Clinical trial NCT06854588: POCUS Screening for TAA in Hypertensive Patients in the ED
Official title: Point-of-care Ultrasound Screening of Thoracic Aortic Aneurysm in Hypertensive Patients in the Emergency Department
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Thoracic Aortic Aneurysm (TAA)
Aortic Dissection
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Hospital Authority, Hong Kong
First posted: 2025-03-03
Enrollment: 1483
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: hypertensives patients attending the emergency department without known history of aortic diseases.

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: number of patients with a dilated aorta
timeFrame: Day 1
Secondary outcomes:
measure: number of patients with confirmed TAA
timeFrame: through study completion, an average of 1 year
Other outcomes:
measure: BMI for all participants
timeFrame: at the time of recruitment
measure: number of CTA scans
timeFrame: through study completion, an average of 1 year
measure: number of surgical interventions
timeFrame: from recruitment to 28 days after
measure: ICU and hospital length of stay
timeFrame: through study completion, an average of 1 year
measure: mortality
timeFrame: from recruitment to 28 days after
measure: proportion of adequate visualisation of POCUS studies obtained
timeFrame: up to 1 year
measure: agreement of aortic diameter measurement
timeFrame: from recruitment to 28 days after if CTA is performed
Locations:
city: Sha Tin
country: Hong Kong
facility: Prince of Wales Hospital
state: NT
Study officials:
affiliation: Accident and Emergency Medicine Academic Unit, CUHK
name: Colin A Graham, Professor
role: PRINCIPAL_INVESTIGATOR
References: