Post STEMI Echo Registry

Sponsor
Chinese University of Hong Kong (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05551065
Collaborator
Gormin Tan gtan (Other)
50
1
17.4
2.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
50 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Prevalence of LVEF Non-recovery After Acute Myocardial Infarction
Actual Study Start Date :
Jul 22, 2022
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Jan 3, 2024

Outcome Measures

Primary Outcome Measures

  1. Left Ventricular Ejection Fraction (LVEF) assessment [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 Outcome Measures

  1. Death [9 months]

    Death

  2. NYHA heart failure class [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.

  3. Valvular dysfunction [9 months]

    Valvular dysfunction defined as one or more of the valves in your heart doesn't work properly, as evident by echo results

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Chinese University of Hong Kong Shatin Hong Kong 999077

Sponsors and Collaborators

  • Chinese University of Hong Kong
  • Gormin Tan gtan

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Professor Bryan Ping Yen YAN, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT05551065
Other Study ID Numbers:
  • 2022.038
First Posted:
Sep 22, 2022
Last Update Posted:
Sep 26, 2022
Last Verified:
Sep 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Professor Bryan Ping Yen YAN, Professor, Chinese University of Hong Kong
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 26, 2022