Clinical trial NCT06388668: Lipid Testing After Myocardial Infarction at the Montreal Heart Institute
Official title: Timing of Lipid Testing During Hospitalization for MI and Subsequent Management of Dyslipidemia An Observational Study to Reduce the Care Gaps in Dyslipidemia in Canada
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Dyslipidemias
Lipid Testing
Myocardial Infarction
Lead sponsor: Montreal Heart Institute
Sponsor class: OTHER
Collaborators: name: Novartis Pharmaceuticals
First posted: 2024-04-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients hospitalized at the Cardiac Care Unit at the Montreal Heart Institute.

Brief summary: Because treatment decisions are usually based on a single measurement of the lipid panel at the time of an admission for an MI, the overarching objective of this project is to evaluate whether the measurement of LDL, non-HDL, and apoB values are reliable through all the duration of the hospitalization.

It will be a single-center, prospective, observational study will be conducted, including consecutive patients hospitalized for myocardial infarction at the Montreal Heart Institute.

Every patient at the Cardiac Care Unit will undergo non-fasting lipid panel testing at day 0 of their admission for Myocardial Infarction during the study period. Patients who consent to participate will have a 2nd non-fasting lipid panel drawn at day 2 of their admission.

Thereafter, the levels of the different lipid values from the panel will be compared between day 0, day 2, and 4-6 weeks after discharge.

Detailed description: We hypothesize that LDL, non-HDL, and apoB values are highest at time of admission and more reflective of the true patient's values, and lower near the time of discharge. Therefore, the timing of testing for the lipid panel during an admission for MI can impact the intensity with which dyslipidemia is treated (i.e. intensity of pharmacologic therapy at discharge), and followed (timing of subsequent lipid panel testing).

The objective of this project is to evaluate whether the measurement of LDL, non-HDL, and apoB values are reliable through all the duration of the hospitalization, from day 0 to day 2.

It will be a single-center, prospective, observational study will be conducted, including consecutive patients hospitalized for myocardial infarction at the Montreal Heart Institute.

Every patient at the Cardiac Care Unit will undergo non-fasting lipid panel testing at day 0 of their admission for Myocardial Infarction during the study period. Patients who consent to participate will have a 2nd non-fasting lipid panel drawn at day 2 of their admission.

The proportion of patients who undergo a repeat lipid panel, and the proportion with a LDL, non-HDL, or apoB value above the intensification threshold, at 4-6 weeks post-discharge, will be assessed. There will be no contact with participants after discharge.

A sample size of 80 to100 patients is aimed for in this exploratory study, based on feasibility and convenience. This sample size is however likely to provide enough power for the primary objective of comparing LDL levels on day 0 and day 2.

Statistical analysis will be conducted at the two-sided 0.05 significance level and performed with SAS.

LDL levels at day 0 and at day 2 will be compared using a paired Student t-test. The changes in LDL from day 0 to day 2 will be estimated and presented with a 95% confidence interval. Results will also be graphically displayed in a bar graph.

Eligibility criteria: Inclusion Criteria:

* Adult patients ≥18 years old
* Hospitalized at the Cardiac Care Unit for Myocardial Infarction (either NSTEMI or STEMI)
* Lipid panel performed on day 0 of admission
* Willing to provide informed consent

Exclusion Criteria:

* None

Primary outcomes:
measure: Variation in LDL
timeFrame: Day 0 to day 2
Secondary outcomes:
measure: Variation in non-HDL and apoB
timeFrame: Day 0 to day 2
measure: Evaluation of intensification threshold
timeFrame: Day 0 to day 2
Other outcomes:
measure: Repeat lipid panel after discharge
timeFrame: 4-6 weeks
measure: Evaluation of intensification threshold after discharge
timeFrame: 4-6 weeks
Locations:
city: Montreal
country: Canada
facility: Montreal Heart Institute
state: Quebec
city: Montréal
country: Canada
facility: Montreal Heart Institute
state: Quebec
Study officials:
affiliation: Montreal Heart Institute
name: Guillaume Marquis-Gravel, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
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