Lipid Testing After Myocardial Infarction at the Montreal Heart Institute

Myocardial Infarction Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06388668
• Other study ID #: ICM 2025-3428
• Status: Not yet recruiting
• Start date: June 2024
• Est. completion date: September 2025

Study information

• Verified date: April 2024
• Source: Montreal Heart Institute
• Contact: Suzy Otis
• Phone: (514) 376-3330
• Email: suzy.otis[@]icm-mhi.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: September 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dyslipidemias
• Infarction
• Lipid Testing
• Myocardial Infarction

Intervention

Diagnostic Test:
• Lipid panel
Lipid panel measuring levels of LDL, non-HDL and apoB

Locations

Country	Name	City	State
Canada	Montreal Heart Institute	Montréal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Montreal Heart Institute	Novartis Pharmaceuticals

Country where clinical trial is conducted

Canada, 

References & Publications (9)

Anderson TJ, Gregoire J, Pearson GJ, Barry AR, Couture P, Dawes M, Francis GA, Genest J Jr, Grover S, Gupta M, Hegele RA, Lau DC, Leiter LA, Lonn E, Mancini GB, McPherson R, Ngui D, Poirier P, Sievenpiper JL, Stone JA, Thanassoulis G, Ward R. 2016 Canadian Cardiovascular Society Guidelines for the Management of Dyslipidemia for the Prevention of Cardiovascular Disease in the Adult. Can J Cardiol. 2016 Nov;32(11):1263-1282. doi: 10.1016/j.cjca.2016.07.510. Epub 2016 Jul 25. — View Citation

Elbarouni B, Banihashemi SB, Yan RT, Welsh RC, Kornder JM, Wong GC, Anderson FA, Spencer FA, Grondin FR, Goodman SG, Yan AT; Canadian Global Registry of Acute Coronary Events (GRACE/GRACE(2)) and Canadian Registry of Acute Coronary Events (CANRACE) Investigators. Temporal patterns of lipid testing and statin therapy in acute coronary syndrome patients (from the Canadian GRACE Experience). Am J Cardiol. 2012 May 15;109(10):1418-24. doi: 10.1016/j.amjcard.2012.01.352. Epub 2012 Mar 3. — View Citation

Gouda P, Welsh RC, Padarath M, Gregoire JC, Hegele RA, Gupta M. Landscape of Lipid Management Following an Acute Coronary Syndrome Event: Survey of Canadian Specialists. CJC Open. 2020 Aug 31;2(6):625-631. doi: 10.1016/j.cjco.2020.08.009. eCollection 2020 Nov. — View Citation

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. — View Citation

Pitt B, Loscalzo J, Ycas J, Raichlen JS. Lipid levels after acute coronary syndromes. J Am Coll Cardiol. 2008 Apr 15;51(15):1440-5. doi: 10.1016/j.jacc.2007.11.075. — View Citation

Rosenson RS. Myocardial injury: the acute phase response and lipoprotein metabolism. J Am Coll Cardiol. 1993 Sep;22(3):933-40. doi: 10.1016/0735-1097(93)90213-k. — View Citation

Sachdeva A, Cannon CP, Deedwania PC, Labresh KA, Smith SC Jr, Dai D, Hernandez A, Fonarow GC. Lipid levels in patients hospitalized with coronary artery disease: an analysis of 136,905 hospitalizations in Get With The Guidelines. Am Heart J. 2009 Jan;157(1):111-117.e2. doi: 10.1016/j.ahj.2008.08.010. Epub 2008 Oct 22. — View Citation

Sud M, Han L, Koh M, Abdel-Qadir H, Austin PC, Farkouh ME, Godoy LC, Lawler PR, Udell JA, Wijeysundera HC, Ko DT. Low-Density Lipoprotein Cholesterol and Adverse Cardiovascular Events After Percutaneous Coronary Intervention. J Am Coll Cardiol. 2020 Sep 22;76(12):1440-1450. doi: 10.1016/j.jacc.2020.07.033. — View Citation

Wang WT, Hellkamp A, Doll JA, Thomas L, Navar AM, Fonarow GC, Julien HM, Peterson ED, Wang TY. Lipid Testing and Statin Dosing After Acute Myocardial Infarction. J Am Heart Assoc. 2018 Jan 25;7(3):e006460. doi: 10.1161/JAHA.117.006460. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Repeat lipid panel after discharge	Evaluation of the proportion of patients discharged after myocardial infarction who undergo a repeat lipid panel after discharge	4-6 weeks
Other	Evaluation of intensification threshold after discharge	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
Primary	Variation in LDL	Evaluation of the variation in LDL levels during a hospital admission for myocardial infarction	Day 0 to day 2
Secondary	Variation in non-HDL and apoB	Evaluation of the variation in non-HDL and apoB levels during a hospital admission for myocardial infarction	Day 0 to day 2
Secondary	Evaluation of intensification threshold	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