Preoperative BNP and MINS in AAA Open Repair

• Sponsor: Gangnam Severance Hospital (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT06088641
• Collaborator: (none)
• Enrollment: 198
• Location: 1
• Anticipated Duration (Months): 21.9
• Patients Per Site Per Month: 9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myocardial Injury After Non-cardiac Surgery	Diagnostic Test: preoperative BNP value

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 198 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Prognostic Impact of Preoperative B-type Natriuretic Peptide for Predicting Myocardial Injury After Non-cardiac Surgery in Patients Who Underwent Open Repair for Abdominal Aortic Aneurysm: a Retrospective Study
• Actual Study Start Date: Jan 1, 2022
• Actual Primary Completion Date: Mar 30, 2023
• Anticipated Study Completion Date: Oct 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Lower BNP preoperative Lower BNP	Diagnostic Test: preoperative BNP value; preoperative BNP value
Higher BNP preoperative higher BNP	Diagnostic Test: preoperative BNP value; preoperative BNP value

Outcome Measures

Primary Outcome Measures

1. MINS [30 days after surgery]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Exclusion Criteria:

1. Ruptured AAA

2. Traumatic aortic injury

3. Absence of troponin-T value within 30 days of surgery

4. Diagnosis of elevation of troponin-T due to non-ischemic cause (ex: sepsis, pulmonary embolism, atrial fibrillation, cardioversion, etc.)

5. Insufficient medical records

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gangnam severance Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

• Gangnam Severance Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sung Yeon Ham, professor, Gangnam Severance Hospital
• ClinicalTrials.gov Identifier: NCT06088641
• Other Study ID Numbers: 3-2023-0187
• First Posted: Oct 18, 2023
• Last Update Posted: Oct 18, 2023
• Last Verified: Oct 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Sung Yeon Ham, professor, Gangnam Severance Hospital: AAA; MINS; BNP

Study Results

No Results Posted as of Oct 18, 2023