Longitudinal Study of Multi-Analyte Profile for Dyslipidemia

Not Applicable

• Conditions: Dyslipidemia
• Interventions: Drug: Pravastatin

• Registration Number: NCT01441908
• Lead Sponsor: MaiHealth Inc

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-09-21
• Study First Submitted QC: 2011-09-26
• Study First Posted: 2011-09-28
• Status Verified: 2012-04
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Last Update Submitted: 2012-04-13
• Last Update Posted: 2012-04-16

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Sign and Date IRB approved consent form
• 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

• Have a body Mass Index (BMI) > or = 35
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Statin	Pravastatin	Receiving Statin

Primary Outcome Measures

Name	Time	Method
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).	6-month	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.

Secondary Outcome Measures

Name	Time	Method
Limited time-course of different stages of disease regression	6-month

Trial Locations

Locations (1)

Wake Research Associates; 🇺🇸 Raleigh, North Carolina, United States