Effectiveness of a Shared Decision Aid Tool for Cardiovascular Risk Prevention in Hypercholesterolemic...
HypercholesterolemiaCardiovascular RiskBACKGROUND: Mediterraneans have traditionally a low cardiovascular risk, although emerging lifestyles might change the trend. The aim of this study is to assess if hypercholesterolemic patient involvement in the preventive decision with the help of a decision aid has an impact on cardiovascular (CV) risk reduction superior to usual care. METHOD: The design is a cluster randomised clinical trial. Participants are hypercholesterolemic patients (>200 mg/dl or c-LDL>130) from four primary care teams of Barcelona. Patients with previous CV events, age over 75 years or cognitive impairment are excluded. It is expected to create two cohorts of 139 patients each one. The randomisation is by doctor. Intervention group will receive information about their CV risk and the risk and benefits of different preventive measures. They will have access to a decission aid that will help them in the choice of the preventive measures.The material (printed and software) is adapted to the Catalan Population using local CV risk tables and will meet the CREDIBLE and DISCERN criteria. STUDY VARIABLES: Sociodemographic variables, CV risk factors, subjective health (SF 12), decisional conflict, anxiety/depression, analytic controls, treatment, treatment adherence, compliance and resources use. Basal evaluation and 3, 6, 12 month assessment. The study, financed by FIS, will begin the 01-07-2007. RESULTS: The expected results are a higher reduction on the CV risk factors in the intervention group versus regular care. CONCLUSIONS Study will provide a tool to be used in Spanish and Catalan population.
Use of Decision Aids in Clinical Encounters
DiabetesDepression2 moreThe active strategy for dissemination and implementation of Share Evidence Based Medicine (EBM) will yield greater reach of clinicians, be adopted by the practices more readily, and a greater uptake of use amongst encounters will be seen. The Institute for Clinical Systems Improvement (ICSI) is a nonprofit organization with expertise in large-scale practice improvement at the state and national level. Largely funded by health organizations in Minnesota, ICSI has a sustainable model to translate evidence into practice, through clinical practice guidelines, shared decision making, and practice redesign. A partnership between these two organizations (ICSI and Mayo Clinic) may lead to a sustainable and innovative approach to the dissemination of evidence-based health information at the point of care. The objective of the current study is therefore to leverage the expertise of these two organizations to compare the impact of an active to a passive dissemination and implementation strategy of the ShareEBM toolkit. The aim of the study is to disseminate evidence-based information through the use of decision aids during encounters. The overall purpose of the qualitative evaluation is to understand why decision aids were used more or less in certain practices and what factors contributed to or hindered this uptake.
Relationships Between Plasma PCSK9 Levels, LDL-cholesterol Concentrations and Lipoprotein (a) Levels...
Familial HypercholesterolemiaFamilial hypercholesterolemia (FH) is an autosomal codominant single gene disorder caused by mutations in the LDL receptor gene (LDLR) that disrupt the normal clearance of LDL particles from the plasma. Heterozygous patients (HeFH) present a two- to three-fold raise in plasma LDL-cholesterol (LDL-C) concentrations and coronary artery disease occurs earlier among HeFH carrying negative-receptor (NR) mutations as compared with HeFH subjects carrying defective-receptor (DR) variants. Proprotein convertase subtilisin/kexin type 9 (PCSK9) regulates LDL-C levels by binding to LDLR and by enhancing its intracellular degradation. The objective of this study is to examine to what extent variations in LDL-C and Lipoprotein (Lp) (a) concentrations are related to PCSK9 levels in a large French-Canadian cohort of HeFH subjects. The primary hypothesis is that that PCSK9 levels have a significant impact on LDL-C concentration variability and are associated with Lp(a) levels.
Gene Analysis and Treatment Optimization in Chinese Homozygous Familial Hypercholesterolemia
Homozygous Familial HypercholesterolemiaIdentify new or novel genes which may impact on cholesterol level, and establish the relationship between those gene mutations with atherosclerosis, as well as responses to lipid-lowering drugs.
Vytorin Reexamination Study (0653A-174)
Primary Hypercholesterolemia and Homozygous Familial Hypercholesterolemia (HoFH)This survey is conducted for preparing application material for re-examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the clinical usefulness of VYTORIN through collecting the safety and efficacy information according to the Re-examination Regulation for New Drugs.
Bioequivalence Study On Pediatric Appropriate Formulation
HypercholesterolemiaTo determine bioequivalence of a atorvastatin pediatric formulation comparing to the 10 mg commercial atorvastatin calcium tablet formulation.
Evaluation of the Safety, Tolerability and Efficacy of Ezetimibe on a Select Population of Filipinos...
Primary HypercholesterolemiaHomozygous Familial HypercholesterolemiaThe purpose of this study is to evaluate the overall safety, tolerability, and efficacy of Ezetimibe when used alone or in combination with a statin in patients with hypercholesterolemia
A 52-week Post-marketing, Observational Study to Confirm the Safety and Efficacy of Zetia Alone...
HypercholesterolemiaFamilial Hypercholesterolemia1 moreThis study is a non-interventional (observational) study in Japan to confirm the safety and efficacy of Zetia when administered alone or in combination with other lipid-lowering drugs in daily medical practice throughout a 52-week period. It is being conducted as a post-approval commitment, in accordance with the Ministry of Health, Labour and Welfare's guideline on Good Post-marketing Study Practice. Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.
Sex Hormones and Blood PCSK9 Levels
HypercholesterolemiaThis study measures a recently discovered protein named PCSK9 (Proprotein convertase subtilisin kexin 9) in blood to see if it is influenced by male and female sex hormones. PCSK9 has recently been shown to control cholesterol and triglyceride levels by diminishing the ability of liver cells to remove cholesterol from blood leading to high blood cholesterol levels. It was found in previous studies that there was a relationship between blood levels of PCSK9 and cholesterol in men but not in women. This gender difference is a new finding and it raises the question of whether male and female hormones might influence PCSK9's role as a blood cholesterol regulator. The study requires a pre-treatment fasting blood sample and another sample 3 months after starting hormone therapy.
Differential Metabolic Effects of Statins
HypercholesterolemiaThe investigators hypothesized simvastatin and pravastatin may have differential metabolic effects in hypercholesterolemic patients.