Aortic DissectionNCT05044494
Surgery for Delay-recognized or Defer-operated Type A Aortic Dissection
An observational study of Aortic Dissection, run by Mackay Memorial Hospital.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 33 to 83 years
- Conditions the study is for
- Aortic Dissection
- What is being tested?
- non-prompt surgery
- Type of treatment
- Surgery or procedure
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- Nov 2004to Jun 2020
- 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 33 to 83 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- -
About this study
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.
Read the 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.
- Conditions
- Aortic Dissection
- Being tested
- non-prompt surgery
- Medical subject headings
- Aortic Dissection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-prompt surgeryProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| study group | non-prompt surgery after acute type a aortic dissection occurred Receives: Procedure: non-prompt surgery | |
| control group | prompt surgery after acute type a aortic dissection occurred |
What is being measured
The primary outcome is the main question the study is designed to answer.
surgical mortality
in-hospital death
Measured: 2004-2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2021
- Study startNov 2004
- Primary completionJun 2020
- Study completionJun 2020
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
- Retrospective
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mackay Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05044494
- Sponsor's protocol ID
- 21MMHIS005e
- Status last verified
- May 2021
- First submitted
- 12 Sep 2021
- Last updated
- 14 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgery for Delay-recognized or Defer-operated Type A Aortic Dissection
- ClinicalTrials.gov ID
- NCT05044494
- Acronym / sponsor ID
- 21MMHIS005e
- Conditions
- Aortic Dissection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Mackay Memorial HospitalUniversity, hospital or other
- Study start
- Nov 2004
- Primary completion
- Jun 2020 (actual)
- Study completion
- Jun 2020 (actual)
- First posted
- 14 Sep 2021 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | – | Procedure: non-prompt surgerynon-prompt surgery after acute type a aortic dissection occurred |
| control group | – | –prompt surgery after acute type a aortic dissection occurred |
Who may qualify
- Ages
- 33 to 83 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| non-prompt surgery | Procedure or surgery | study group |
Primary outcome
surgical mortality
Time frame: 2004-2020
in-hospital death
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 14 Sep 2021.
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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 Mackay Memorial Hospital.
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 1 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 14 Sep 2021. 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?
surgical mortality (time frame: 2004-2020). 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 14 Sep 2021.