- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05044494
Surgery for Delay-recognized or Defer-operated Type A Aortic Dissection
September 12, 2021 updated by: Mackay Memorial Hospital
From November 2004 to June 2020, there were more than 200 patients with acute TAAD patients who underwent aortic surgery at our hospital.Of all the patients in the study period, there were 34 patients (defined as study group) who sought for medical attention with symptoms for several days (median 5 days, range 3-7 days) or deferred aortic surgery several days later (median 3 days, range 2-7 days) even though acute TAAD was diagnosed on the same day when chest pain or back pain occurred.
For reducing the selection bias, propensity score matching (PSM) was used to match the study group with the control group from all the patients treated at our hospital during the study period.
Comparison between the two groups was performed.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
From November 2004 to June 2020, there were more than 200 patients with acute TAAD patients who underwent aortic surgery at our hospital.
The research protocol used in this study was approved by the institutional review board of MacKay Memorial Hospital (IRB number: 21MMHIS005e).
Of all the patients in the study period, there were 34 patients (defined as study group) who sought for medical attention with symptoms for several days (median 5 days, range 3-7 days) or deferred aortic surgery several days later (median 3 days, range 2-7 days) even though acute TAAD was diagnosed on the same day when chest pain or back pain occurred.
The mean age at presentation was 60.2 +/- 13.2 years (range 33.4~83.5 years).
All the patients in the study group were divided into 3 groups: DP group (n=22) with acute TAAD diagnosis delayed by patient but received prompt aortic surgery; DD group (n=4) with acute TAAD diagnosis delayed by patient and received deferred aortic surgery; ID group (n=8) with acute TAAD diagnosis on the same day when the symptoms occurred but received deferred aortic surgery several days later.
For reducing the selection bias, propensity score matching (PSM) was used to match the study group with the control group from all the patients treated at our hospital during the study period.
Comparison between the two groups was performed.
Study Type
Observational
Enrollment (Actual)
68
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
33 years to 83 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
From November 2004 to June 2020, there were more than 200 consecutive patients with acute TAAD treated surgically at our hospital.
Among all the acute TAAD patients, 34 patients sought for medical attention with symptoms (chest pain, back pain or shortness of breath) for several days or deferred aortic surgery several days later although acute TAAD was diagnosed on the same day when chest pain or back pain occurred.
Description
Inclusion Criteria:
- the patients sought for medical attention with symptoms (chest pain, back pain or shortness of breath) for several days or deferred aortic surgery several days later although acute TAAD was diagnosed on the same day when chest pain or back pain occurred
Exclusion Criteria:
-
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 |
---|---|
study group
non-prompt surgery after acute type a aortic dissection occurred
|
|
control group
prompt surgery after acute type a aortic dissection occurred
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
surgical mortality
Time Frame: 2004-2020
|
in-hospital death
|
2004-2020
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
November 1, 2004
Primary Completion (Actual)
June 1, 2020
Study Completion (Actual)
June 1, 2020
Study Registration Dates
First Submitted
September 12, 2021
First Submitted That Met QC Criteria
September 12, 2021
First Posted (Actual)
September 14, 2021
Study Record Updates
Last Update Posted (Actual)
September 14, 2021
Last Update Submitted That Met QC Criteria
September 12, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21MMHIS005e
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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