Aortic Size and Height Indices in Abdominal Aortic Aneurysms (AASI)
Aortic Size Index and Aortic Height Index in Abdominal Aortic Aneurysms: An International Multicenter Study
The goal of this observational study is to learn whether adjusting abdominal aortic aneurysm (AAA) size for body size helps distinguish ruptured from intact aneurysms better than maximum aneurysm diameter alone. The study will evaluate the Aortic Size Index, which adjusts aneurysm diameter for body surface area, and the Aortic Height Index, which adjusts aneurysm diameter for height.
The main questions are:
- Do the Aortic Size Index or Aortic Height Index distinguish ruptured from intact AAAs better than maximum aneurysm diameter alone?
- What proportion of ruptured AAAs occur below the diameter thresholds of 55 millimeters for men and 50 millimeters for women?
- Do the findings vary according to sex, participating country, or participating center?
The study will include adults presenting with a ruptured infrarenal AAA and adults with an intact infrarenal AAA undergoing open surgical or endovascular repair. Participants will not receive an experimental treatment. Researchers will use computed tomography scans obtained before surgical or endovascular treatment and available height and weight measurements. No additional computed tomography scans will be required for the study.
Researchers will also collect clinical, operative, and mortality information. Vital status will be recorded during the repair procedure, during the index hospitalization, and at 30-day follow-up. For participants who undergo AAA repair, the 30-day period will begin on the date of repair. For participants who do not undergo repair, it will begin on the date of the index clinical presentation. The 30-day assessment will use institutional medical records or telephone contact when necessary.
Обзор исследования
Статус
Подробное описание
This is a prospective, observational, international, multicenter study with a case-control analytical design and 30-day mortality follow-up. Participants will be recruited consecutively from participating centers. Patients presenting with ruptured infrarenal abdominal aortic aneurysms will constitute the case group, regardless of whether repair is subsequently performed. Patients with intact infrarenal abdominal aortic aneurysms undergoing open surgical or endovascular repair will constitute the comparison group. No experimental intervention or treatment assignment will occur, and study procedures will not delay or interfere with emergency care.
Each participant will contribute one baseline aneurysm measurement obtained from the index computed tomography (CT) scan performed before surgical or endovascular intervention. Maximum aneurysm diameter will be measured in millimeters from outer wall to outer wall and perpendicular to the vessel centerline using multiplanar reconstruction. The measurement will be performed by a trained observer at the participating center and recorded without rounding.
Height and weight will be selected according to a prespecified measurement hierarchy. The source and date of each anthropometric value, its interval relative to the index CT scan, and whether weight was obtained before intravenous fluid or blood product administration for hemodynamic stabilization will be recorded. Post-resuscitation and postoperative weight will not be used. Body surface area will be calculated using the Du Bois formula. The Aortic Size Index will be calculated as maximum aneurysm diameter in centimeters divided by body surface area in square meters. The Aortic Height Index will be calculated as maximum aneurysm diameter in centimeters divided by height in meters.
A standardized quality-assurance process will be used across participating centers. One de-identified CT study will be randomly selected from each consecutive group of 50 enrolled participants for independent remeasurement by a designated reviewer at the coordinating center. The central reviewer will be blinded to the original local measurement. Both measurements will be retained for quality-control analysis, but the central measurement will not replace the original analytical measurement.
Study data will be entered into a centralized Research Electronic Data Capture (REDCap) database using coded participant identifiers. Direct identifiers will not be entered into the centralized database, and each center will maintain its identification key separately. REDCap will provide role-based access, an audit trail, automated data-validation rules, and standardized data export. Data completeness and consistency will be reviewed periodically, and participating centers will receive queries when clarification or correction is required.
Intraoperative and in-hospital mortality will be recorded. For participants who undergo abdominal aortic aneurysm repair, 30-day vital status will be assessed 30 days after repair. For participants who do not undergo repair, it will be assessed 30 days after the index clinical presentation. Vital status will be verified through institutional medical records or telephone contact when necessary and feasible.
The target enrollment is 2,000 participants. Statistical analyses will be performed using the R statistical software. Receiver operating characteristic curves will be used to evaluate the ability of maximum aneurysm diameter, Aortic Size Index, and Aortic Height Index to distinguish ruptured from intact aneurysms. Areas under the curve and paired differences will be estimated with 95% confidence intervals using a center-level cluster-aware bootstrap. Holm adjustment will be applied to the two primary comparisons, and the paired DeLong method will be used as a sensitivity analysis. Because the indexed measurements are mathematically derived from maximum aneurysm diameter, maximum diameter, Aortic Size Index, and Aortic Height Index will be evaluated in separate mixed-effects logistic regression models. The multicenter structure will be addressed using a random intercept for participating center.
Тип исследования
Регистрация (Оцененный)
Контакты и местонахождение
Контакты исследования
- Имя: Mario A Fabiani, Doctor
- Номер телефона: +52 81 1918 8937
- Электронная почта: alefabiani@gmail.com
Учебное резервное копирование контактов
- Имя: Mauricio Gonzalez-Urquijo, Doctor
- Номер телефона: +52 81 1910 3675
- Электронная почта: murquijo@tec.mx
Места учебы
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Friuli Venezia Giulia
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Trieste, Friuli Venezia Giulia, Италия
- University Hospital of Trieste
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Контакт:
- Mario G D'Oria, MD
- Номер телефона: +393313281748
- Электронная почта: mario.doria88@outlook.com
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Главный следователь:
- Mario G D'Oria, MD
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Nuevo León
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Monterrey, Nuevo León, Мексика, 66278
- Centro Médico Zambrano Hellion
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Контакт:
- Mario A Fabiani, MD
- Номер телефона: +52 81 1918 8937
- Электронная почта: alefabiani@gmail.com
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Контакт:
- Mauricio Gonzalez-Urquijo, MD
- Номер телефона: +52 81 1910 3675
- Электронная почта: murquijo@tec.mx
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Главный следователь:
- Mario A Fabiani, MD
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Главный следователь:
- Mauricio Gonzalez-Urquijo, MD
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Младший исследователь:
- Ricardo J Chavez, MD
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Младший исследователь:
- Isabela Andara, MD
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Метод выборки
Исследуемая популяция
The study population will comprise adult patients evaluated for infrarenal abdominal aortic aneurysms at hospitals participating in an international multicenter network. It will include patients presenting with ruptured infrarenal abdominal aortic aneurysms, regardless of whether repair is subsequently performed, and patients with intact infrarenal abdominal aortic aneurysms undergoing open surgical or endovascular repair. Eligible patients will be recruited prospectively and consecutively at each participating center until the target sample size is reached.
Описание
Inclusion Criteria:
- Age 18 years or older.
- Documented ruptured infrarenal abdominal aortic aneurysm (AAA) with adequate computed tomography (CT) imaging obtained before any surgical or endovascular intervention, regardless of whether repair is subsequently performed; or intact infrarenal AAA undergoing open surgical or endovascular repair.
- Availability of CT imaging of sufficient quality for standardized measurement of maximum aneurysm diameter.
- Availability of height and weight data obtained and documented according to the prespecified anthropometric measurement hierarchy, including the source and date of each measurement.
- Written informed consent from the participant or a legally authorized representative when required and feasible, according to the ethics-approved procedures applicable at each participating center.
Exclusion Criteria:
- Age younger than 18 years.
- Aneurysm not classified as infrarenal.
- Absence of adequate CT imaging obtained before any surgical or endovascular intervention, or imaging of insufficient quality to reliably measure maximum aneurysm diameter.
- Absence of any usable height or weight value from the prespecified anthropometric measurement hierarchy, precluding calculation of the Aortic Size Index (ASI) and Aortic Height Index (AHI).
- Active pregnancy at the time of enrollment.
- Refusal to participate or withdrawal of informed consent.
Учебный план
Как устроено исследование?
Детали дизайна
- Наблюдательные модели: CASE_CONTROL
- Временные перспективы: PROSPECTIVE
Когорты и вмешательства
Группа / когорта |
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Ruptured Infrarrenal Abdominal Aortic Aneurysm
Adults presenting with a documented ruptured infrarenal abdominal aortic aneurysm on pre-intervention CT imaging, regardless of whether surgical or endovascular repair is subsequently performed |
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Intact infrarenal Abdominal Aortic Aneurysm undergoing repair
Adults with an intact infrarenal abdominal aortic aneurysm undergoing open surgical or endovascular repair, including asymptomatic and symptomatic nonruptured cases. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Difference in Area Under the Receiver Operating Characteristic Curve Between Aortic Size Index and Maximum Aneurysm Diameter
Временное ограничение: Baseline (at the index presentation for abdominal aortic aneurysm and before any aneurysm intervention)
|
The discriminatory performance of the Aortic Size Index (ASI) and maximum aneurysm diameter for distinguishing ruptured from intact abdominal aortic aneurysms will be evaluated using receiver operating characteristic curves. The primary measure will be the paired difference between the areas under the receiver operating characteristic curves for ASI and maximum aneurysm diameter. The individual areas under the curves and their paired difference will be reported with 95% confidence intervals estimated using a center-level cluster-aware bootstrap. ASI is calculated as maximum aneurysm diameter in centimeters divided by body surface area in square meters. |
Baseline (at the index presentation for abdominal aortic aneurysm and before any aneurysm intervention)
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Difference in Area Under the Receiver Operating Characteristic Curve Between Aortic Height Index and Maximum Aneurysm Diameter
Временное ограничение: Baseline (at the index presentation for abdominal aortic aneurysm and before any aneurysm intervention)
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The discriminatory performance of the Aortic Height Index (AHI) and maximum aneurysm diameter for distinguishing ruptured from intact abdominal aortic aneurysms will be evaluated using receiver operating characteristic curves. The primary measure will be the paired difference between the areas under the receiver operating characteristic curves for AHI and maximum aneurysm diameter. The individual areas under the curves and their paired difference will be reported with 95% confidence intervals estimated using a center-level cluster-aware bootstrap. AHI is calculated as maximum aneurysm diameter in centimeters divided by height in meters. |
Baseline (at the index presentation for abdominal aortic aneurysm and before any aneurysm intervention)
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Proportion of Participants With Ruptured Abdominal Aortic Aneurysms Below the Sex-Specific Diameter Threshold
Временное ограничение: Baseline (at the index presentation for abdominal aortic aneurysm and before any aneurysm intervention)
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Among participants with ruptured infrarenal abdominal aortic aneurysms, the number and proportion with a maximum aneurysm diameter below the prespecified sex-specific threshold will be reported with a 95% confidence interval. The thresholds are 55 millimeters for men and 50 millimeters for women. Maximum aneurysm diameter will be measured on the index pre-intervention computed tomography scan. |
Baseline (at the index presentation for abdominal aortic aneurysm and before any aneurysm intervention)
|
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Aortic Size Index by Rupture Status
Временное ограничение: Baseline (at the index presentation for abdominal aortic aneurysm and before any aneurysm intervention)
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The Aortic Size Index (ASI), expressed in centimeters per square meter, will be calculated as maximum aneurysm diameter in centimeters divided by body surface area in square meters. ASI values will be summarized using the mean and standard deviation or the median and interquartile range, according to their distribution, and compared between participants presenting with ruptured abdominal aortic aneurysms and participants with intact abdominal aortic aneurysms undergoing repair. |
Baseline (at the index presentation for abdominal aortic aneurysm and before any aneurysm intervention)
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Aortic Height Index by Rupture Status
Временное ограничение: Baseline (at the index presentation for abdominal aortic aneurysm and before any aneurysm intervention)
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The Aortic Height Index (AHI), expressed in centimeters per meter, will be calculated as maximum aneurysm diameter in centimeters divided by height in meters. AHI values will be summarized using the mean and standard deviation or the median and interquartile range, according to their distribution, and compared between participants presenting with ruptured abdominal aortic aneurysms and participants with intact abdominal aortic aneurysms undergoing repair. |
Baseline (at the index presentation for abdominal aortic aneurysm and before any aneurysm intervention)
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Соавторы и исследователи
Спонсор
Публикации и полезные ссылки
Общие публикации
- Chaikof EL, Dalman RL, Eskandari MK, Jackson BM, Lee WA, Mansour MA, Mastracci TM, Mell M, Murad MH, Nguyen LL, Oderich GS, Patel MS, Schermerhorn ML, Starnes BW. The Society for Vascular Surgery practice guidelines on the care of patients with an abdominal aortic aneurysm. J Vasc Surg. 2018 Jan;67(1):2-77.e2. doi: 10.1016/j.jvs.2017.10.044.
- Du Bois D, Du Bois EF. A formula to estimate the approximate surface area if height and weight be known. 1916. Nutrition. 1989 Sep-Oct;5(5):303-11; discussion 312-3. No abstract available.
- Wanhainen A, Van Herzeele I, Bastos Goncalves F, Bellmunt Montoya S, Berard X, Boyle JR, D'Oria M, Prendes CF, Karkos CD, Kazimierczak A, Koelemay MJW, Kolbel T, Mani K, Melissano G, Powell JT, Trimarchi S, Tsilimparis N; ESVS Guidelines Committee; Antoniou GA, Bjorck M, Coscas R, Dias NV, Kolh P, Lepidi S, Mees BME, Resch TA, Ricco JB, Tulamo R, Twine CP; Document Reviewers; Branzan D, Cheng SWK, Dalman RL, Dick F, Golledge J, Haulon S, van Herwaarden JA, Ilic NS, Jawien A, Mastracci TM, Oderich GS, Verzini F, Yeung KK. Editor's Choice -- European Society for Vascular Surgery (ESVS) 2024 Clinical Practice Guidelines on the Management of Abdominal Aorto-Iliac Artery Aneurysms. Eur J Vasc Endovasc Surg. 2024 Feb;67(2):192-331. doi: 10.1016/j.ejvs.2023.11.002. Epub 2024 Jan 23.
- Fabiani MA, González-Urquijo M, Silva-Platas C, et al. Normal aortic diameters within the Mexican population and the impact of gender and ethnicity. Rev Mex Angiol. 2022;50(3):90-95. doi:10.24875/RMA.22000026.
- Patel PB, De Guerre LEVM, Marcaccio CL, Dansey KD, Li C, Lo R, Patel VI, Schermerhorn ML. Sex-specific criteria for repair should be utilized in patients undergoing aortic aneurysm repair. J Vasc Surg. 2022 Feb;75(2):515-525. doi: 10.1016/j.jvs.2021.08.060. Epub 2021 Sep 8.
- Jones GT, Sandiford P, Hill GB, Williams MJA, Khashram M, Tilyard MW, Hammond-Tooke GD, Krysa J, van Rij AM. Correcting for Body Surface Area Identifies the True Prevalence of Abdominal Aortic Aneurysm in Screened Women. Eur J Vasc Endovasc Surg. 2019 Feb;57(2):221-228. doi: 10.1016/j.ejvs.2018.08.048. Epub 2018 Oct 4.
- Mola AG, Diaz CT, Martins GG, Sari XT, Montoya SB. Editor's Choice - Systematic Review and Meta-Analysis of Normal Infrarenal Aortic Diameter in the General Worldwide Population and Changes in Recent Decades. Eur J Vasc Endovasc Surg. 2022 Jul;64(1):4-14. doi: 10.1016/j.ejvs.2022.04.014. Epub 2022 Apr 26.
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- AASI-01
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
De-identified individual participant data that underlie the results reported in the primary and secondary study publications will be shared, together with the corresponding data dictionary. Shared data may include demographic and anthropometric variables, aneurysm measurements and derived indices, clinical presentation, treatment characteristics, and recorded outcomes. Direct identifiers, local patient-identification keys, and variables that could reasonably permit participant re-identification will not be shared.
Критерии совместного доступа к IPD
Qualified researchers may request access for scientifically and ethically sound research proposals. Requests will be reviewed by the Principal Investigator and the AASI Study Coordinating Team. Access will be granted after approval of the proposed use, confirmation of ethics approval when applicable, and execution of a data-use agreement prohibiting participant re-identification, unauthorized sharing, and use beyond the approved research purpose. Data will be transferred through a secure mechanism.
Совместное использование IPD Поддерживающий тип информации
- STUDY_PROTOCOL
- САП
- АНАЛИТИЧЕСКИЙ_КОД
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .