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| ID | Type | Description | Link |
|---|---|---|---|
| Canadian VIGOUR Centre | Other Identifier | University of Alberta |
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The purpose of this study is to determine whether a proactive, EHR-guided approach helps more individuals reach safe cholesterol levels, improves medication use, and reduces future heart attacks and strokes, compared to usual care.
The main question it aims to answer is:
• Does the EHR-LOCALE pathway increases the proportion of patients who reach the LDL-cholesterol target of <1.8 mmol/L at 6 months?
Participants in the interventional group receive:
After a heart event, such as a heart attack, many people never reach the cholesterol levels needed to lower their risk of experiencing another heart event even with good care. This research study is evaluating a new way to better support patients in reaching those targets. The EHR-LOCALE study uses Alberta's electronic health record (EHR) to automatically identify these individuals and offer them extra support. Those who are not at their cholesterol target are contacted by a pharmacist, who can order blood tests, review medications, and adjust treatment according to national guidelines.
This project tests whether this proactive, EHR-guided approach helps more patients reach safe cholesterol levels, improves medication use, and reduces future heart attacks and strokes, compared to usual care. Ultimately, it aims to make cholesterol management after a heart event more consistent, equitable, and effective.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | No Intervention | Participants in the usual care arm will have data collected (baseline demographics, medical history, laboratory values, medication usage and clinical outcomes) from their health record. Usual care will include follow-up with their primary cardiologist, primary care physician, cardiac rehabilitation team and community pharmacy as per standards of care across Canada and the CCS Dyslipidemia Guidelines. This data will include information regarding their cholesterol levels and cholesterol treatments received as per standard of care practices. | |
| Quality-improvement intervention | Active Comparator | Participants in the intervention will provide verbal consent to participate. In addition to data collection, Pharmacist contact will occur monthly until their cholesterol levels at target or if they no longer wish to participate in the study, no further changes in medications will occur and no further follow-up is required. Participation in the interventional arm can last up to 6 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pharmacist-led lipid optimization pathway | Other | Referral to a centralized, pharmacist-led, telephone clinic for optimization of dyslipidemia management |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of individuals who achieve guideline recommended low-density-lipoprotein (LDL) cholesterol target of <1.8 mmol/L at 6-months | From enrollment to the end of intervention at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of individuals with repeat lipid panel testing at 3-months and 6-months | From enrollment to the end of intervention at 6 months | |
| Proportion of individuals who undergo escalation or addition of new of lipid lowering therapies | From enrollment to the end of intervention at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Cost-effectiveness of a centralized, EHR-augmented dyslipidemia management pathway following an ACS | From enrollment to the end of intervention at 6 months |
Inclusion Criteria:
Exclusion Criteria:
1. In-hospital mortality
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Canadian VIGOUR Centre | Contact | (800) 707-9098 | ehlocale@ualberta.ca |
| Name | Affiliation | Role |
|---|---|---|
| Pishoy Gouda, MD | University of Alberta | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33781847 | Background | Pearson GJ, Thanassoulis G, Anderson TJ, Barry AR, Couture P, Dayan N, Francis GA, Genest J, Gregoire J, Grover SA, Gupta M, Hegele RA, Lau D, Leiter LA, Leung AA, Lonn E, Mancini GBJ, Manjoo P, McPherson R, Ngui D, Piche ME, Poirier P, Sievenpiper J, Stone J, Ward R, Wray W. 2021 Canadian Cardiovascular Society Guidelines for the Management of Dyslipidemia for the Prevention of Cardiovascular Disease in Adults. Can J Cardiol. 2021 Aug;37(8):1129-1150. doi: 10.1016/j.cjca.2021.03.016. Epub 2021 Mar 26. | |
| 33289416 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 22, 2026 |
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| Absolute difference in lipid values (LDL-C, high-density lipoprotein-cholesterol [HDL-C], non-HDL cholesterol, triglycerides) at six-months | From enrollment to the end of intervention at 6 months |
| Composite of all-cause mortality, hospitalization for myocardial infarction, hospitalization for stroke and unplanned coronary revascularization at one-year and five-years | From enrollment to 1 year and 5 years |
| Background |
| Claessen BE, Guedeney P, Gibson CM, Angiolillo DJ, Cao D, Lepor N, Mehran R. Lipid Management in Patients Presenting With Acute Coronary Syndromes: A Review. J Am Heart Assoc. 2020 Dec 15;9(24):e018897. doi: 10.1161/JAHA.120.018897. Epub 2020 Dec 8. |
| 34197547 | Background | Gouda P, Savu A, Bainey KR, Kaul P, Welsh RC. Long-term risk of death and recurrent cardiovascular events following acute coronary syndromes. PLoS One. 2021 Jul 1;16(7):e0254008. doi: 10.1371/journal.pone.0254008. eCollection 2021. |
| 38582637 | Background | Welsh RC, Gouda P, Dover D, Bainey KR, McAlister FA, Kaul P. Applicability and impact of the COMPASS trial in a Canadian population of patients with atherosclerotic disease. Atherosclerosis. 2024 Jun;393:117486. doi: 10.1016/j.atherosclerosis.2024.117486. Epub 2024 Mar 16. |
| Jun 23, 2026 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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