NCT07668830

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
516

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 29, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 29, 2024

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

June 21, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 25, 2026

Completed
Last Updated

June 29, 2026

Status Verified

June 1, 2026

Enrollment Period

3.2 years

First QC Date

June 21, 2026

Last Update Submit

June 24, 2026

Conditions

Keywords

Ankle-Brachial IndexAcute Stanford Type A Aortic DissectionRenal Adverse EventsRetrospective Cohort StudyArterial Stiffness

Outcome Measures

Primary Outcomes (1)

  • Postoperative Acute Kidney Injury

    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 Outcomes (1)

  • Postoperative Acute Kidney Disease

    Within 7 to 90 days after surgery

Study Arms (2)

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.

Other: Preoperative Ankle-Brachial Index

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.

Other: Preoperative Ankle-Brachial Index

Interventions

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.

High Ankle-Brachial Index GroupReference Ankle-Brachial Index Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanjing First Hospital, Nanjing Medical University

Nanjing, Jiangsu, 210006, China

Location

Study Officials

  • Yali Ge

    Nanjing First Hospital, Nanjing Medical University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2026

First Posted

June 25, 2026

Study Start

January 1, 2021

Primary Completion

February 29, 2024

Study Completion

February 29, 2024

Last Updated

June 29, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

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.

Locations