- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04398992
Additive Anti-inflammatory Action for Aortopathy & Arteriopathy
October 18, 2023 updated by: Hong Liu, Nanjing Medical University
Clinical Outcome of Aortic Disease in the Chinese Patients
Aortic disease refers to the blood in the aortic lumen entering the aortic mediastinum from the tear of the aortic intima, separating the mediastinum and extending along the long axis of the aorta to form the true and false separation state of the aortic wall.
This disease is rare, and the incidence rate is 100 thousand to 200 thousand a year, with the peak age of 50-70 years old.
65%-70% patients died in the acute stage due to cardiac congestion and arrhythmia, so early diagnosis and treatment is very necessary.
The aim of this study is analyze clinical outcome of Chinese patients with acute aortic syndrome and aortic aneurysm.
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
Detailed Description
Aortic disease refers to the blood in the aortic lumen entering the aortic mediastinum from the tear of the aortic intima, separating the mediastinum and extending along the long axis of the aorta to form the true and false separation state of the aortic wall.
Risk factors for aortic dissection included hypertension, cystic necrosis or degeneration of the middle aorta, hereditary connective tissue disease, congenital two-lobe active pulse valve, arteritis, aneurysm, atherosclerosis and iatrogenic injury, etc.
The leading cause of aortic dissection is hypertension, and more than 75% of aortic dissection is associated with hypertension.Therefore, for hypertension patients to do a good job in the prevention and control of hypertension, pay attention to the regular use of antihypertensive drugs and monitoring blood pressure.
In case of sudden chest and back lacerations, the patient should be immobilized in bed, contacted with an ambulance and sent to the hospital for emergency treatment, so as to avoid greater risks.
The aim of this study is analyze clinical outcome of Chinese patients with acute aortic syndrome and aortic aneurysm.
Study Type
Observational
Enrollment (Estimated)
10000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Beijing, China
- Beijing Chaoyang Hospital
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Beijing, China
- Beijing Anzhen Hospital
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Bengbu, China
- The First Affiliated Hospital of Bengbu Medical College
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Changsha, China
- Xiangya Hospital Central South University
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Guangzhou, China
- Guangzhou Medical University
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Guilin, China
- the First Affiliated Hospital of Guilin Medical College
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Nanjing, China, 210029
- The First Affiliated Hospital of Nanjing Medical University
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Nanjing, China
- Nanjing First Hospital, Nanjing Medical University
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Qingdao, China
- The Affiliated Hospital of Qingdao University
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Shanghai, China
- Shanghai East Hospital
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Shantou, China
- The First Affiliated Hospital of Shantou University Medical College
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Tianjin, China
- Tianjin Chest Hospital
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Tianjin, China
- TEDA International Cardiovascular Hospital
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Xiamen, China
- Xiamen Cardiovascular Hospital
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Guangxi
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Nanning, Guangxi, China
- The First Affiliated Hospital of Guangxi Medical University
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Heilongjiang
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Harbin, Heilongjiang, China
- The Second Affiliated Hospital of Harbin Medical University
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Jiangsu
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Yangzhou, Jiangsu, China, 225001
- Subei People's Hospital of Jiangsu province
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Jiangxi
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Nanchang, Jiangxi, China, 300088
- The Second Affiliated Hospital of Nanchang University
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Shandong
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Jinan, Shandong, China, 250012
- Qilu Hospital of Shandong University
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Shanghai
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Shanghai, Shanghai, China
- Shanghai DeltaHealth Hospital
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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
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Chinese patients suffering dilated aortic disease
Description
Inclusion Criteria:
- aortic dissection
- Aortic aneurysm
Exclusion Criteria:
- No treatment was received;
- Died in the emergency room before surgery;
- Unwillingness to cooperation with study procedures or follow-up visits
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Operative mortality
Time Frame: 30 days after treatment
|
Operative mortality was defined as any death, regardless of cause, occurring whether within 30 days after surgery in or out of the hospital or after 30 days during the same hospitalization subsequent to the operation.
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30 days after treatment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Hong-jia Zhang, MD, Beijing Anzhen Hospital
- Principal Investigator: Si-chong Qian, Beijing Anzhen Hospital
- Principal Investigator: Hong Liu, Nanjing Medical 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)
January 1, 2016
Primary Completion (Estimated)
December 31, 2025
Study Completion (Estimated)
December 31, 2025
Study Registration Dates
First Submitted
May 19, 2020
First Submitted That Met QC Criteria
May 19, 2020
First Posted (Actual)
May 22, 2020
Study Record Updates
Last Update Posted (Actual)
October 19, 2023
Last Update Submitted That Met QC Criteria
October 18, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5A-Plan
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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.
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