Post STEMI Echo Registry

NCT ID: NCT05551065

Last Updated: 2022-09-26

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-07-22
• Study Completion Date: 2024-01-03

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

Conditions

ST Elevation Myocardial Infarction

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

Point-of-care ultrasound (POCUS)

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gormin Tan gtan

UNKNOWN

Sponsor Role: collaborator

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Professor Bryan Ping Yen YAN

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Chinese University of Hong Kong

Shatin, , Hong Kong

Countries

Hong Kong

Other Identifiers

2022.038

Identifier Type: -

Identifier Source: org_study_id