanding and measuring the transition from a state of health
(wellness) to ultimately a state of full blown disease onset. This complex process occurs
via a multitude of biological pathways and networks and manifests at a biochemical and
clinical systems level.
In a previous study currently being analyzed, MaiHealth measured a Multi-Analyte Profile of
approximately 800 patients consisting of 400 cardiovascular compromised individuals and 400
control patients. This preliminary study was a single time point only, in which 25
individual analytes were measured as well as 3 calculated ratios or values for the 800
individuals.
The current study is a small cohort time course study over 6 months involving therapeutic
intervention with an FDA-approved statin.
The overall goal of the study is to determine the predictive capability of a single versus
panel versus multi-analyte profile set of biomarkers in cardiovascular compromised patients
with therapeutic intervention. The ultimate application of this research is information
delivery and behavioral intervention.
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Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening
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