Clinical Characteristics and Prognosis of Aortic Dissection in China (CLASSIC)

Recruiting

• Conditions: Aortic Dissection
• Interventions: Other: Observational

• Registration Number: NCT05999188
• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University

Brief Summary

This study will construct a retrospective-prospective long-term follow-up cohort and management system for aortic dissection through a multicentre collaborative network. This study aims to investigate the disease characteristics, progression patterns, clinical features, natural course and factors affecting the disease course and prognosis of patients with aortic dissection by retrospectively collecting data and prospectively enrolling patients.

Detailed Description

This study aims to construct a retrospective-prospective long-term follow-up cohort and management system for aortic dissection through a multicentre collaborative network. The duration of the study will be divided into retrospective and prospective components. The retrospective study will collect cases of aortic dissection of different aetiologies from 2003-2022; the prospective study is expected to collect cases of aortic dissection from 2022-2030. The study is expected to assess the disease characteristics, progression patterns, clinical features, natural course and long-term prognosis of aortic coarctation.

Study Timeline

• Study First Submitted: 2023-08-13
• Study First Submitted QC: 2023-08-13
• Study First Posted: 2023-08-21
• Study Start: 2023-10-30
• Status Verified: 2024-04
• Last Update Submitted: 2024-07-10
• Last Update Posted: 2024-07-12
• Primary Completion: 2030-10-12
• Study Completion: 2030-12-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Age 18-80 years;
• Meet diagnostic criteria for aortic dissection.

Exclusion Criteria

• Age <18 years or >80 years;
• Women who are pregnant and breastfeeding;
• Patients and their families refuse or are unable to sign the informed consent form.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Aortic dissection group	Observational	Patients diagnosed with aortic dissection at any of the centres and regularly consulted and followed up.

Primary Outcome Measures

Name	Time	Method
Change of post-operative survival rate	3, 6, 9 month and 1, 2, 3, 4, 5 year after the surgery.	Post-operative survival rate of patients after aortic dissection surgery in 3, 6, 9 month and 1, 2, 3, 4, 5 year. The survival situation will be assessed by telephone follow-up.

Secondary Outcome Measures

Name	Time	Method
Change of the incidence of MACCE	3, 6, 9 month and 1, 2, 3, 4, 5 year after the surgery.	Major adverse cardio-cerebrovascular events included myocardial infarction, stroke, revascularization and all-cause death. The occurrence of MACCE will be assessed by telephone follow-up and medical records.
Incidence of any complications	5 years after the surgery.	Any complications diagnosed by doctors. The occurrence of complications will be decided by medical records.

Trial Locations

Locations (1)

First Affiliated Hospital of Xian Jiantong University; 🇨🇳 Xi'an, Shaanxi, China