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

Sponsor

First Affiliated Hospital Xi'an Jiaotong University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05999188

Collaborator

521 Hospital of NORINCO Group (Other), Shaanxi Provincial People's Hospital (Other), Xiangyang Central Hospital (Other), Henan Provincial People's Hospital (Other)

100

Enrollment

Location

85.4

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Aortic Dissection	Other: Observational

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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Other

Official Title:

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

Anticipated Study Start Date :

Oct 30, 2023

Anticipated Primary Completion Date :

Oct 12, 2030

Anticipated Study Completion Date :

Dec 12, 2030

Arms and Interventions

Arm	Intervention/Treatment
Aortic dissection group Patients diagnosed with aortic dissection at any of the centres and regularly consulted and followed up.	Other: Observational No interventions will be given to patients.

Arm

Intervention/Treatment

Aortic dissection group

Patients diagnosed with aortic dissection at any of the centres and regularly consulted and followed up.

Other: Observational

No interventions will be given to patients.

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	First Affiliated Hospital of Xian Jiantong University	Xi'an	Shaanxi	China	710061

Sponsors and Collaborators

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

Investigators

Principal Investigator: Guoliang Li, First Affiliated Hospital Xi'an Jiaotong University
Principal Investigator: Yang Yan, First Affiliated Hospital Xi'an Jiaotong University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

First Affiliated Hospital Xi'an Jiaotong University

ClinicalTrials.gov Identifier:

NCT05999188

Other Study ID Numbers:

XJTU1AF2023LSK-313

First Posted:

Aug 21, 2023

Last Update Posted:

Aug 21, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by First Affiliated Hospital Xi'an Jiaotong University

aortic dissection

clinical characteristics

prognosis

Additional relevant MeSH terms:

Aortic Dissection

Study Results

No Results Posted as of Aug 21, 2023