Quick Recognition of Aortic Dissection

• Sponsor: Shanghai Zhongshan Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05699395
• Collaborator: (none)
• Enrollment: 600
• Location: 1
• Anticipated Duration (Months): 30
• Patients Per Site Per Month: 20

Study Details

Study Description

Brief Summary

This is an observational study that establishes a cohort of patients with high risk chest pain who have been identified by CTA for aortic dissection. We then used this cohort to validate the accuracy of identifying aortic dissection based on extremity oximetry and Doppler waveforms.

Condition or Disease	Intervention/Treatment	Phase
Aortic Dissection	Diagnostic Test: Non interventional

Study Design

• Study Type: Observational
• Anticipated Enrollment: 600 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Identification of Aortic Dissection Based on Pulse Oxygen and Ultrasound Doppler Waveforms
• Actual Study Start Date: Dec 1, 2022
• Anticipated Primary Completion Date: Dec 31, 2024
• Anticipated Study Completion Date: May 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Aortic Dissection	Diagnostic Test: Non interventional; No intervention
Non Aortic Dissection	Diagnostic Test: Non interventional; No intervention

Outcome Measures

Primary Outcome Measures

1. Diagnosis of aortic dissection [First 24-hours during emergency dapartment stay]

   aortic dissection confirmed by CTA

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All

Inclusion Criteria:

• High risk chest pain with CTA

Exclusion Criteria:

• shock

• coma

• severe peripheral vascular diseases

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zhongshan Hospital, Fudan University	Shanghai		China

Sponsors and Collaborators

• Shanghai Zhongshan Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shanghai Zhongshan Hospital
• ClinicalTrials.gov Identifier: NCT05699395
• Other Study ID Numbers: QRAD2022
• First Posted: Jan 26, 2023
• Last Update Posted: Jan 26, 2023
• Last Verified: Nov 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Aneurysm, Dissecting

Study Results

No Results Posted as of Jan 26, 2023