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Longitudinal Study of Multi-Analyte Profile for Dyslipidemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01441908
Recruitment Status : Unknown
Verified April 2012 by MaiHealth Inc.
Recruitment status was:  Active, not recruiting
First Posted : September 28, 2011
Last Update Posted : April 16, 2012
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Dyslipidemia Drug: Pravastatin Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Determining Cardiovascular Health Using a Multi-Analyte Profile in a Longitudinal Study of a Statin Intervention for Dyslipidemia
Study Start Date : June 2011
Actual Primary Completion Date : April 2012
Estimated Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. 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 ]
    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 :
  1. Limited time-course of different stages of disease regression [ Time Frame: 6-month ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01441908

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United States, North Carolina
Wake Research Associates
Raleigh, North Carolina, United States, 27617
Sponsors and Collaborators
MaiHealth Inc
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Principal Investigator: Wayne Harper, MD Wake Research Associates
Study Director: Stephen Naylor, Ph.D. MaiHealth Inc
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Responsible Party: MaiHealth Inc Identifier: NCT01441908    
Other Study ID Numbers: MAI-001
6R44HL082382-0 ( Other Grant/Funding Number: SBIR )
6R44HL082382 ( U.S. NIH Grant/Contract )
First Posted: September 28, 2011    Key Record Dates
Last Update Posted: April 16, 2012
Last Verified: April 2012
Keywords provided by MaiHealth Inc:
Additional relevant MeSH terms:
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Lipid Metabolism Disorders
Metabolic Diseases
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors