Aortic DissectionNCT05409469
Clinical Characteristics, Management Patterns and Outcomes of Type A Aortic Dissection: A Sino-US Comparative Cohort Analysis
An observational study of Aortic Dissection, run by Xin Chen.
Trial summary
This study constructed a retrospective cohort study by retrospectively analyzing the data of all patients with aortic dissection from January 1, 2012 to December 31, 2021 from the Cardiovascular Disease Registration System of Jiangsu Province in China and the data of similar diseases in recent years from National… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Dissection
- What is being tested?
- surgery
- Type of treatment
- Surgery or procedure
- How many people
- 11,550 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Dec 2021
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients with aortic dissection in Jiangsu Aortic Registry system of China from January 2012 to December 2021 and all patients with aortic dissection in National Inpatient Sample database of the United States from January 2015 to December 2019.
Who may be able to join
- 1.Clinical diagnosis of type A Aortic Dissection
Who cannot join
- age<18, age unknown,
- diagnosis of aortic aneurysm, transfer out within 1 day,
- unknown vital status at discharge;
- unknown treatment type: cardioplegia, valve or cardiac repair only without aortic repair or two types of treatments on different days
About this study
This study constructed a retrospective cohort study by retrospectively analyzing the data of all patients with aortic dissection from January 1, 2012 to December 31, 2021 from the Cardiovascular Disease Registration System of Jiangsu Province in China and the data of similar diseases in recent years from National Inpatient Sample database in the United States
- Conditions
- Aortic Dissection
- Being tested
- surgery
- Keywords
- Aortic Dissection, China, the United States
- Medical subject headings
- Aortic Dissection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgeryProcedure or surgery
surgery on patients with aortic dissection
| Study group | Role | What they receive |
|---|---|---|
| Chinese patients with aortic dissection | Clinical characteristics, management patterns and outcomes of type A aortic dissection in China. Receives: Procedure: surgery | |
| American patients with aortic dissection | Clinical characteristics, management patterns and outcomes of type A aortic dissection in the United States. Receives: Procedure: surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline data of patients with type A aortic dissection was assessed by SPSS 17.0
Baseline data of patients with type A aortic dissection included gender, age,height, weight, past medical history, family history, hospital costs, etc.
Measured: from 2015 to 2019
The main efficacy indicators was assessed by SPSS 17.0.
The main efficacy indicators included surgical procedures, surgical outcome (postoperative bleeding, ICU stay, extubation time), perioperative complications (including infection, bleeding, neurological complications, cardic complications, renal insufficiency, etc.), and postoperative mortality.
Measured: from 2015 to 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2022
- Study startJan 2012
- Primary completionDec 2021
- Study completionDec 2021
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.
- 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
- 11,550 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Xin Chen
- Sponsor type
- University, hospital or other
- Collaborators
- China Medical University, China
- Responsible party
- Sponsor-investigator, Xin Chen, Nanjing First Hospital, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05409469
- Sponsor's protocol ID
- NanjingFirst AAD
- Status last verified
- May 2022
- First submitted
- 20 May 2022
- Last updated
- 8 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 8 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Characteristics, Management Patterns and Outcomes of Type A Aortic Dissection: A Sino-US Comparative Cohort Analysis
- ClinicalTrials.gov ID
- NCT05409469
- Acronym / sponsor ID
- NanjingFirst AAD
- Conditions
- Aortic Dissection
- Keywords
- Aortic Dissection, China, the United States
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11,550 participants (actual)
- Lead sponsor
- Xin ChenUniversity, hospital or other
- Collaborators
- China Medical University, China
- Study start
- Jan 2012 (actual)
- Primary completion
- Dec 2021 (actual)
- Study completion
- Dec 2021 (actual)
- First posted
- 8 Jun 2022 (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 constructed a retrospective cohort study by retrospectively analyzing the data of all patients with aortic dissection from January 1, 2012 to December 31, 2021 from the Cardiovascular Disease Registration System of Jiangsu Province in China and the data of similar diseases in recent years from National Inpatient Sample database in the United States
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chinese patients with aortic dissection | – | Procedure: surgeryClinical characteristics, management patterns and outcomes of type A aortic dissection in China. |
| American patients with aortic dissection | – | Procedure: surgeryClinical characteristics, management patterns and outcomes of type A aortic dissection in the United States. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with aortic dissection in Jiangsu Aortic Registry system of China from January 2012 to December 2021 and all patients with aortic dissection in National Inpatient Sample database of the United States from January 2015 to December 2019.
Key inclusion criteria (1 listed)
- 1.Clinical diagnosis of type A Aortic Dissection
Key exclusion criteria (4 listed)
- age<18, age unknown,
- diagnosis of aortic aneurysm, transfer out within 1 day,
- unknown vital status at discharge;
- unknown treatment type: cardioplegia, valve or cardiac repair only without aortic repair or two types of treatments on different days
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 |
|---|---|---|
| surgerysurgery on patients with aortic dissection | Procedure or surgery | American patients with aortic dissection, Chinese patients with aortic dissection |
Primary outcome
Baseline data of patients with type A aortic dissection was assessed by SPSS 17.0
Time frame: from 2015 to 2019
Baseline data of patients with type A aortic dissection included gender, age,height, weight, past medical history, family history, hospital costs, etc.
The main efficacy indicators was assessed by SPSS 17.0.
Time frame: from 2015 to 2019
The main efficacy indicators included surgical procedures, surgical outcome (postoperative bleeding, ICU stay, extubation time), perioperative complications (including infection, bleeding, neurological complications, cardic complications, renal insufficiency, etc.), and postoperative mortality.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2022.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Dissection, run by Xin Chen.
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 1 inclusion and 4 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: finished, as of the sponsor's last update on 8 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline data of patients with type A aortic dissection was assessed by SPSS 17.0 (time frame: from 2015 to 2019). The study lists 2 primary outcomes in all. 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 8 Jun 2022.