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RecruitingNCT06388668

Lipid Testing After Myocardial Infarction at the Montreal Heart Institute

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

Status
Recruiting
Phase
Study type
Observational
Enrollment
100 (estimated)
Sponsor
Montreal Heart Institute · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTLipid panelLipid panel measuring levels of LDL, non-HDL and apoB

Timeline

Start date
2024-06-01
Primary completion
2026-03-01
Completion
2026-05-01
First posted
2024-04-29
Last updated
2025-12-03

Locations

2 sites across 1 country: Canada

Source: ClinicalTrials.gov record NCT06388668. Inclusion in this directory is not an endorsement.