Aortic DissectionCLASSICNCT05999188
Clinical Characteristics and Prognosis of Aortic Dissection in China (CLASSIC)
An observational study of Aortic Dissection, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Aortic Dissection
- What is being tested?
- Observational
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 30 Oct 2023to 12 Dec 2030
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are aged 18-80 years and diagnosed with aortic dissection at any of the centre can be enrolled.
Who may be able to join
- Age 18-80 years;
- Meet diagnostic criteria for aortic dissection.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Yang Yan contact
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Xian Jiantong University
Xi'an, Shaanxi, 710061
Guoliang Li, liguoliang_med@163.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Aortic Dissection
- Being tested
- Observational
- Keywords
- aortic dissection, clinical characteristics, prognosis
- Medical subject headings
- Aortic Dissection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
No interventions will be given to patients.
| Study group | Role | What they receive |
|---|---|---|
| Aortic dissection group | Patients diagnosed with aortic dissection at any of the centres and regularly consulted and followed up. Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3, 6, 9 month and 1, 2, 3, 4, 5 year after the surgery.
Secondary outcomes (2)
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.
Measured: 3, 6, 9 month and 1, 2, 3, 4, 5 year after the surgery.
Incidence of any complications
Any complications diagnosed by doctors. The occurrence of complications will be decided by medical records.
Measured: 5 years after the surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start30 Oct 2023
- Primary completion12 Oct 2030 (estimated)
- Study completion12 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic DissectionStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 100 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- 521 Hospital of NORINCO Group, Shaanxi Provincial People's Hospital, Xiangyang Central Hospital, Henan Provincial People's Hospital
- Responsible party
- Sponsor
- Investigators
- Guoliang Li, Principal investigator, First Affiliated Hospital Xi'an Jiaotong UniversityYang Yan, Principal investigator, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05999188
- Sponsor's protocol ID
- XJTU1AF2023LSK-313
- Acronym
- CLASSIC
- Status last verified
- Apr 2024
- First submitted
- 13 Aug 2023
- Last updated
- 12 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Characteristics and Prognosis of Aortic Dissection in China (CLASSIC): a National, Multicenter, Retrospective-prospective, Cohort Study
- ClinicalTrials.gov ID
- NCT05999188
- Acronym / sponsor ID
- CLASSIC / XJTU1AF2023LSK-313
- Conditions
- Aortic Dissection
- Keywords
- aortic dissection, clinical characteristics, prognosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Collaborators
- 521 Hospital of NORINCO Group, Shaanxi Provincial People's Hospital, Xiangyang Central Hospital, Henan Provincial People's Hospital
- Study start
- 30 Oct 2023 (actual)
- Primary completion
- 12 Oct 2030 (estimated)
- Study completion
- 12 Dec 2030 (estimated)
- First posted
- 21 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aortic dissection group | – | Other: ObservationalPatients diagnosed with aortic dissection at any of the centres and regularly consulted and followed up. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are aged 18-80 years and diagnosed with aortic dissection at any of the centre can be enrolled.
Key inclusion criteria (2 listed)
- Age 18-80 years;
- Meet diagnostic criteria for aortic dissection.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationalNo interventions will be given to patients. | Other | Aortic dissection group |
Primary outcome
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.
2 secondary outcomes
Change of the incidence of MACCE
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yang Yan contact
Guoliang Li principal investigator
First Affiliated Hospital Xi'an Jiaotong University
Yang Yan principal investigator
First Affiliated Hospital Xi'an Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Dissection, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guoliang Li (0086-029-13759982523, liguoliang_med@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of post-operative survival rate (time frame: 3, 6, 9 month and 1, 2, 3, 4, 5 year after the surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2024.