ClinicalTrials.gg
RecruitingNCT07685639EHR-LOCALEUpdated Sep 9, 2026

Electronic Health Record Augmented LDL-Cholesterol Optimization and Control Via Active Lipid Engagement (EHR-LOCALE): A Quality Improvement Implementation Study

An interventional study of Pharmacist-led lipid optimization pathway in ACS (Acute Coronary Syndrome), Hyperlipidemia and Dyslipidemia, sponsored by University of Alberta. Recruiting at 2 sites in Canada. Per ClinicalTrials.gov, last updated 2026-09-09.

Sponsored by University of Alberta · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Started Aug 2026; still recruiting 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
2,000
Allocation
Randomized
Sex
All
01

Study 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.

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.

02

Conditions studied

  • ACS (Acute Coronary Syndrome)
  • Hyperlipidemia
  • Dyslipidemia
  • Low-Density-Lipoprotein-cholesterol Level

Keywords

  • Dyslipidemia
  • Canadian VIGOUR Centre
  • LDL
  • ACS
  • triglycerides
  • lipid
03

In context

Acute Coronary Syndrome

1,488 studies on the registry are indexed under Acute Coronary Syndrome; 273 are open to participants now.

This study's planned enrollment of 2,000 is above the median of 200 across 865 interventional studies indexed under Acute Coronary Syndrome.

Browse Acute Coronary Syndrome studies →

Lead sponsor

University of Alberta is the lead sponsor of 823 studies on the registry; 169 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Adults over the age of 18
  2. Resident of Alberta
  3. Individuals hospitalized with an acute coronary syndrome and have undergone coronary angiography.
  4. Able to participate in follow-up contact if randomized to the intervention arm

Exclusion criteria

Exclusion Criteria:

1. In-hospital mortality

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
2,000 participants (estimated)

Study arms

  • No intervention
    Usual Care

    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.

  • Active comparator
    Quality-improvement intervention

    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.

    Other: Pharmacist-led lipid optimization pathway

Interventions

  • OtherPharmacist-led lipid optimization pathway

    Referral to a centralized, pharmacist-led, telephone clinic for optimization of dyslipidemia management

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Other outcomes

  1. Cost-effectiveness of a centralized, EHR-augmented dyslipidemia management pathway following an ACS

    Time frame: From enrollment to the end of intervention at 6 months

07

Study locations

2 of 2 sites recruiting
  • University of Alberta Hospital / Mazankowski Alberta Heart Institute
    Edmonton, Alberta T6G2B7, Canada
    Recruiting
  • University of Alberta Hospital / Mazankowski Alberta Heart Institute
    Edmonton, Alberta T6G3B7, Canada
    Recruiting
08

References and documents

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 33781847 ↗
  • 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. PubMed 33289416 ↗
  • 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. PubMed 34197547 ↗
  • 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. PubMed 38582637 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2026 (actual). Primary completion is estimated for Sep 2027, 13 months after the start.

Of 210 non-industry interventional studies with no phase under Acute Coronary Syndrome, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 46. This study's planned 13 months is below that.

Counting every sponsor, half of 225 studies reached it within 34 months; a quarter within 18 and three quarters within 46.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 29, 2026
First posted
Jul 6, 2026
StartActual
Aug 10, 2026
Primary completionEst.
Sep 2027
CompletionEst.
Sep 2027
Last update
Sep 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07685639
Responsible party
Sponsor
First posted
Jul 6, 2026
Start date
Aug 10, 2026
Primary completion
Sep 2027 (estimated)
Completion
Sep 2027 (estimated)
Last update
Sep 9, 2026

Study contacts

Canadian VIGOUR Centre
Contact
ehlocale@ualberta.ca
(800) 707-9098
Pishoy Gouda, MD
principal investigator · University of Alberta

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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