Clinical trial NCT01441908: Longitudinal Study of Multi-Analyte Profile for Dyslipidemia
Official title: Determining Cardiovascular Health Using a Multi-Analyte Profile in a Longitudinal Study of a Statin Intervention for Dyslipidemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dyslipidemia
Keywords: Cardiovascular
Multi-analyte
Statin
Dyslipidemia
Lead sponsor: MaiHealth Inc
Sponsor class: OTHER
First posted: 2011-09-28
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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).
timeFrame: 6-month
Secondary outcomes:
measure: Limited time-course of different stages of disease regression
timeFrame: 6-month
Other outcomes:
Locations:
city: Raleigh
country: United States
facility: Wake Research Associates
state: North Carolina
Study officials:
affiliation: Wake Research Associates
name: Wayne Harper, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: MaiHealth Inc
name: Stephen Naylor, Ph.D.
role: STUDY_DIRECTOR
References: