- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03424785
Long Term Clinical Implications in Chinese Patients With Aortic Intramural Hematoma
February 6, 2018 updated by: Han Yaling, MD, Shenyang Northern Hospital
Long Term Follow-up and Clinical Implications in Chinese Patients With Aortic Intramural Hematoma
The study evaluates outcomes of intramural hematomas after long-term follow up and establish predictive factors in Chinese population.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
270 intramural hematoma patients with clinical and imaging follow up were retrospectively studied in present study.
The primary endpoint was consisted of aortic disease-related death, aortic dissection, penetrating atherosclerotic aortic ulcer , thickening of aorta hematoma and aortic complications requiring surgical or endovascular treatment.
Study Type
Observational
Enrollment (Actual)
270
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
30 years to 87 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
From February 2003 to May 2017, 1770 consecutive patients were diagnosed with AAS at the General Hospital of Shenyang Military Region, including 270 IMH patients, of which 123 patients were retrospectively examined.
Thirty-nine patients presented with type A aortic IMH, and 84 presented with type B aortic IMH
Description
Inclusion Criteria:
- Type A aortic hematoma
- Type B aortic hematoma
Exclusion Criteria:
- Aortic without initial intimal flap formation.
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
- Observational Models: Cohort
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
hematoma thickness and a baseline MAD
Time Frame: 14years
|
Medication and short-term imaging are recommended for Chinese IMH patients with a hematoma thickness less than 10.45 mm and a baseline MAD less than 44.75 mm.
Rigorous medical observation should also be performed during the acute phase of IMH.
|
14years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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)
June 3, 2008
Primary Completion (Actual)
May 14, 2017
Study Completion (Actual)
May 14, 2017
Study Registration Dates
First Submitted
December 11, 2017
First Submitted That Met QC Criteria
February 6, 2018
First Posted (Actual)
February 7, 2018
Study Record Updates
Last Update Posted (Actual)
February 7, 2018
Last Update Submitted That Met QC Criteria
February 6, 2018
Last Verified
December 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SYNH-20171115
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.
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