Dyslipidemia
Conditions
Brief summary
Cross-sectional observational study designed to identify and describe the care gap in guideline-oriented low density lipoprotein cholesterol (LDL-C) management in Canadian patients at high cardiovascular risk.
Detailed description
This is a cross-sectional observational study designed to provide real-life data on the current management of dyslipidemia in high cardiovascular risk patients in routine clinical practice. Canadian guidelines recommend a target for LDL-C of ≤2.0 mmol/L (or ≥50% decrease) after treatment initiation in high-risk patients. The recommended first line treatment is statin therapy. Available data clearly indicates that up to 50% of high risk patients do not achieve this important target because of statin inadequacy or intolerance leading to non-adherence. Therefore this program aims to provide further insights into the challenges Canadian physicians face in helping their high risk patients achieve guideline-recommended LDL-C.
Interventions
OTHERsurvey
This is a cross-sectional study without specific intervention
Sponsors
Amgen
Canadian Heart Research Centre
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1\. Adults ≥ 18 years old 2. High risk for cardiovascular morbidity and mortality (at least one of the following): 1. Clinical vascular disease: * Coronary Artery Disease (CAD): history of myocardial infarction (MI), Coronary artery bypass grafting (CABG), percutaneous coronary intervention (PCI), angiographic disease * Cerebrovascular Disease (CeVD): history of cerebrovascular accident (CVA) or transient ischemic attack (TIA), carotid surgery * Abdominal Aortic Aneurism (AAA): history of surgery/intervention * Peripheral Arterial Disease (PAD): history of surgery/intervention 2. Familial hypercholesterolemia defined as LDL-C \> 5 mmol/L and one of: * typical physical findings (stigmata) such as tendon xanthomata, xanthelasma, and arcus corneae * personal history of early cardiovascular disease * family history of early cardiovascular disease or of marked hyperlipidemia 3. Receiving current optimal (maximal or maximal tolerated) statin therapy for at least 3 months prior to patient enrolment 4. LDL-C \> 2.0 mmol/L measured within 6 months of patient enrolment date and while on (despite) maximal tolerated statin therapy (± other lipid modifying therapies). 5. Desire and ability to execute the consent to participate.
Exclusion criteria
1. Current treatment with PCSK9 inhibitor 2. Participation in an investigational study 3. Prior participation in the GOAL program
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean LDL-C level according to lipid lowering treatment received | up to 2 years | defined as: a. Prior cardiovascular disease, b. High risk Diabetes (as per Canadian Diabetes Association Guidelines), c. High risk patients based on Framingham score; and according to LDL-C between 2.5 and 3.0 mmol/L and LDL \> 3.0 mmol/L |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean LDL-C level in patients with Familial Hypercholesterolemia | up to 2 years | — |
| Mean LDL-C level in patients with statin intolerance | up to 2 years | — |
| Mean LDL-C level in patients receiving combination dyslipidemia therapy | up to 2 years | — |
| Mean LDL-C level according to statin efficacy | up to 2 years | according to patient's statin efficacy (high, moderate, etc. by dose) |
| Mean LDL-C level according to their type of medication insurance coverage | up to 2 years | — |
Outcome results
None listed