Ignite Creation Date:
2025-12-24 @ 10:32 PM
Ignite Modification Date:
2026-02-25 @ 8:11 PM
Study NCT ID:
NCT02537535
Status:
COMPLETED
Last Update Posted:
2020-01-23
First Post:
2015-08-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Guidelines Oriented Approach to Lipid Lowering (GOAL) in Canada
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050171', 'term': 'Dyslipidemias'}], 'ancestors': [{'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2027}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-22', 'studyFirstSubmitDate': '2015-08-26', 'studyFirstSubmitQcDate': '2015-08-28', 'lastUpdatePostDateStruct': {'date': '2020-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean LDL-C level according to lipid lowering treatment received', 'timeFrame': 'up to 2 years', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Mean LDL-C level in patients with Familial Hypercholesterolemia', 'timeFrame': 'up to 2 years'}, {'measure': 'Mean LDL-C level in patients with statin intolerance', 'timeFrame': 'up to 2 years'}, {'measure': 'Mean LDL-C level in patients receiving combination dyslipidemia therapy', 'timeFrame': 'up to 2 years'}, {'measure': 'Mean LDL-C level according to statin efficacy', 'timeFrame': 'up to 2 years', 'description': "according to patient's statin efficacy (high, moderate, etc. by dose)"}, {'measure': 'Mean LDL-C level according to their type of medication insurance coverage', 'timeFrame': 'up to 2 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dyslipidemia']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nTherefore this program aims to provide further insights into the challenges Canadian physicians face in helping their high risk patients achieve guideline-recommended LDL-C.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Low density lipoprotein cholesterol (LDL-C) management in Canadian patients at high cardiovascular risk', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\. Adults ≥ 18 years old 2. High risk for cardiovascular morbidity and mortality (at least one of the following):\n\n1. Clinical vascular disease:\n\n * Coronary Artery Disease (CAD): history of myocardial infarction (MI), Coronary artery bypass grafting (CABG), percutaneous coronary intervention (PCI), angiographic disease\n * Cerebrovascular Disease (CeVD): history of cerebrovascular accident (CVA) or transient ischemic attack (TIA), carotid surgery\n * Abdominal Aortic Aneurism (AAA): history of surgery/intervention\n * Peripheral Arterial Disease (PAD): history of surgery/intervention\n2. Familial hypercholesterolemia defined as LDL-C \\> 5 mmol/L and one of:\n\n * typical physical findings (stigmata) such as tendon xanthomata, xanthelasma, and arcus corneae\n * personal history of early cardiovascular disease\n * family history of early cardiovascular disease or of marked hyperlipidemia\n3. Receiving current optimal (maximal or maximal tolerated) statin therapy for at least 3 months prior to patient enrolment\n4. 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).\n5. Desire and ability to execute the consent to participate.\n\nExclusion criteria:\n\n1. Current treatment with PCSK9 inhibitor\n2. Participation in an investigational study\n3. Prior participation in the GOAL program'}, 'identificationModule': {'nctId': 'NCT02537535', 'acronym': 'GOAL', 'briefTitle': 'Guidelines Oriented Approach to Lipid Lowering (GOAL) in Canada', 'organization': {'class': 'OTHER', 'fullName': 'Canadian Heart Research Centre'}, 'officialTitle': 'Guidelines Oriented Approach to Lipid Lowering (GOAL) in Canada', 'orgStudyIdInfo': {'id': 'CHRC2014-GOAL Canada Study'}}, 'armsInterventionsModule': {'interventions': [{'name': 'survey', 'type': 'OTHER', 'description': 'This is a cross-sectional study without specific intervention'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Canadian Heart Research Centre', 'class': 'OTHER'}, 'collaborators': [{'name': 'Amgen', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Anatoly Langer, MD, M.Sc., FRCP (C), FACC -Chair, Canadian Heart Research Centre', 'investigatorFullName': 'Dr. Anatoly Langer', 'investigatorAffiliation': 'Canadian Heart Research Centre'}}}}