DyslipidemiaNCT01441908
Longitudinal Study of Multi-Analyte Profile for Dyslipidemia
A study testing Pravastatin in people with Dyslipidemia, run by MaiHealth Inc at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Dyslipidemia
- What is being tested?
- Pravastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Apr 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Research Associates
Raleigh, North Carolina, 27617
About this study
Official title: 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.
Read the 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.
- Conditions
- Dyslipidemia
- Being tested
- Pravastatin
- Keywords
- Cardiovascular, Multi-analyte, Statin, Dyslipidemia
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PravastatinDrug
40mg or 80mg dose 28 days for 6 month period
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Control Group |
| Statin | Active comparator | Receiving Statin Receives: Drug: Pravastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6-month
Secondary outcomes (1)
Limited time-course of different stages of disease regression
Measured: 6-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2011 (estimated)
- Study startJun 2011
- Primary completionApr 2012
- Study completionApr 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MaiHealth Inc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wayne Harper, MD, Principal investigator, Wake Research AssociatesStephen Naylor, Ph.D., Study director, MaiHealth Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01441908
- Sponsor's protocol ID
- MAI-001
- Other IDs
- 6R44HL082382-0, 6R44HL082382
- Status last verified
- Apr 2012
- First submitted
- 21 Sep 2011
- Last updated
- 16 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining Cardiovascular Health Using a Multi-Analyte Profile in a Longitudinal Study of a Statin Intervention for Dyslipidemia
- ClinicalTrials.gov ID
- NCT01441908
- Acronym / sponsor ID
- MAI-001
- Conditions
- Dyslipidemia
- Keywords
- Cardiovascular, Multi-analyte, Statin, Dyslipidemia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- MaiHealth IncUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (estimated)
- First posted
- 28 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Control Group |
| Statin | Active comparator | Drug: PravastatinReceiving Statin |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pravastatin40mg or 80mg dose 28 days for 6 month period | Drug | Statin |
Primary outcome
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.
1 secondary outcome
Limited time-course of different stages of disease regression
Time frame: 6-month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wayne Harper, MD principal investigator
Wake Research Associates
Stephen Naylor, Ph.D. study director
MaiHealth Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pravastatin in people with Dyslipidemia, run by MaiHealth Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2012.