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Aortic Size and Height Indices in Abdominal Aortic Aneurysms (AASI)

11 novembre 2026 aggiornato da: Mario Alejandro Fabiani, Tecnologico de Monterrey

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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Stimato)

2000

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Nome: Mario A Fabiani, Doctor
Numero di telefono: +52 81 1918 8937
Email: alefabiani@gmail.com

Backup dei contatti dello studio

Nome: Mauricio Gonzalez-Urquijo, Doctor
Numero di telefono: +52 81 1910 3675
Email: murquijo@tec.mx

Luoghi di studio

Italia
- Friuli Venezia Giulia
  - Trieste, Friuli Venezia Giulia, Italia
    - University Hospital of Trieste
    - Contatto:
      
      Mario G D'Oria, MD
      
      Numero di telefono: +393313281748
      
      Email: mario.doria88@outlook.com
    - Investigatore principale:
      
      Mario G D'Oria, MD
Messico
- Nuevo León
  - Monterrey, Nuevo León, Messico, 66278
    - Centro Médico Zambrano Hellion
    - Contatto:
      
      Mario A Fabiani, MD
      
      Numero di telefono: +52 81 1918 8937
      
      Email: alefabiani@gmail.com
    - Contatto:
      
      Mauricio Gonzalez-Urquijo, MD
      
      Numero di telefono: +52 81 1910 3675
      
      Email: murquijo@tec.mx
    - Investigatore principale:
      
      Mario A Fabiani, MD
    - Investigatore principale:
      
      Mauricio Gonzalez-Urquijo, MD
    - Sub-investigatore:
      
      Ricardo J Chavez, MD
    - Sub-investigatore:
      
      Isabela Andara, MD

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Modelli osservazionali: CASE_CONTROL
Prospettive temporali: PROSPECTIVE

Coorti e interventi

Gruppo / Coorte Gruppo / Coorte Un gruppo o sottogruppo di partecipanti a uno studio osservazionale che viene valutato per gli esiti biomedici o sanitari.
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
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato	Misura Descrizione	Lasso di tempo
Difference in Area Under the Receiver Operating Characteristic Curve Between Aortic Size Index and Maximum Aneurysm Diameter Lasso di tempo: 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)
Difference in Area Under the Receiver Operating Characteristic Curve Between Aortic Height Index and Maximum Aneurysm Diameter Lasso di tempo: Baseline (at the index presentation for abdominal aortic aneurysm and before any aneurysm intervention)	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)

Misure di risultato secondarie

Misura del risultato	Misura Descrizione	Lasso di tempo
Proportion of Participants With Ruptured Abdominal Aortic Aneurysms Below the Sex-Specific Diameter Threshold Lasso di tempo: Baseline (at the index presentation for abdominal aortic aneurysm and before any aneurysm intervention)	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)
Aortic Size Index by Rupture Status Lasso di tempo: Baseline (at the index presentation for abdominal aortic aneurysm and before any aneurysm intervention)	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)
Aortic Height Index by Rupture Status Lasso di tempo: Baseline (at the index presentation for abdominal aortic aneurysm and before any aneurysm intervention)	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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Tecnologico de Monterrey

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 novembre 2026

Completamento primario (Stimato)

1 gennaio 2027

Completamento dello studio (Stimato)

1 maggio 2028

Date di iscrizione allo studio

Primo inviato

14 ottobre 2026

Primo inviato che soddisfa i criteri di controllo qualità

20 ottobre 2026

Primo Inserito (Effettivo)

26 ottobre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

12 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

11 novembre 2026

Ultimo verificato

1 ottobre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

AASI-01

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano 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.

Criteri di accesso alla condivisione 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.

Tipo di informazioni di supporto alla condivisione IPD

STUDIO_PROTOCOLLO
LINFA
CODICE_ANALITICO

Informazioni su farmaci e dispositivi, documenti di studio

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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .