Skip to main content
OpenTrials
Completed

NCT Number: NCT07668830

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nanjing First Hospital, Nanjing Medical University

Nanjing, Jiangsu, 210006, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients diagnosed with acute Stanford type A aortic dissection.
  • 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.
  • Patients aged 18 years or older.
  • Patients with available preoperative ankle-brachial index data.
  • Patients with available perioperative renal function data for assessment of postoperative renal outcomes.

Exclusion criteria

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

Treatment and study plan

Preoperative Ankle-Brachial Index

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Nanjing First Hospital, Nanjing Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jun 25, 2026
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.