POCUS Screening for TAA in Hypertensive Patients in the ED | NCT06854588

Studies
POCUS Screening for TAA in Hypertensive Patients in the ED

NCT06854588

Sponsor

Chinese University of Hong Kong

Status

Not yet recruiting

Last Update Posted

Mar 13, 2025Actual

Enrollment

1,483Estimated

Phase

Not provided

Conditions

Thoracic Aortic Aneurysm (TAA)
Aortic Dissection

Interventions

Point-of-care ultrasound

Countries

Hong Kong

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2025Estimated

Primary Completion Date

Dec 2025Estimated

Completion Date

Feb 2026Estimated

First Submitted Date

Feb 12, 2025

First Submission Date that Met QC Criteria

Feb 25, 2025

First Posted Date

Mar 3, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 11, 2025

Last Update Posted Date

Mar 13, 2025Actual

Name	Class
Hospital Authority, Hong Kong	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,483Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Point-of-care ultrasound	Diagnostic Test	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.

Outcomes Module

Primary Outcomes

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 Outcomes

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 Outcomes

Measure	Description	Time Frame
BMI for all participants	BMI in kg/m^2	at the time of recruitment
number of CTA scans	number of CTA scans conducted for TAA confirmation

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Colin A. Graham, Professor	Contact	+852 35051698		cagraham@cuhk.edu.hk
Rebecca Li, MSc	Contact	35051698		rebecca_1229@link.cuhk.edu.hk

Overall Officials

Name	Affiliation	Role
Colin A Graham, Professor	Accident and Emergency Medicine Academic Unit, CUHK	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Prince of Wales Hospital		Shatin	NT		Hong Kong

IPD Sharing Statement Module

Plan to Share IPD

Description

Not allowed by the ethics committee

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D017545	Aortic Aneurysm, Thoracic
D000784	Aortic Dissection

Ancestor Terms

ID	Term
D001014	Aortic Aneurysm
D000783	Aneurysm
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

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Browse Branches

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