Lipid Testing After Myocardial Infarction at the Montreal Heart Institute

April 24, 2024 updated by: 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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Quebec
      • Montréal, Quebec, Canada, H1T 1C8
        • Montreal Heart Institute
        • Contact:
        • Principal Investigator:
          • Guillaume Marquis-Gravel, MD, MSc
        • Sub-Investigator:
          • Jean Grégoire, MD
        • Sub-Investigator:
          • François Simard, MD
        • Sub-Investigator:
          • Rafaël Monet-Alarcia, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Adult patients hospitalized at the Cardiac Care Unit at the Montreal Heart Institute.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Variation in LDL
Time Frame: Day 0 to day 2
Evaluation of the variation in LDL levels during a hospital admission for myocardial infarction
Day 0 to day 2

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Variation in non-HDL and apoB
Time Frame: Day 0 to day 2
Evaluation of the variation in non-HDL and apoB levels during a hospital admission for myocardial infarction
Day 0 to day 2
Evaluation of intensification threshold
Time Frame: Day 0 to day 2
Among the subgroup of patients who are already treated with lipid-lowering therapy at the time of admission, the proportion of patients with a LDL, non-HDL or apoB value above the intensification threshold
Day 0 to day 2

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Repeat lipid panel after discharge
Time Frame: 4-6 weeks
Evaluation of the proportion of patients discharged after myocardial infarction who undergo a repeat lipid panel after discharge
4-6 weeks
Evaluation of intensification threshold after discharge
Time Frame: 4-6 weeks
Evaluation of the proportion of patients discharged after MI with a LDL, non-HDL or apoB value above the intensification threshold after discharge
4-6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Montreal Heart Institute

Collaborators

Novartis Pharmaceuticals

Investigators

  • Principal Investigator: Guillaume Marquis-Gravel, MD, MSc, Montreal Heart Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

April 24, 2024

First Submitted That Met QC Criteria

April 24, 2024

First Posted (Actual)

April 29, 2024

Study Record Updates

Last Update Posted (Actual)

April 29, 2024

Last Update Submitted That Met QC Criteria

April 24, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICM 2025-3428

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Myocardial Infarction

Clinical Trials on Lipid panel

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Jordan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe