Longitudinal Study of Multi-Analyte Profile for Dyslipidemia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by MaiHealth Inc.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
MaiHealth Inc
ClinicalTrials.gov Identifier:
NCT01441908
First received: September 21, 2011
Last updated: April 13, 2012
Last verified: April 2012
  Purpose

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 Intervention
Dyslipidemia
Drug: Pravastatin

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by MaiHealth Inc:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • Limited time-course of different stages of disease regression [ Time Frame: 6-month ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: June 2011
Estimated Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control Group
Control Group
Active Comparator: Statin
Receiving Statin
Drug: Pravastatin
40mg or 80mg dose 28 days for 6 month period

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

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01441908

Locations
United States, North Carolina
Wake Research Associates
Raleigh, North Carolina, United States, 27617
Sponsors and Collaborators
MaiHealth Inc
Investigators
Principal Investigator: Wayne Harper, MD Wake Research Associates
Study Director: Stephen Naylor, Ph.D. MaiHealth Inc
  More Information

No publications provided

Responsible Party: MaiHealth Inc
ClinicalTrials.gov Identifier: NCT01441908     History of Changes
Other Study ID Numbers: MAI-001, 6R44HL082382-0
Study First Received: September 21, 2011
Last Updated: April 13, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by MaiHealth Inc:
Cardiovascular
Multi-analyte
Statin
Dyslipidemia

Additional relevant MeSH terms:
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Pravastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 26, 2014