Post STEMI Echo Registry

NCT05551065 | Unknown

• 1 other identifier: 2022.038
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

ST Elevation Myocardial Infarction

Keywords

ST Elevation Myocardial Infarction; low Left Ventricular Ejection Fraction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Death

  9 months

• NYHA heart failure class

  9 months

• Valvular dysfunction

  9 months

Interventions

Point-of-care ultrasound (POCUS) DEVICE

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

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \> 18 years of age
• 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)
• Ability to provide informed consent and to complete the study and required follow-up

You may not qualify if:

• Pregnancy
• Pre-existing ICD or CRT-D implantation

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• Gormin Tan gtan: collaborator

Study Sites (1)

The Chinese University of Hong Kong

Shatin, 999077, Hong Kong

Location

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 9 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 16, 2022
• First Posted: September 22, 2022
• Study Start: July 22, 2022
• Primary Completion: January 1, 2024
• Study Completion: January 3, 2024
• Last Updated: September 26, 2022

Record last verified: 2022-09

Locations

HK (1)