Clinical Characteristics and Prognosis of Aortic Dissection in China (CLASSIC) (CLASSIC)
July 10, 2024 updated by: First Affiliated Hospital Xi'an Jiaotong University
Clinical Characteristics and Prognosis of Aortic Dissection in China (CLASSIC): a National, Multicenter, Retrospective-prospective, Cohort Study
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.
Study Overview
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 Type
Observational
Enrollment (Estimated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Guoliang Li
- Phone Number: 0086-029-13759982523
- Email: liguoliang_med@163.com
Study Contact Backup
- Name: Yang Yan
- Email: yangyan3@mail.xjtu.edu.cn
Study Locations
-
-
Shaanxi
-
Xi'an, Shaanxi, China, 710061
- Recruiting
- First Affiliated Hospital of Xian Jiantong University
-
Contact:
- Guoliang Li
- Email: liguoliang_med@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
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.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Aortic dissection group
Patients diagnosed with aortic dissection at any of the centres and regularly consulted and followed up.
|
No interventions will be given to patients.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change of post-operative survival rate
Time Frame: 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.
|
3, 6, 9 month and 1, 2, 3, 4, 5 year after the surgery.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change of the incidence of MACCE
Time Frame: 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.
|
3, 6, 9 month and 1, 2, 3, 4, 5 year after the surgery.
|
|
Incidence of any complications
Time Frame: 5 years after the surgery.
|
Any complications diagnosed by doctors.
The occurrence of complications will be decided by medical records.
|
5 years after the surgery.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Guoliang Li, First Affiliated Hospital Xi'an Jiaotong University
- Principal Investigator: Yang Yan, First Affiliated Hospital Xi'an Jiaotong University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 30, 2023
Primary Completion (Estimated)
October 12, 2030
Study Completion (Estimated)
December 12, 2030
Study Registration Dates
First Submitted
August 13, 2023
First Submitted That Met QC Criteria
August 13, 2023
First Posted (Actual)
August 21, 2023
Study Record Updates
Last Update Posted (Actual)
July 12, 2024
Last Update Submitted That Met QC Criteria
July 10, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- XJTU1AF2023LSK-313
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.