Guidelines Oriented Approach to Lipid Lowering (GOAL) in Canada

NCT02537535 | Completed

• 1 other identifier: CHRC2014-GOAL Canada Study
• Study Type: observational
• Target: 2,027
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dyslipidemia

Outcome Measures

Primary Outcomes (1)

• Mean LDL-C level according to lipid lowering treatment received

  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

  up to 2 years

Secondary Outcomes (5)

• 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

• Mean LDL-C level according to their type of medication insurance coverage

  up to 2 years

Interventions

survey OTHER

This is a cross-sectional study without specific intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Low density lipoprotein cholesterol (LDL-C) management in Canadian patients at high cardiovascular risk

You may qualify if:

• \. Adults ≥ 18 years old 2. High risk for cardiovascular morbidity and mortality (at least one of the following):
• 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
• 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
• Receiving current optimal (maximal or maximal tolerated) statin therapy for at least 3 months prior to patient enrolment
• 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).
• Desire and ability to execute the consent to participate.

You may not qualify if:

• Current treatment with PCSK9 inhibitor
• Participation in an investigational study
• Prior participation in the GOAL program

Sponsors & Collaborators

• Canadian Heart Research Centre: lead
• Amgen: collaborator

MeSH Terms

Conditions

Dyslipidemias

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anatoly Langer, MD, M.Sc., FRCP (C), FACC -Chair, Canadian Heart Research Centre

Study Record Dates

• First Submitted: August 26, 2015
• First Posted: September 1, 2015
• Study Start: January 1, 2016
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: January 23, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share