Dyslipidemia Clinical Trial
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.
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.
;
Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00001154 -
Lipoprotein Metabolism in Normal Volunteers and Patients With High Levels of Lipoproteins
|
||
| Not yet recruiting |
NCT06405880 -
Pharmacist Case Finding and Intervention for Vascular Prevention Trial
|
N/A | |
| Recruiting |
NCT02837367 -
Use of Nutrigenomic Models for the Personalized Treatment With Medical Foods in Obese People
|
N/A | |
| Active, not recruiting |
NCT02600338 -
Meta-analyses of the Effect of Legumes on Blood Pressure
|
N/A | |
| Active, not recruiting |
NCT02223793 -
Vascular Lifestyle-Intervention and Screening in Pharmacy
|
N/A | |
| Completed |
NCT02163044 -
The Hellenic Postprandial Lipemia Study (HPLS)
|
||
| Recruiting |
NCT01972113 -
Vitamin K and Glucose Metabolism in Children at Risk for Diabetes (Vita-K 'n' Kids Study)
|
N/A | |
| Recruiting |
NCT01705873 -
Analysis on the Risk of Cardiovascular Events in HIV- Infected Subjects Treated With LPV/r Based HAART Regimen vs. an EFV Based Regimen
|
N/A | |
| Completed |
NCT01764295 -
Clinical Study for Patients With Hypertension Associated With Dyslipidemia
|
Phase 3 | |
| Completed |
NCT01531062 -
Effect of Nigella Sativa on Lipid Profiles in Elderly
|
Phase 2 | |
| Completed |
NCT01990391 -
Brazil Nut Consumption in Microvascular Endothelial Function, Oxidative Stress and Metabolic Abnormalities
|
N/A | |
| Terminated |
NCT01414166 -
Niacin/Laropiprant Tablet for South and Southeast Asians With Low High-Density Lipoprotein Cholesterol (LDL-C) at Risk for Cardiovascular Disease (MK-0524A-108)
|
Phase 3 | |
| Recruiting |
NCT01670968 -
HIV Reverse Cholesterol Transport Study
|
||
| Completed |
NCT00977288 -
A Study of Safety and Efficacy of MK0859 (Anacetrapib) in Japanese Patients With Dyslipidemia (0859-029)
|
Phase 2 | |
| Completed |
NCT00768274 -
Safety, Pharmacokinetic Study of RVX000222 in Healthy Subjects and Subjects With Low HDL Cholesterol
|
Phase 1/Phase 2 | |
| Completed |
NCT01285544 -
The Efficacy and Tolerability of Two Formulations of Atorvastatin In Korean Adult With Hypercholesterolemia
|
Phase 4 | |
| Withdrawn |
NCT00664287 -
Extended Release (ER) Niacin/Laropiprant Add on Study (0524A-082)
|
Phase 3 | |
| Completed |
NCT00300430 -
Study to Evaluate the Long-Term Safety and Efficacy of ABT-335, in Combination With Three Different Statins in Subjects With Mixed Dyslipidemia.
|
Phase 3 | |
| Completed |
NCT01483235 -
Reduced Cardiac Rehabilitation Program
|
N/A | |
| Terminated |
NCT00816829 -
Effect of Fenofibrate on Sleep Apnea Syndrome
|
Phase 2 |