Viewing Study NCT05044494


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Study NCT ID: NCT05044494
Status: COMPLETED
Last Update Posted: 2021-09-14
First Post: 2021-09-12
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Surgery for Delay-recognized or Defer-operated Type A Aortic Dissection
Sponsor: Mackay Memorial Hospital
Organization:

Study Overview

Official Title: Surgery for Delay-recognized or Defer-operated Type A Aortic Dissection
Status: COMPLETED
Status Verified Date: 2021-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: