Aortic Dissection Type ANCT07668830
Preoperative Ankle-Brachial Index and Renal Adverse Events After Acute Type A Aortic Dissection Surgery
An observational study of Aortic Dissection Type A and Acute Kidney Injury Cardiac Surgery, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
Trial summary
This single-centre retrospective observational cohort study evaluated the association between preoperative cuff-derived ankle-brachial index (ABI) and postoperative acute kidney injury (AKI) in adults undergoing emergency repair of acute type A aortic dissection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Dissection Type A, Acute Kidney Injury Cardiac Surgery
- What is being tested?
- Preoperative Ankle-Brachial Index
- How many people
- 516 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 29 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population comprised consecutive adults with acute type A aortic dissection who underwent emergency open surgical repair at Nanjing First Hospital, Nanjing Medical University, between January 2019 and February 2024. Eligible patients were identified retrospectively from existing hospital medical records. Inclusion required routine preoperative four-limb cuff pressure measurements sufficient for ABI derivation and postoperative serum creatinine data sufficient for AKI ascertainment. Patients meeting the exclusion criteria applied during retrospective cohort selection, including ABI ≤0.90, advanced preoperative kidney dysfunction, severe preoperative heart failure, or imaging-confirmed renal or limb malperfusion, were excluded.
Who may be able to join
- Adults aged 18 years or older with acute type A aortic dissection.
- Underwent emergency open surgical repair at Nanjing First Hospital, Nanjing Medical University, between January 2019 and February 2024.
- Routine preoperative four-limb cuff pressure measurements sufficient for calculation of ABI.
- Postoperative serum creatinine measurements sufficient for ascertainment of AKI.
Who cannot join
- Non-standard or aborted repair, or insufficient intraoperative haemodynamic recordings for the planned analyses.
- Preoperative estimated glomerular filtration rate <30 ml min-1 1.73 m-2, maintenance dialysis, or end-stage kidney disease.
- Severe preoperative heart failure, defined as cardiogenic shock, mechanical circulatory support, left ventricular ejection fraction <30%, or New York Heart Association class IV.
- Previous peripheral or aortic intervention affecting ABI interpretation.
- Imaging-confirmed renal or limb malperfusion.
- ABI ≤0.90.
- For patients with more than one potentially eligible repair during the same admission, only the first eligible repair was included.
Trial locations and contacts
1 site in 1 country.
China1 site
Nanjing First Hospital, Nanjing Medical University
Nanjing, Jiangsu, 210006
About this study
Official 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
This single-centre retrospective observational cohort study evaluated the association between preoperative cuff-derived ankle-brachial index (ABI) and postoperative acute kidney injury (AKI) in adults undergoing emergency repair of acute type A aortic dissection. Existing clinical data from patients treated at Nanjing First Hospital, Nanjing Medical University, between January 2019 and February 2024 were used. High ABI was defined as >1.40, and the reference ABI range was defined as >0.90 and ≤1.40. The primary outcome was creatinine-defined AKI within 7 postoperative days. Exploratory analyses examined whether the association between cumulative intraoperative mean arterial pressure exposure and AKI differed according to ABI phenotype. No intervention or treatment allocation was assigned by the study protocol.
Read the detailed description
This single-centre retrospective observational cohort study used routinely collected electronic health records from adults undergoing emergency open repair of acute type A aortic dissection at Nanjing First Hospital, Nanjing Medical University, between January 2019 and February 2024. No study-specific intervention, treatment allocation, or additional clinical follow-up was performed.
The principal exposure was preoperative cuff-derived ankle-brachial index (ABI). ABI was calculated from routine four-limb oscillometric cuff pressures. Each ankle systolic pressure was divided by the higher brachial systolic pressure, and the higher of the two side-specific ABI values was used for patient classification. High ABI was defined as >1.40, and the reference ABI range was defined as >0.90 and ≤1.40. ABI was considered an indirect vascular phenotype marker rather than a direct measure of arterial stiffness or renal autoregulatory reserve.
The primary outcome was postoperative acute kidney injury (AKI) within 7 days, defined using serum creatinine-based Kidney Disease: Improving Global Outcomes criteria. Multivariable regression models were used to evaluate the association between high ABI and postoperative AKI after adjustment for relevant clinical and operative covariates.
In exploratory analyses, cumulative intraoperative mean arterial pressure (MAP) burden was quantified as the time-integrated area below thresholds of 65 and 80 mm Hg. These candidate thresholds were selected based on prior published literature and clinical considerations, rather than by screening thresholds for statistical significance in the present cohort. Interaction analyses assessed whether the association between cumulative MAP burden and postoperative acute kidney injury (AKI) differed according to preoperative ABI phenotype. These analyses were exploratory and hypothesis-generating, rather than confirmatory, and were not intended to identify physiological autoregulatory limits or optimal therapeutic blood-pressure targets.
- Being tested
- Preoperative Ankle-Brachial Index
- Keywords
- Ankle-Brachial Index, Acute Stanford Type A Aortic Dissection, Renal Adverse Events, Retrospective Cohort Study, Arterial Stiffness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative Ankle-Brachial IndexOther
Preoperative ABI was derived from routine four-limb oscillometric cuff pressure measurements. Each ankle systolic pressure was divided by the higher brachial systolic pressure, and the higher of the two side-specific ABI values was used for patient classification. High ABI was defined as >1.40 and reference ABI as >0.90 and ≤1.40. No intervention was assigned by the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| High Ankle-Brachial Index Group | Patients with acute type A aortic dissection who underwent emergency surgical repair and had a preoperative cuff-derived ABI >1.40. Receives: Other: Preoperative Ankle-Brachial Index | |
| Reference Ankle-Brachial Index Group | Patients with acute type A aortic dissection who underwent emergency surgical repair and had a preoperative cuff-derived ABI >0.90 and ≤1.40. Receives: Other: Preoperative Ankle-Brachial Index |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Acute Kidney Injury
Postoperative acute kidney injury (AKI) within seven days was defined according to the serum creatinine criteria of Kidney Disease: Improving Global Outcomes (KDIGO): an increase in serum creatinine of at least 0.3 mg/dL (26.5 μmol/L) within 48 hours or an increase to at least 1.5 times the baseline value within seven days. Baseline serum creatinine was defined as the earliest available value recorded at emergency department presentation or hospital admission. Urine-output criteria were not applied because complete urine-output data were unavailable.
Measured: Within 7 days after surgery
Secondary outcomes (1)
Postoperative Acute Kidney Disease
Postoperative acute kidney disease (AKD) was assessed using available serum creatinine measurements during postoperative days 8-90, relative to the preoperative reference creatinine. Assessment included patients who survived beyond postoperative day 7 and had at least one eligible creatinine measurement or a documented kidney replacement therapy event during the assessment period. AKD classification followed the criteria applied in the study analysis.
Measured: Within 8 to 90 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start1 Jan 2019
- Primary completion29 Feb 2024
- Study completion29 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Dissection Type AStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 516 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yali Ge, Study director, Nanjing First Hospital, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07668830
- Sponsor's protocol ID
- KY20260604-KS-05
- Status last verified
- Oct 2026
- First submitted
- 21 Jun 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07668830
- Acronym / sponsor ID
- KY20260604-KS-05
- Keywords
- Ankle-Brachial Index, Acute Stanford Type A Aortic Dissection, Renal Adverse Events, Retrospective Cohort Study, Arterial Stiffness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 516 participants (actual)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 29 Feb 2024 (actual)
- Study completion
- 29 Feb 2024 (actual)
- First posted
- 25 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This single-centre retrospective observational cohort study evaluated the association between preoperative cuff-derived ankle-brachial index (ABI) and postoperative acute kidney injury (AKI) in adults undergoing emergency repair of acute type A aortic dissection. Existing clinical data from patients treated at Nanjing First Hospital, Nanjing Medical University, between January 2019 and February 2024 were used. High ABI was defined as >1.40, and the reference ABI range was defined as >0.90 and ≤1.40. The primary outcome was creatinine-defined AKI within 7 postoperative days. Exploratory analyses examined whether the association between cumulative intraoperative mean arterial pressure exposure and AKI differed according to ABI phenotype. No intervention or treatment allocation was assigned by the study protocol.
Detailed description
This single-centre retrospective observational cohort study used routinely collected electronic health records from adults undergoing emergency open repair of acute type A aortic dissection at Nanjing First Hospital, Nanjing Medical University, between January 2019 and February 2024. No study-specific intervention, treatment allocation, or additional clinical follow-up was performed.
The principal exposure was preoperative cuff-derived ankle-brachial index (ABI). ABI was calculated from routine four-limb oscillometric cuff pressures. Each ankle systolic pressure was divided by the higher brachial systolic pressure, and the higher of the two side-specific ABI values was used for patient classification. High ABI was defined as >1.40, and the reference ABI range was defined as >0.90 and ≤1.40. ABI was considered an indirect vascular phenotype marker rather than a direct measure of arterial stiffness or renal autoregulatory reserve.
The primary outcome was postoperative acute kidney injury (AKI) within 7 days, defined using serum creatinine-based Kidney Disease: Improving Global Outcomes criteria. Multivariable regression models were used to evaluate the association between high ABI and postoperative AKI after adjustment for relevant clinical and operative covariates.
In exploratory analyses, cumulative intraoperative mean arterial pressure (MAP) burden was quantified as the time-integrated area below thresholds of 65 and 80 mm Hg. These candidate thresholds were selected based on prior published literature and clinical considerations, rather than by screening thresholds for statistical significance in the present cohort. Interaction analyses assessed whether the association between cumulative MAP burden and postoperative acute kidney injury (AKI) differed according to preoperative ABI phenotype. These analyses were exploratory and hypothesis-generating, rather than confirmatory, and were not intended to identify physiological autoregulatory limits or optimal therapeutic blood-pressure targets.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Ankle-Brachial Index Group | – | Other: Preoperative Ankle-Brachial IndexPatients with acute type A aortic dissection who underwent emergency surgical repair and had a preoperative cuff-derived ABI >1.40. |
| Reference Ankle-Brachial Index Group | – | Other: Preoperative Ankle-Brachial IndexPatients with acute type A aortic dissection who underwent emergency surgical repair and had a preoperative cuff-derived ABI >0.90 and ≤1.40. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population comprised consecutive adults with acute type A aortic dissection who underwent emergency open surgical repair at Nanjing First Hospital, Nanjing Medical University, between January 2019 and February 2024. Eligible patients were identified retrospectively from existing hospital medical records. Inclusion required routine preoperative four-limb cuff pressure measurements sufficient for ABI derivation and postoperative serum creatinine data sufficient for AKI ascertainment. Patients meeting the exclusion criteria applied during retrospective cohort selection, including ABI ≤0.90, advanced preoperative kidney dysfunction, severe preoperative heart failure, or imaging-confirmed renal or limb malperfusion, were excluded.
Key inclusion criteria (4 listed)
- Adults aged 18 years or older with acute type A aortic dissection.
- Underwent emergency open surgical repair at Nanjing First Hospital, Nanjing Medical University, between January 2019 and February 2024.
- Routine preoperative four-limb cuff pressure measurements sufficient for calculation of ABI.
- Postoperative serum creatinine measurements sufficient for ascertainment of AKI.
Key exclusion criteria (7 listed)
- Non-standard or aborted repair, or insufficient intraoperative haemodynamic recordings for the planned analyses.
- Preoperative estimated glomerular filtration rate <30 ml min-1 1.73 m-2, maintenance dialysis, or end-stage kidney disease.
- Severe preoperative heart failure, defined as cardiogenic shock, mechanical circulatory support, left ventricular ejection fraction <30%, or New York Heart Association class IV.
- Previous peripheral or aortic intervention affecting ABI interpretation.
- Imaging-confirmed renal or limb malperfusion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preoperative Ankle-Brachial IndexPreoperative ABI was derived from routine four-limb oscillometric cuff pressure measurements. Each ankle systolic pressure was divided by the higher brachial systolic pressure, and the higher of the two side-specific ABI values was used for patient classification. High ABI was defined as >1.40 and reference ABI as >0.90 and ≤1.40. No intervention was assigned by the study protocol. | Other | High Ankle-Brachial Index Group, Reference Ankle-Brachial Index Group |
Primary outcome
Postoperative Acute Kidney Injury
Time frame: Within 7 days after surgery
Postoperative acute kidney injury (AKI) within seven days was defined according to the serum creatinine criteria of Kidney Disease: Improving Global Outcomes (KDIGO): an increase in serum creatinine of at least 0.3 mg/dL (26.5 μmol/L) within 48 hours or an increase to at least 1.5 times the baseline value within seven days. Baseline serum creatinine was defined as the earliest available value recorded at emergency department presentation or hospital admission. Urine-output criteria were not applied because complete urine-output data were unavailable.
1 secondary outcome
Postoperative Acute Kidney Disease
Time frame: Within 8 to 90 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yali Ge study director
Nanjing First Hospital, Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Dissection Type A and Acute Kidney Injury Cardiac Surgery, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Acute Kidney Injury (time frame: Within 7 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.