ACS (Acute Coronary Syndrome)EHR-LOCALENCT07685639
Electronic Health Record Augmented LDL-Cholesterol Optimization and Control Via Active Lipid Engagement (EHR-LOCALE): A Quality Improvement Implementation Study
A study testing Pharmacist-led lipid optimization pathway in people with ACS (Acute Coronary Syndrome) and Hyperlipidemia, run by University of Alberta at 2 sites in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- ACS (Acute Coronary Syndrome), Hyperlipidemia, Dyslipidemia
- What is being tested?
- Pharmacist-led lipid optimization pathway
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 2 sitesCanada
- Study dates
- 10 Aug 2026to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adults over the age of 18
- Resident of Alberta
- Individuals hospitalized with an acute coronary syndrome and have undergone coronary angiography.
- Able to participate in follow-up contact if randomized to the intervention arm
Who cannot join
- 1. In-hospital mortality
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Recruiting
University of Alberta Hospital / Mazankowski Alberta Heart Institute
Edmonton, Alberta, T6G2B7
Pishoy Gouda, MD, 17804072098, gouda@ualberta.ca
- Recruiting
University of Alberta Hospital / Mazankowski Alberta Heart Institute
Edmonton, Alberta, T6G3B7
About this study
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:
- Pharmacist contact
- Repeat lipid requisitions
- Review of medications, adherence, and side effects
- Treatment escalation according to national dyslipidemia guidelines
Read the detailed description
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.
- Conditions
- ACS (Acute Coronary Syndrome), Hyperlipidemia, Dyslipidemia, Low-Density-Lipoprotein-cholesterol Level
- Being tested
- Pharmacist-led lipid optimization pathway
- Keywords
- Dyslipidemia, Canadian VIGOUR Centre, LDL, ACS, triglycerides, lipid
- Medical subject headings
- Acute Coronary Syndrome, Hyperlipidemias, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacist-led lipid optimization pathwayOther
Referral to a centralized, pharmacist-led, telephone clinic for optimization of dyslipidemia management
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Pharmacist-led lipid optimization pathway |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of individuals who achieve guideline recommended low-density-lipoprotein (LDL) cholesterol target of <1.8 mmol/L at 6-months
Measured: From enrollment to the end of intervention at 6 months
Secondary outcomes (4)
Proportion of individuals with repeat lipid panel testing at 3-months and 6-months
Measured: From enrollment to the end of intervention at 6 months
Proportion of individuals who undergo escalation or addition of new of lipid lowering therapies
Measured: From enrollment to the end of intervention at 6 months
Absolute difference in lipid values (LDL-C, high-density lipoprotein-cholesterol [HDL-C], non-HDL cholesterol, triglycerides) at six-months
Measured: 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
Measured: From enrollment to 1 year and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start10 Aug 2026
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ACS (Acute Coronary Syndrome)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pishoy Gouda, MD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07685639
- Sponsor's protocol ID
- Pro00161129
- Other IDs
- Canadian VIGOUR Centre
- Acronym
- EHR-LOCALE
- Status last verified
- Sep 2026
- First submitted
- 29 Jun 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 33781847Claessen 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.
PubMed 33289416Gouda 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.
PubMed 34197547Welsh 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.
PubMed 38582637
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electronic Health Record Augmented LDL-Cholesterol Optimization and Control Via Active Lipid Engagement (EHR-LOCALE): A Quality Improvement Implementation Study
- ClinicalTrials.gov ID
- NCT07685639
- Acronym / sponsor ID
- EHR-LOCALE / Pro00161129
- Conditions
- ACS (Acute Coronary Syndrome), Hyperlipidemia, Dyslipidemia, Low-Density-Lipoprotein-cholesterol Level
- Keywords
- Dyslipidemia, Canadian VIGOUR Centre, LDL, ACS, triglycerides, lipid
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 10 Aug 2026 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 6 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Pharmacist contact
- Repeat lipid requisitions
- Review of medications, adherence, and side effects
- Treatment escalation according to national dyslipidemia guidelines
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Pharmacist-led lipid optimization pathwayParticipants 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Adults over the age of 18
- Resident of Alberta
- Individuals hospitalized with an acute coronary syndrome and have undergone coronary angiography.
- Able to participate in follow-up contact if randomized to the intervention arm
Key exclusion criteria (1 listed)
- 1. In-hospital mortality
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmacist-led lipid optimization pathwayReferral to a centralized, pharmacist-led, telephone clinic for optimization of dyslipidemia management | Other | Quality-improvement intervention |
Primary outcome
Proportion of individuals who achieve guideline recommended low-density-lipoprotein (LDL) cholesterol target of <1.8 mmol/L at 6-months
Time frame: From enrollment to the end of intervention at 6 months
4 secondary outcomes
Proportion of individuals with repeat lipid panel testing at 3-months and 6-months
Time frame: From enrollment to the end of intervention at 6 months
Proportion of individuals who undergo escalation or addition of new of lipid lowering therapies
Time frame: From enrollment to the end of intervention at 6 months
Absolute difference in lipid values (LDL-C, high-density lipoprotein-cholesterol [HDL-C], non-HDL cholesterol, triglycerides) at six-months
Time frame: 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
Time frame: From enrollment to 1 year and 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Background: PubMed 33781847Pearson 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.
- Background: PubMed 33289416Claessen 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.
- Background: PubMed 34197547Gouda 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.
- Background: PubMed 38582637Welsh 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.
- Individual participant dataSharing planned: Undecided
Related trials for ACS (Acute Coronary Syndrome)
Not yet recruitingObservational study
Prognostic Value of Functional-Nutritional Status in Older Adults With Acute Coronary Syndrome
Acute Coronary Syndromes (ACS)
Active, not recruiting
Interventional Strategy for Non-culprit Lesions With Major Vulnerability Criteria at OCT in Patients With ACS
Coronary Artery Disease, Coronary Disease
Not yet recruitingObservational study
AI-ECG Detection of Occlusion Myocardial Infarction at Emergency Department Triage (TRIACS)
Acute Coronary Syndromes, Chest Pain
Recruiting
Fexuprazan for Prevention of Upper Gastrointestinal Bleeding in High Bleeding Risk Patients Receiving Dual Antiplatelet Therapy
Acute Coronary Syndromes (ACS), Coronary Artery Disease (CAD)
RecruitingPhase 4
Effectiveness of Interventional Therapy for Non-Flow-Limiting Vulnerable Plaques
Coronary Arterial Disease (CAD), Vulnerable Coronary Plaques
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pishoy Gouda, MD principal investigator
University of Alberta
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacist-led lipid optimization pathway in people with ACS (Acute Coronary Syndrome) and Hyperlipidemia, run by University of Alberta at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Canadian VIGOUR Centre ((800) 707-9098, ehlocale@ualberta.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of individuals who achieve guideline recommended low-density-lipoprotein (LDL) cholesterol target of <1.8 mmol/L at 6-months (time frame: From enrollment to the end of intervention at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07685639, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.