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
Procedure: non-prompt surgery
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

Mackay Memorial Hospital

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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