POCUS Screening for TAA in Hypertensive Patients in the ED

Point-of-care Ultrasound Screening of Thoracic Aortic Aneurysm in Hypertensive Patients in the Emergency Department

The investigators are going to recruit hypertensive patients in the emergency department of Prince of Wales Hospital. Point-of-care ultrasound of the aorta and measurements of the aortic diameter will be obtained. Other relevant clinical data will also be obtained for analysis. The primary outcome is the number of patients with a maximum aortic diameter of ≥ 4.5 cm and/or ≥ 50% localized enlarged diameter relative to the adjacent normal segment as indicated by POCUS.

Study Overview

• Status: Not yet recruiting
• Conditions: Aortic Dissection; Thoracic Aortic Aneurysm (TAA)
• Intervention / Treatment: Diagnostic test: Point-of-care ultrasound

Detailed Description

Investigators trained with point-of-care ultrasound (POCUS) will recruit hypertensive patients in the emergency department (ED) of Prince of Wales Hospital. POCUS will be performed using a handheld ultrasound device to visualise the aortic root, ascending aorta, aortic arch and descending aorta. Measurements of the diameter will be obtained from different segments of the thoracic aorta for analysis. The definition of aortic aneurysm is a maximum aortic diameter of ≥ 4.5 cm and/or ≥ 50% localized enlarged diameter relative to the adjacent normal segment as indicated by POCUS. The primary outcome is the prevalence of thoracic aortic aneurysm (TAA) in hypertensive patients in the ED. The secondary outcomes include the number of patients with confirmed TAA as verified by CTA, BMI for all participants, the number of CTA scans conducted for TAA confirmation, the number of surgical interventions performed among TAA patients, the ICU admission rate, ICU length of stay, hospital length of stay and mortality, proportion of adequate visualisation of POCUS studies obtained, agreement of aortic diameter measurement between CTA and POCUS, and signs and symptoms of TAA patients presenting to the ED. In addition, the investigators will assess the 28-day all-cause mortality and any advanced imaging done outside the ED.

• Study Type: Observational
• Enrollment (Estimated): 1483

Contacts and Locations

• Study Contact: Name: Colin A. Graham, Professor; Phone Number: +852 35051698; Email: cagraham@cuhk.edu.hk
• Study Contact Backup: Name: Rebecca Li, MSc; Phone Number: 35051698; Email: rebecca_1229@link.cuhk.edu.hk

Study Locations

• Hong Kong
  • NT
    • Sha Tin, NT, Hong Kong
      • Prince of Wales Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

hypertensives patients attending the emergency department without known history of aortic diseases.

Description

Inclusion Criteria:

• Adult patients aged ≥ 18 years attending the ED during the study period
• Known history of hypertension or newly diagnosed hypertension in the ED

Exclusion Criteria:

• Known history of aortic aneurysm or dissection
• Previous thoracic aortic interventions or endovascular stenting
• Patients in cardiopulmonary resuscitation
• Traumatic patients
• Patients refuse to participate the study

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
hypertensive patients presenting to the emergency department; Adult patients aged ≥ 18 years attending the ED during the study period; Known history of hypertension or newly diagnosed hypertension in the ED	Diagnostic test: Point-of-care ultrasound; POCUS screening will be conducted to measure the maximum diameters at end diastole of the aortic root, ascending aorta, aortic arch, and descending thoracic aorta.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of patients with a dilated aorta	is the number of patients with a maximum aortic diameter of ≥ 4.5 cm and/or ≥ 50% localized enlarged diameter relative to the adjacent normal segment as indicated by POCUS	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of patients with confirmed TAA	number of patients with confirmed TAA as verified by CTA	through study completion, an average of 1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
BMI for all participants	BMI in kg/m^2	at the time of recruitment
number of surgical interventions	number of surgical interventions performed among TAA patients	from recruitment to 28 days after
ICU and hospital length of stay	ICU and hospital length of stay among patients with treatment for TAA	through study completion, an average of 1 year
mortality	28-day mortality in both TAA and non-TAA patients	from recruitment to 28 days after
proportion of adequate visualisation of POCUS studies obtained	proportion of adequate visualisation of POCUS studies (%) obtained during the recruitment period	up to 1 year
agreement of aortic diameter measurement	agreement of aortic diameter measurement between CTA and POCUS in cm	from recruitment to 28 days after if CTA is performed
number of CTA scans	number of CTA scans conducted for TAA confirmation	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Collaborators: Hospital Authority, Hong Kong
• Investigators: Principal Investigator: Colin A Graham, Professor, Accident and Emergency Medicine Academic Unit, CUHK

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2025
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: February 12, 2025
• First Submitted That Met QC Criteria: February 25, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 11, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Dissection, Blood Vessel; Acute Aortic Syndrome; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Dissection; Aortic Aneurysm, Thoracic
• Other Study ID Numbers: NTEC-2024-753

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Not allowed by the ethics committee

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No