このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

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.

調査の概要

詳細な説明

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.

研究の種類

観察的

入学 (実際)

516

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • Jiangsu
      • Nanjing、Jiangsu、中国、210006
        • Nanjing First Hospital, Nanjing Medical University

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

サンプリング方法

非確率サンプル

調査対象母集団

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.

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

コホートと介入

グループ/コホート
介入・治療
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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Postoperative Acute Kidney Injury
時間枠: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

二次結果の測定

結果測定
メジャーの説明
時間枠
Postoperative Acute Kidney Disease
時間枠: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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

捜査官

  • スタディディレクター:Yali Ge、Nanjing First Hospital, Nanjing Medical University

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2021年1月1日

一次修了 (実際)

2024年2月29日

研究の完了 (実際)

2024年2月29日

試験登録日

最初に提出

2026年6月21日

QC基準を満たした最初の提出物

2026年6月21日

最初の投稿 (実際)

2026年6月25日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月29日

QC基準を満たした最後の更新が送信されました

2026年6月24日

最終確認日

2026年6月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

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.

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

購読する