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

Aortic Dissection Clinical Trial

— CLASSIC  

Official title:

Clinical Characteristics and Prognosis of Aortic Dissection in China (CLASSIC): a National, Multicenter, Retrospective-prospective, Cohort Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05999188
• Other study ID #: XJTU1AF2023LSK-313
• Status: Not yet recruiting
• Start date: December 30, 2024
• Est. completion date: December 12, 2030

Study information

• Verified date: April 2024
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: Guoliang Li
• Phone: 0086-029-13759982523
• Email: liguoliang_med[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 12, 2030
• Est. primary completion date: October 12, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aortic Dissection

Intervention

Other:
• Observational
No interventions will be given to patients.

Locations

Country	Name	City	State
China	First Affiliated Hospital of Xian Jiantong University	Xi'an	Shaanxi

Sponsors (5)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University	521 Hospital of NORINCO Group, Henan Provincial People's Hospital, Shaanxi Provincial People's Hospital, Xiangyang Central Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of post-operative survival rate	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.	3, 6, 9 month and 1, 2, 3, 4, 5 year after the surgery.
Secondary	Change of the incidence of MACCE	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.	3, 6, 9 month and 1, 2, 3, 4, 5 year after the surgery.
Secondary	Incidence of any complications	Any complications diagnosed by doctors. The occurrence of complications will be decided by medical records.	5 years after the surgery.