Longitudinal Study of Multi-Analyte Profile for Dyslipidemia

MaiHealth Inc

Status

Unknown

Conditions

Dyslipidemia

Treatments

Drug: Pravastatin

Study type

Interventional

Funder types

Other

Identifiers

NCT01441908

6R44HL082382-0 (Other Grant/Funding Number)

MAI-001

6R44HL082382 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

30 to 65 years old

Volunteers

No Healthy Volunteers

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