Aortic Dissection Detection Risk Score With D-dimer to Rule-Out Acute Aortic Syndrome

June 8, 2026 updated by: Colin Graham, Chinese University of Hong Kong

The Combination of Aortic Dissection Detection Risk Score With D-dimer to Rule-Out Acute Aortic Syndrome: Multicentre Prospective Study in Emergency Departments

The goal of this study is to evaluate the safety of integrating the Aortic Dissection Detection Risk Score (ADD-RS) and D-dimer testing for ruling out acute aortic syndrome (AAS) in the emergency department (ED). The main question it aims to answer: Can the combination of the ADD-RS <2, and D dimer <500ng/mL rule-out AAS in ED patients without CTA? The researchers will recruit patients suspected with AAS in the ED, and the patients will receive a ADD-RS score, a D-dimer testing after signing a written consent.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
448

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Rebecca Li, Miss
  • Phone Number: 35051698

Study Locations

  • Hong Kong
      • Shatin, Hong Kong
        • Prince of Wales Hospital
        • Contact:
          • Rebecca Li
          • Phone Number: 35051698

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients presenting to the ED meeting the above criteria during the recruitment timeframe

Description

Inclusion Criteria:

  • Adult patients aged ≥ 18 years; AND
  • Presentation to the ED with any of the following symptoms: acute onset (<14 days) chest pain, abdominal pain, back pain, syncope, or signs of malperfusion (e.g. limb ischemia, neurological deficit); AND
  • AAS is considered as a possible differential diagnosis by the treating physician. Enrolment in the study will be determined by the attending physician during initial medical consultation in the ED and prior to establishing a final diagnosis.

Exclusion Criteria:

  • An alternative diagnosis to AAS established by the treating physician after the initial assessment; OR
  • Trauma cases; OR
  • Patients with a known diagnosis of AAS before the index ED visit (e.g. with a diagnostic imaging done before the ED visit or referral from other institutions for AAS); OR
  • Clinical severity or other conditions not allowing complete evaluation/proper enrolment; OR
  • Patient who refuse to participate.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
incidence of missed AAS within 30 days among patients identified as low risk (ADD-RS <2 and D-dimer <500 ng/mL) who did not undergo CTA
Time Frame: From enrollment to 30 days after index visit
number of patients with ADD-RS <2 and a negative D-dimer who were actually AAS cases
From enrollment to 30 days after index visit

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
sensitivity of the proposed algorithm
Time Frame: From enrolment to 30 days after the index visit
The sensitivity of using ADD-RS and D-dimer to rule out AAS without performing CTA in the ED
From enrolment to 30 days after the index visit

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
D-dimer levels in different subgroups
Time Frame: After completion of recruitment, estimated 18 months
D-dimer levels will be compared across different subgroups of AAS, including aortic dissection ,intramural hematoma and penetrating aortic ulcer.
After completion of recruitment, estimated 18 months
Hospital length of stay
Time Frame: From enrolment to 30 day follow-up
The number of days for patients staying in the hospital
From enrolment to 30 day follow-up
proportion of patients undergoing CT imaging
Time Frame: From enrolment til patient discharged from the ED, estimated within the day of enrolment
the percentage of patients underwent CT imaging in the ED
From enrolment til patient discharged from the ED, estimated within the day of enrolment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chinese University of Hong Kong

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Prince of Wales Hospital, Shatin, Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 13, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 4, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 10, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ADD-RS_D-dimer_Protocol_PWH_v1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data collected from this study is exclusively for our own institutional research purpose.

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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