Post STEMI Echo Registry

Prevalence of LVEF Non-recovery After Acute Myocardial Infarction

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: ST Elevation Myocardial Infarction
• Intervention / Treatment: Device: Point-of-care ultrasound (POCUS)

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

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

Study Locations

• Hong Kong
  • Shatin, Hong Kong, 999077
    • The Chinese University of Hong Kong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The medical records of patients who have STEMI will be reviewed to determine preliminary eligibility according to patient inclusion/exclusion criteria. After a patient signs an informed consent for this study, he/she is considered enrolled in the study. An informed consent including privacy authorization must be obtained prior to the enrollment. The signed Patient Informed Consent should be kept with the study documentation and must be available for monitoring.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Left Ventricular Ejection Fraction (LVEF) assessment	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.	9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Death	Death	9 months
NYHA heart failure class	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.	9 months
Valvular dysfunction	Valvular dysfunction defined as one or more of the valves in your heart doesn't work properly, as evident by echo results	9 months

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Collaborators: Gormin Tan gtan

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 22, 2022
• Primary Completion (ANTICIPATED): January 1, 2024
• Study Completion (ANTICIPATED): January 3, 2024

Study Registration Dates

• First Submitted: September 16, 2022
• First Submitted That Met QC Criteria: September 19, 2022
• First Posted (ACTUAL): September 22, 2022

Study Record Updates

• Last Update Posted (ACTUAL): September 26, 2022
• Last Update Submitted That Met QC Criteria: September 22, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: ST Elevation Myocardial Infarction; low Left Ventricular Ejection Fraction
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; ST Elevation Myocardial Infarction
• Other Study ID Numbers: 2022.038

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