Validation of Treating to Non-Fasting Lipid Targets in Comparison to Fasting Lipid Targets

Conditions: hyperlipidemiahypercholesterolemiasecondary cardiovascular preventionFastingnon-fasting

Registration Number: NL-OMON26747

Lead Sponsor: Albert Schweitzer Ziekenhuis

Brief Summary: 1. Bansal, S., Buring, J. E., Rifai, N., Mora, S., Sacks, F. M., and Ridker, P. M. (2007) Fasting compared with nonfasting triglycerides and risk of cardiovascular events in women. JAMA.298, 309-316 3. Eberly, L. E., Stamler, J., and Neaton, J. D. (2003) Relation of triglyceride levels, fasting and nonfasting, to fatal and nonfatal coronary heart disease. Arch Intern Med.163, 1077-1083 4. Mora, S., Rifai, N., Buring, J. E., and Ridker, P. M. (2008) Fasting compared with nonfasting lipids and apolipoproteins for predicting incident cardiovascular events. Circulation.118, 993-1001 5. Nordestgaard, B. G., Benn, M., Schnohr, P., and Tybjaerg-Hansen, A. (2007) Nonfasting triglycerides and risk of myocardial infarction, ischemic heart disease, and death in men and women. JAMA.298, 299-308 6. Langsted, A., and Nordestgaard, B. G. (2011) Nonfasting Lipids, Lipoproteins, and Apolipoproteins in Individuals with and without Diabetes: 58 434 Individuals from the Copenhagen General Population Study. Clin Chem.57, 482-489 7. Klop, B., Cohn, J. S., van Oostrom, A. J., van Wijk, J. P., Birnie, E., and Castro Cabezas, M. (2011) Daytime triglyceride variability in men and women with different levels of triglyceridemia. Clin Chim Acta.412, 2183-2189 8. Sidhu, D., and Naugler, C. (2012) Fasting time and lipid levels in a community-based population: a cross-sectional study. Arch Intern Med.172, 1707-1710 9. de Vries, M., Klop, B., and Castro Cabezas, M. (2014) The use of the non-fasting lipid profile for lipid-lowering therapy in clinical practice - point of view. Atherosclerosis.234, 473-475 10. Khera, A. V., and Mora, S. (2012) Fasting for lipid testing: is it worth the trouble?: comment on "fasting time and lipid levels in a community-based population". Arch Intern Med.172, 1710-1711

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 350

Inclusion Criteria

Male and female patients, aged 18 years or older, from the outpatient department of Cardiology and Internal Medicine receiving lipid lowering therapy as secondary cardiovascular prevention are suitable for inclusion. Lipid lowering therapy is defined as the use of statins, fibrates, ezetimibe or nicotinic acid or a combination of these

Exclusion Criteria

A change in lipid lowering therapy within the last 4 weeks is an exclusion criterium for study participation.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The number of patients that reach the set treatment target of LDL-C <2.5 mmol/l when using non-fasting blood samples while their fasting LDL is>2.5mmol/l.

Secondary Outcome Measures

Name	Time	Method
-The number of patients that reach the set treatment target of apo B <0.8 g/l when using non-fasting blood samples and do not reach the target in fasting blood samples.<br /><br>-The number of patients who reach the set treatment target of non-HDL-C<3.3mmol/l when using non-fasting blood samples and do not reach the target in fasting blood samples.<br /><br>-Differences in morning and afternoon LDL-C levels.<br /><br>-Absolute differences in fasting and non-fasting LDL-C, direct LDL-C, apo B, non-HDL-C and triglycerides.<br />-Absolute differences between calculated LDL-C, direct LDL-C and LDL-C using ultracentrifuge in relation to the triglyceride concentrations.<br /><br>-Construction of ROC curves to determine optimal normal values for non-fasting LDL-C.<br>