Longitudinal Study of Multi-Analyte Profile 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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
|Official Title:||Determining Cardiovascular Health Using a Multi-Analyte Profile in a Longitudinal Study of a Statin Intervention for Dyslipidemia|
- Comparison of 29 specific cardiovascular related lab assays from baseline through a period of 6 months in a control population with dyslipidemia vs a study group with dyslipidemia receiving an FDA approved Statin (Pravastatin). [ Time Frame: 6-month ] [ Designated as safety issue: No ]Comparative, predictive capability of a single versus panel versus multi-analyte profile for improvement in cardiovascular health as a function of therapeutic intervention over time. Comparative analyses will be performed against the control profile to track blood chemistry changes as a result of intervention.
- Limited time-course of different stages of disease regression [ Time Frame: 6-month ] [ Designated as safety issue: No ]
|Study Start Date:||June 2011|
|Estimated Study Completion Date:||April 2012|
|Primary Completion Date:||April 2012 (Final data collection date for primary outcome measure)|
No Intervention: Control Group
Active Comparator: Statin
40mg or 80mg dose 28 days for 6 month period
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.
|United States, North Carolina|
|Wake Research Associates|
|Raleigh, North Carolina, United States, 27617|
|Principal Investigator:||Wayne Harper, MD||Wake Research Associates|
|Study Director:||Stephen Naylor, Ph.D.||MaiHealth Inc|