Preoperative Ankle-Brachial Index and Renal Adverse Events After Acute Type A Aortic Dissection Surgery

Association Between Preoperative Ankle-Brachial Index and Postoperative Renal Adverse Events in Patients With Acute Stanford Type A Aortic Dissection: A Single-Center Retrospective Cohort Study

This retrospective cohort study will evaluate whether a high preoperative ankle-brachial index is associated with postoperative renal adverse events in patients with acute Stanford type A aortic dissection who underwent surgical repair. The ankle-brachial index is a noninvasive vascular measurement that may reflect arterial stiffness and vascular calcification. A high ankle-brachial index may indicate abnormal vascular aging and impaired vascular compliance.

The study will use existing clinical data from patients treated at Nanjing First Hospital, Nanjing Medical University, between January 2021 and February 2024. No intervention will be assigned as part of this study. The primary aim is to examine the association between a preoperative ankle-brachial index of 1.4 or higher and the risk of acute kidney injury within 7 days after surgery.

Study Overview

Detailed Description

Acute Stanford type A aortic dissection is a life-threatening cardiovascular emergency that usually requires urgent surgical repair. Postoperative acute kidney injury is a common and clinically important complication after surgery for acute type A aortic dissection and is associated with worse short-term and long-term outcomes. Identification of preoperative vascular markers associated with postoperative renal adverse events may help improve perioperative risk stratification.

The ankle-brachial index is a simple, noninvasive measure calculated from systolic blood pressure measured at the ankle and arm. Although a low ankle-brachial index is commonly used to identify peripheral artery disease, an abnormally high ankle-brachial index, usually defined as 1.4 or higher, may reflect noncompressible arteries, medial arterial calcification, and increased arterial stiffness. These vascular abnormalities may be associated with impaired renal perfusion reserve and increased susceptibility to kidney injury after major cardiovascular surgery.

This is a single-center, retrospective observational cohort study. The study will include patients with acute Stanford type A aortic dissection who underwent surgical repair at Nanjing First Hospital, Nanjing Medical University, from January 2021 to February 2024. Clinical data will be obtained from existing medical records. No study-specific intervention, treatment allocation, or additional follow-up will be performed.

The main exposure is preoperative ankle-brachial index. Patients will be categorized according to whether they have a high ankle-brachial index, defined as an ankle-brachial index of 1.4 or higher. The primary outcome is postoperative acute kidney injury within 7 days after surgery. Renal outcomes will be assessed using routinely collected perioperative clinical and laboratory data.

The study will compare baseline characteristics, perioperative variables, and postoperative renal outcomes between patients with and without a high preoperative ankle-brachial index. Multivariable regression models will be used to evaluate the association between high ankle-brachial index and postoperative renal adverse events after adjustment for relevant clinical covariates. Additional analyses may assess the association between ankle-brachial index and the severity of postoperative renal injury, as well as the robustness of the findings in sensitivity analyses.

Study Type

Observational

Enrollment (Actual)

516

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Jiangsu
      • Nanjing, Jiangsu, China, 210006
        • Nanjing First Hospital, Nanjing Medical University

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population will include adult patients with acute Stanford type A aortic dissection who underwent surgical repair at Nanjing First Hospital, Nanjing Medical University, between January 2021 and February 2024. Eligible patients will be identified from existing hospital medical records. Patients will be included if preoperative ankle-brachial index data and perioperative renal function data are available.

Description

Inclusion Criteria:

  1. Patients diagnosed with acute Stanford type A aortic dissection.
  2. Patients who underwent surgical repair for acute Stanford type A aortic dissection at Nanjing First Hospital, Nanjing Medical University, between January 2021 and February 2024.
  3. Patients aged 18 years or older.
  4. Patients with available preoperative ankle-brachial index data.
  5. Patients with available perioperative renal function data for assessment of postoperative renal outcomes.

Exclusion Criteria:

  1. Patients younger than 18 years.
  2. Patients without available preoperative ankle-brachial index data.
  3. Patients without sufficient perioperative serum creatinine data to assess postoperative acute kidney injury.
  4. Patients with preoperative end-stage renal disease or maintenance dialysis.
  5. Patients with incomplete key clinical data required for the main analysis.

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
High Ankle-Brachial Index Group
Patients with acute Stanford type A aortic dissection who underwent surgical repair and had a preoperative ankle-brachial index of 1.4 or higher.
Preoperative ankle-brachial index was measured as part of routine clinical assessment. Patients were categorized according to whether the ankle-brachial index was 1.4 or higher. No intervention was assigned by the study protocol.
Reference Ankle-Brachial Index Group
Patients with acute Stanford type A aortic dissection who underwent surgical repair and had a preoperative ankle-brachial index lower than 1.4.
Preoperative ankle-brachial index was measured as part of routine clinical assessment. Patients were categorized according to whether the ankle-brachial index was 1.4 or higher. No intervention was assigned by the study protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Acute Kidney Injury
Time Frame: Within 7 days after surgery
Postoperative acute kidney injury was defined according to serum creatinine-based Kidney Disease: Improving Global Outcomes criteria. Acute kidney injury was identified if serum creatinine increased by at least 0.3 mg/dL within 48 hours after surgery or increased to at least 1.5 times the baseline value within 7 days after surgery.
Within 7 days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Acute Kidney Disease
Time Frame: Within 7 to 90 days after surgery
Postoperative acute kidney disease was assessed using postoperative renal function data after the acute kidney injury window, according to changes in serum creatinine and renal function during the postoperative period.
Within 7 to 90 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Yali Ge, Nanjing First Hospital, Nanjing Medical University

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 (Actual)

January 1, 2021

Primary Completion (Actual)

February 29, 2024

Study Completion (Actual)

February 29, 2024

Study Registration Dates

First Submitted

June 21, 2026

First Submitted That Met QC Criteria

June 21, 2026

First Posted (Actual)

June 25, 2026

Study Record Updates

Last Update Posted (Actual)

June 29, 2026

Last Update Submitted That Met QC Criteria

June 24, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared because this retrospective study uses existing hospital medical records containing sensitive clinical information. Data sharing is restricted by institutional policies and privacy considerations. De-identified aggregate results may be made available in the publication or from the corresponding author upon reasonable request, subject to institutional approval.

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.

Clinical Trials on Aortic Dissection Type A

Clinical Trials on Preoperative Ankle-Brachial Index

3
Subscribe