Preoperative BNP and MINS in AAA Open Repair | NCT06088641

Studies
Preoperative BNP and MINS in AAA Open Repair

NCT06088641

Sponsor

Gangnam Severance Hospital

Status

Unknown status

Last Update Posted

Nov 18, 2023Actual

Enrollment

198Actual

Phase

Not provided

Conditions

Myocardial Injury After Non-cardiac Surgery

Interventions

preoperative BNP value

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2022Actual

Primary Completion Date

Mar 30, 2023Actual

Completion Date

Jul 6, 2024Estimated

First Submitted Date

Oct 6, 2023

First Submission Date that Met QC Criteria

Oct 12, 2023

First Posted Date

Oct 18, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 15, 2023

Last Update Posted Date

Nov 18, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of this study was to investigate whether preoperative B-type natriuretic peptides serves as an independent predictor of myocardial injury after non-cardiac surgery (MINS) in abdominal aortic aneurysm open repair.

Detailed Description

The incidence of MINS was compared between the lower BNP and higher BNP groups, and a stepwise logistic regression analysis was performed to evaluate the predictors for MINS.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

198Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lower BNP		preoperative Lower BNP	Diagnostic Test: preoperative BNP value
Higher BNP		preoperative higher BNP	Diagnostic Test: preoperative BNP value

Interventions

Name	Type	Description	Arm Group Labels	Other Names
preoperative BNP value	Diagnostic Test	preoperative BNP value	Higher BNP Lower BNP

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
MINS	MINS is defined as an elevated Troponin-T within 30 days of surgery. The patients were divided into two groups based on their preoperative BNP levels, and the incidence of MINS was compared between the two groups.	30 days after surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients who underwent open repair with AAA from September 2010 to October 2021

Exclusion Criteria:

Ruptured AAA
Traumatic aortic injury
Absence of troponin-T value within 30 days of surgery
Diagnosis of elevation of troponin-T due to non-ischemic cause (ex: sepsis, pulmonary embolism, atrial fibrillation, cardioversion, etc.)
Insufficient medical records

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

patients who underwent AAA open repair

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gangnam severance Hospital		Seoul			South Korea