The Hellenic Postprandial Lipemia Study (HPLS) (HPLS)
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|ClinicalTrials.gov Identifier: NCT02163044|
Recruitment Status : Completed
First Posted : June 13, 2014
Last Update Posted : August 29, 2019
|Condition or disease|
|Coronary Heart Disease Dyslipidemia|
|Study Type :||Observational|
|Actual Enrollment :||580 participants|
|Official Title:||A Study to Assess the Consequences of Postprandial Lipemia in CRP as Inflammatory Marker in High-risk Adults, to Investigate Whether Hypolipidemic, Hypoglycemic or Antihypertensive Medication May Lessen the Exaggerated Postprandial Lipemia and Evaluate the Influence of Gene Polymorphisms Involved in Lipid and Glucose Metabolism on Postprandial Lipemia and Cardiovascular Outcomes.|
|Actual Study Start Date :||September 2014|
|Actual Primary Completion Date :||August 2019|
|Actual Study Completion Date :||August 2019|
Patients on statin treatment
- Change in CRP levels [ Time Frame: 0,6,12,18,24,30,36 months ]To study the consequences of postprandial lipemia in CRP as inflammatory marker in high-risk adults.
- Change in exaggerated postprandial lipemia [ Time Frame: 0,3,6,12,18,24,30,36 months ]To investigate whether hypolipidemic, hypoglycemic or antihypertensive medication may lessen the exaggerated postprandial lipemia as well as the rest abnormal postprandial metabolism.
- Change in Lipotest meal values [ Time Frame: 0,3,6,12,18,24,30,36 months ]To study the impact of postprandial lipemia using a novel test (Lipotest meal) that distinguishes very-high and high risk subjects in to two subgroups according to first Lipotest meal: the positive group with TG postprandial ≥220 mg/dl, and the negative group with TG postprandial < 220 mg/dl (Consensus criteria).
- Number of major adverse cardiovascular events [ Time Frame: 0-36 months ]To report on major adverse cardiovascular events (MACE: death from cardiovascular causes, non-fatal myocardial infarction and non-fatal stroke) in subjects in the positive and negative group.
- SCORE prediction model value measurement [ Time Frame: 0 - 36 months ]To validate a risk prediction model (SCORE) in order to compare the results from the HPLS study with the results expected to be from the SCORE prediction model.
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 ClinicalTrials.gov identifier (NCT number): NCT02163044
|Onassion Cardiology Hospital|
|Study Director:||Genovefa Kolovou, M.D., Ph.D., F.E.S.C., S.F.S.A||Onassis Cardiac Surgery of Athens|