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Post STEMI Echo Registry

Prevalence of LVEF Non-recovery After Acute Myocardial Infarction

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05551065
Enrollment
50
Registered
2022-09-22
Start date
2022-07-22
Completion date
2024-01-03
Last updated
2022-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ST Elevation Myocardial Infarction

Keywords

ST Elevation Myocardial Infarction, low Left Ventricular Ejection Fraction

Brief summary

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.

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

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

Sponsors

Gormin Tan gtan
CollaboratorUNKNOWN
Chinese University of Hong Kong
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Left Ventricular Ejection Fraction (LVEF) assessment9 monthsLVEF 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

MeasureTime frameDescription
Death9 monthsDeath
NYHA heart failure class9 monthsClass 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 dysfunction9 monthsValvular dysfunction defined as one or more of the valves in your heart doesn't work properly, as evident by echo results

Countries

Hong Kong

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026