Longitudinal Study of Multi-Analyte Profile for Dyslipidemia
NCT ID: NCT01441908
Last Updated: 2012-04-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2011-06-30
2012-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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Control Group
Control Group
No interventions assigned to this group
Statin
Receiving Statin
Pravastatin
40mg or 80mg dose 28 days for 6 month period
Interventions
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Pravastatin
40mg or 80mg dose 28 days for 6 month period
Eligibility Criteria
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Inclusion Criteria
* Be between 30-65 years of age as of date of consent
* Have a total cholesterol value of 200-300 (units)
* Have an LDL cholesterol value of \> 100 (units)
* Able to speak and understand English
* Willing and able to participate for the 6 months required by the study
* Willing and able to provide fasting blood specimens
* Women of child-bearing potential must have a negative pregnancy test at screening
* Medically (appropriate) eligible to take the statin as determined by PI
Exclusion Criteria
* Pregnant (or planning to become pregnant during the course of the study)
* Currently taking a statin or discontinued taking a statin within 9 months of the date of screening
30 Years
65 Years
ALL
No
Sponsors
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MaiHealth Inc
OTHER
Responsible Party
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Principal Investigators
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Wayne Harper, MD
Role: PRINCIPAL_INVESTIGATOR
Wake Research Associates
Stephen Naylor, Ph.D.
Role: STUDY_DIRECTOR
MaiHealth Inc
Locations
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Wake Research Associates
Raleigh, North Carolina, United States
Countries
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Other Identifiers
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6R44HL082382-0
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
MAI-001
Identifier Type: -
Identifier Source: org_study_id
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