A Study to Evaluate the Impact of Long-term Digital Education vs Standard of Care on LDL-C Levels in Post Myocardial Infarction Patients

NCT06548555 | Completed

• 1 other identifier: CKJX839A1CZ01
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 5

Brief Summary

The purpose of this study is to demonstrate the impact of digital education on the cardiovascular risk factors in post-Myocardial Infarction patients and to generate evidence for broad implementation of the proposed education program.

Conditions

Myocardial Infarction

Keywords

myocardial infarction; MI; Czech Republic; secondary prevention; digital education; LDL-C

Outcome Measures

Primary Outcomes (2)

• Absolute change in LDL-C levels from baseline at month 12

  Absolute change in LDL-C levels from baseline at month 12 after the event.

  Baseline, month 12

• Relative (percentage) change in LDL-C levels from baseline at month 12

  Relative change in LDL-C levels from baseline at month 12 after the event.

  Baseline, month 12

Secondary Outcomes (28)

• Percentage of patients achieving their LDL-C target level

  Month 12

• Change in total cholesterol from Baseline at Month 12

  Baseline, month 12

• Change in HDL-C from Baseline at month 12

  Baseline, month 12

• Change in VLDL-C from Baseline at month 12

  Baseline, month 12

• Change in non-HDL-C from Baseline at month 12

  Baseline, month 12

Study Arms (2)

Interventional arm

Patients receiving the systematic educational intervention

Other: systematic educational intervention

Control arm

Patients treated in the clinical routine mode (the education of the patient follows routine practice and no added education is provided by the Healthcare Professionals).

Interventions

systematic educational intervention OTHER

This is a non-interventional study and does not impose a therapy protocol, or a diagnostic/therapeutic procedure. Patients are treated according to the local prescribing information, and routine medical practice in terms of visit frequency and types of assessments performed and only these data is collected as part of the study.

Interventional arm

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients after the first myocardial infarction.

You may qualify if:

• Male or female patients ≥18 years of age,
• At the Screening Visit, participants must be hospitalized for the first myocardial infarction. This must be a spontaneous MI (either ST-elevation MI or non-ST-elevation MI), which was not the result of percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG). Confirmation of MI is a combination of signs or symptoms consistent with presentation of MI, and at least one of the following (adapted from (Thygesen, et al., 2018)):
• Documentation of cardiac biomarkers that exceed the diagnostic threshold of a local laboratory for MI
• Pathological Q waves on ECG or other ECG changes as defined in Appendix 2
• Imaging evidence of loss of viable myocardium or regional wall motion abnormality in a pattern consistent with an infarction or ischemic etiology
• Identification of a coronary thrombus by angiography at the time of presentation with MI,
• LDL-C ≥ 1.8 mmol/L at the time of the hospitalization,
• Ability to participate in the hybrid educational program (must be able to receive emails and watch online educational videos),
• Patients must provide written consent to participate in the study.

You may not qualify if:

• History of previous myocardial infarction,
• History of previous coronary intervention due to ASCVD (percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG)),
• History of ischemic stroke,
• Any surgical or medical condition, which in the opinion of the investigator, may place the participant at higher risk from his/her participation in the study, or is likely to prevent the participant from complying with the requirements of the study or completing the study,
• Patients diagnosed with homozygous familial hypercholesterolemia,
• Unwillingness or inability (e.g., physical, or cognitive) to comply with study procedures (including adherence to study visits and fasting blood draws) and schedule,
• Participation in any other interventional study, both treatment and non-treatment interventional study,
• Patients treated with inclisiran prior to the hospitalization for myocardial infarction.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (5)

Novartis Investigative Site

Brno-Bohunice, 625 00, Czechia

Location

Novartis Investigative Site

České Budějovice, 370 01, Czechia

Location

Novartis Investigative Site

Ostrava Poruba, 708 52, Czechia

Location

Novartis Investigative Site

Prague, 12808, Czechia

Location

Novartis Investigative Site

Prague, 150 30, Czechia

Location

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2024
• First Posted: August 12, 2024
• Study Start: March 8, 2023
• Primary Completion: October 24, 2024
• Study Completion: October 24, 2024
• Last Updated: December 13, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (5)