Overview

This trial is active, not recruiting.

Condition dyslipidemia
Treatment pravastatin
Sponsor MaiHealth Inc
Start date June 2011
End date April 2012
Trial size 40 participants
Trial identifier NCT01441908, 6R44HL082382-0, MAI-001

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification pharmacodynamics study
Intervention model parallel assignment
Masking open label
Primary purpose screening
Arm
(No Intervention)
Control Group
(Active Comparator)
Receiving Statin
pravastatin
40mg or 80mg dose 28 days for 6 month period

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).
time frame: 6-month

Secondary Outcomes

Measure
Limited time-course of different stages of disease regression
time frame: 6-month

Eligibility Criteria

Male or female participants from 30 years up to 65 years old.

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

Additional Information

Official title Determining Cardiovascular Health Using a Multi-Analyte Profile in a Longitudinal Study of a Statin Intervention for Dyslipidemia
Principal investigator Wayne Harper, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2012.
Information provided to ClinicalTrials.gov by MaiHealth Inc.