Post STEMI Echo Registry

Overview

This is a prospective observational study of consecutive patients presenting with STEMI to the Prince of Wales Hospital over a 12-month period. All patients will receive standard of care including reperfusion and GDMT irrespective of study enrolment. Patient will be followed for 9 months after enrolled in this study. Point-of-care ultrasound (POCUS) using a hand-held ultrasound (Vscan, GE Healthcare) will be performed to assess baseline LVEF within 48 hours of admission. Patients with baseline moderate-to-severe LV dysfunction by visual POCUS assessment (i.e. LVEF <40%) will be recruited for follow-up LVEF assessment at 3 months. Patients with persistent LVEF <40% by POCUS will undergo formal echocardiography to confirm LVEF by either 2D area (Simpson's rule) and 3D volumetric measurements. In 9 month visit, patient's clinical data will be collected and no echo is needed during this visit.

Full Title of Study: “Prevalence of LVEF Non-recovery After Acute Myocardial Infarction”

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: January 1, 2024

Detailed Description

This is a prospective observational study of consecutive patients presenting with STEMI to the Prince of Wales Hospital over a 12-month period. All patients will receive standard of care including reperfusion and GDMT irrespective of study enrolment. Patient will be followed for 9 months after enrolled in this study. Point-of-care ultrasound (POCUS) using a hand-held ultrasound (Vscan, GE Healthcare) will be performed to assess baseline LVEF within 48 hours of admission. Patients with baseline moderate-to-severe LV dysfunction by visual POCUS assessment (i.e. LVEF <40%) will be recruited for follow-up LVEF assessment at 3 months. Patients with persistent LVEF <40% by POCUS will undergo formal echocardiography to confirm LVEF by either 2D area (Simpson's rule) and 3D volumetric measurements. In 9 month visit, patient's clinical data will be collected and no echo is needed during this visit. Categorical variables were presented in frequency tables and were compared using the Pearson Chi square test if all cell sizes were more than 5, or Fisher exact test if otherwise. Parametric and nonparametric continuous variables were expressed as mean ± SD and median (interquartile range) and were compared using the Student t test and Mann-Whitney U test, respectively. P<0.05 was considered statistically significant. All statistical analyses were performed using SPSS version 24.0

Interventions

  • Device: Point-of-care ultrasound (POCUS)
    • Point-of-care ultrasound (POCUS) using a hand-held ultrasound (Vscan, GE Healthcare)

Clinical Trial Outcome Measures

Primary Measures

  • LVEF assessment
    • Time Frame: 9 months
    • LVEF is equal or below 35% proved that patients have poor left ventricular ejection fraction. LVEF is 36-49% proved that ejection blood function of heart is below normal. LVEF is 50-75% proved that ejection blood function of heart is normal.

Secondary Measures

  • Death
    • Time Frame: 9 months
    • Death
  • NYHA heart failure class
    • Time Frame: 9 months
    • Class I – No symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc. Class II – Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. Class III – Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20-100 m).Comfortable only at rest. Class IV – Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients. No NYHA class listed or unable to determine.
  • Valvular dysfunction
    • Time Frame: 9 months
    • Valvular dysfunction defined as one or more of the valves in your heart doesn’t work properly, as evident by echo results

Participating in This Clinical Trial

Inclusion Criteria

1. > 18 years of age 2. STEMI (defined by symptoms of myocardial ischemia accompanied by persistent elevation of the ST segment on ECG and the subsequent rise of biomarkers of myocardial necrosis) 3. Ability to provide informed consent and to complete the study and required follow-up Exclusion Criteria:

1. Pregnancy 2. Pre-existing ICD or CRT-D implantation

Gender Eligibility: All

Minimum Age: 19 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Chinese University of Hong Kong
  • Collaborator
    • Gormin Tan gtan
  • Provider of Information About this Clinical Study
    • Principal Investigator: Professor Bryan Ping Yen YAN, Professor – Chinese University of Hong Kong

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