Ta strona została przetłumaczona automatycznie i dokładność tłumaczenia nie jest gwarantowana. Proszę odnieść się do angielska wersja za tekst źródłowy.

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

11 listopada 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Szczegółowy opis

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.

Typ studiów

Obserwacyjny

Zapisy (Szacowany)

2000

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Nazwa: Mario A Fabiani, Doctor
Numer telefonu: +52 81 1918 8937
E-mail: alefabiani@gmail.com

Kopia zapasowa kontaktu do badania

Nazwa: Mauricio Gonzalez-Urquijo, Doctor
Numer telefonu: +52 81 1910 3675
E-mail: murquijo@tec.mx

Lokalizacje studiów

Meksyk
- Nuevo León
  - Monterrey, Nuevo León, Meksyk, 66278
    - Centro Médico Zambrano Hellion
    - Kontakt:
      
      Mario A Fabiani, MD
      
      Numer telefonu: +52 81 1918 8937
      
      E-mail: alefabiani@gmail.com
    - Kontakt:
      
      Mauricio Gonzalez-Urquijo, MD
      
      Numer telefonu: +52 81 1910 3675
      
      E-mail: murquijo@tec.mx
    - Główny śledczy:
      
      Mario A Fabiani, MD
    - Główny śledczy:
      
      Mauricio Gonzalez-Urquijo, MD
    - Pod-śledczy:
      
      Ricardo J Chavez, MD
    - Pod-śledczy:
      
      Isabela Andara, MD
Włochy
- Friuli Venezia Giulia
  - Trieste, Friuli Venezia Giulia, Włochy
    - University Hospital of Trieste
    - Kontakt:
      
      Mario G D'Oria, MD
      
      Numer telefonu: +393313281748
      
      E-mail: mario.doria88@outlook.com
    - Główny śledczy:
      
      Mario G D'Oria, MD

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

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.

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Modele obserwacyjne: CASE_CONTROL
Perspektywy czasowe: PROSPECTIVE

Kohorty i interwencje

Grupa / Kohorta Grupa / Kohorta Grupa lub podgrupa uczestników badania obserwacyjnego ocenianego pod kątem wyników biomedycznych lub zdrowotnych.
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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku	Opis środka	Ramy czasowe
Difference in Area Under the Receiver Operating Characteristic Curve Between Aortic Size Index and Maximum Aneurysm Diameter Ramy czasowe: 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 Ramy czasowe: 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)

Miary wyników drugorzędnych

Miara wyniku	Opis środka	Ramy czasowe
Proportion of Participants With Ruptured Abdominal Aortic Aneurysms Below the Sex-Specific Diameter Threshold Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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)

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Tecnologico de Monterrey

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 listopada 2026

Zakończenie podstawowe (Szacowany)

1 stycznia 2027

Ukończenie studiów (Szacowany)

1 maja 2028

Daty rejestracji na studia

Pierwszy przesłany

14 października 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

20 października 2026

Pierwszy wysłany (Rzeczywisty)

26 października 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

12 listopada 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

11 listopada 2026

Ostatnia weryfikacja

1 października 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

AASI-01

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu 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.

Kryteria dostępu do udostępniania 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.

Typ informacji pomocniczych dotyczących udostępniania IPD

PROTOKÓŁ BADANIA
SOK ROŚLINNY
ANALITYCZNY_KOD

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .