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

NCT05999188 | Recruiting

• 1 other identifier: XJTU1AF2023LSK-313
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Dissection

Keywords

aortic dissection; clinical characteristics; prognosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change of the incidence of MACCE

  3, 6, 9 month and 1, 2, 3, 4, 5 year after the surgery.

• Incidence of any complications

  5 years after the surgery.

Study Arms (1)

Aortic dissection group

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

Other: Observational

Interventions

Observational OTHER

No interventions will be given to patients.

Aortic dissection group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who are aged 18-80 years and diagnosed with aortic dissection at any of the centre can be enrolled.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

First Affiliated Hospital of Xian Jiantong University

Xi'an, Shaanxi, 710061, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood, urine, faeces, other types of body fluids (e.g. pericardial fluid), surgical and biopsy collected tissue specimens.

MeSH Terms

Conditions

Aortic Dissection

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Dissection, Blood Vessel; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Acute Aortic Syndrome; Aortic Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Guoliang Li

  First Affiliated Hospital Xi'an Jiaotong University

  PRINCIPAL INVESTIGATOR

• Yang Yan

  First Affiliated Hospital Xi'an Jiaotong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guoliang Li

CONTACT

0086-029-13759982523; liguoliang_med@163.com

Yang Yan

CONTACT

yangyan3@mail.xjtu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2023
• First Posted: August 21, 2023
• Study Start: October 30, 2023
• Primary Completion (Estimated): October 12, 2030
• Study Completion (Estimated): December 12, 2030
• Last Updated: July 12, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)