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
3 other identifiers
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2011
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 21, 2011
CompletedFirst Posted
Study publicly available on registry
September 28, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedApril 16, 2012
April 1, 2012
10 months
September 21, 2011
April 13, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (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).
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 Outcomes (1)
Limited time-course of different stages of disease regression
6-month
Study Arms (2)
Control Group
NO INTERVENTIONControl Group
Statin
ACTIVE COMPARATORReceiving Statin
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MaiHealth Inclead
Study Sites (1)
Wake Research Associates
Raleigh, North Carolina, 27617, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wayne Harper, MD
Wake Research Associates
- STUDY DIRECTOR
Stephen Naylor, Ph.D.
MaiHealth Inc
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 21, 2011
First Posted
September 28, 2011
Study Start
June 1, 2011
Primary Completion
April 1, 2012
Study Completion
April 1, 2012
Last Updated
April 16, 2012
Record last verified: 2012-04