Longitudinal Study of Multi-Analyte Profile for Dyslipidemia

Determining Cardiovascular Health Using a Multi-Analyte Profile in a Longitudinal Study of a Statin Intervention for Dyslipidemia

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.

Study Overview

• Status: Unknown
• Conditions: Dyslipidemia
• Intervention / Treatment: Drug: Pravastatin

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Raleigh, North Carolina, United States, 27617
      • Wake Research Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group
Active Comparator: Statin; Receiving Statin	Drug: Pravastatin; 40mg or 80mg dose 28 days for 6 month period

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	6-month

Secondary Outcome Measures

Outcome Measure	Time Frame
Limited time-course of different stages of disease regression	6-month

Collaborators and Investigators

• Sponsor: MaiHealth Inc
• Investigators: Principal Investigator: Wayne Harper, MD, Wake Research Associates; Study Director: Stephen Naylor, Ph.D., MaiHealth Inc

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): April 1, 2012
• Study Completion (Anticipated): April 1, 2012

Study Registration Dates

• First Submitted: September 21, 2011
• First Submitted That Met QC Criteria: September 26, 2011
• First Posted (Estimate): September 28, 2011

Study Record Updates

• Last Update Posted (Estimate): April 16, 2012
• Last Update Submitted That Met QC Criteria: April 13, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Keywords: Dyslipidemia; Cardiovascular; Statin; Multi-analyte
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Pravastatin
• Other Study ID Numbers: MAI-001; 6R44HL082382-0 (Other Grant/Funding Number: SBIR); 6R44HL082382 (U.S. NIH Grant/Contract)