Abdominal Aortic AneurysmAASINCT07893704
Aortic Size and Height Indices in Abdominal Aortic Aneurysms
An observational study of Abdominal Aortic Aneurysm and Abdominal Aortic Aneurysm, Ruptured, run by Tecnologico de Monterrey at 1 site in Mexico.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Aortic Aneurysm, Abdominal Aortic Aneurysm, Ruptured, Abdominal Aortic Aneurysm Without Rupture
- How many people
- 2,000 participants
- Where
- 1 siteMexico
- Study dates
- Nov 2026to May 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site
Centro Médico Zambrano Hellion
Monterrey, Nuevo León, 66278
Mario A Fabiani, Doctor, +52 81 1918 8937, alefabiani@gmail.com
Mauricio Gonzalez-Urquijo, Doctor, +52 81 1910 3675, murquijo@tec.mx
About this study
Official title: 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:
Read more
- 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.
Read the detailed description
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.
- Conditions
- Abdominal Aortic Aneurysm, Abdominal Aortic Aneurysm, Ruptured, Abdominal Aortic Aneurysm Without Rupture
- Keywords
- Aortic Size Index, Aortic Height Index, Infrarenal Abdominal Aortic Aneurysm, Ruptured Abdominal Aortic Aneurysm
- Medical subject headings
- Aortic Aneurysm, Abdominal, Rupture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Area Under the Receiver Operating Characteristic Curve Between Aortic Size Index and Maximum Aneurysm Diameter
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.
Measured: 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
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.
Measured: Baseline (at the index presentation for abdominal aortic aneurysm and before any aneurysm intervention)
Secondary outcomes (3)
Proportion of Participants With Ruptured Abdominal Aortic Aneurysms Below the Sex-Specific Diameter Threshold
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.
Measured: Baseline (at the index presentation for abdominal aortic aneurysm and before any aneurysm intervention)
Aortic Size Index by Rupture Status
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.
Measured: Baseline (at the index presentation for abdominal aortic aneurysm and before any aneurysm intervention)
Aortic Height Index by Rupture Status
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.
Measured: Baseline (at the index presentation for abdominal aortic aneurysm and before any aneurysm intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Abdominal Aortic AneurysmStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tecnologico de Monterrey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mario Alejandro Fabiani, Tecnologico de Monterrey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07893704
- Sponsor's protocol ID
- AASI-01
- Acronym
- AASI
- Status last verified
- Oct 2026
- First submitted
- 14 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 34506899Jones 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.
PubMed 30293889Du 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.
PubMed 2520314Wanhainen 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.
PubMed 38307694Chaikof 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.
PubMed 29268916Mola 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.
PubMed 35483578
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aortic Size Index and Aortic Height Index in Abdominal Aortic Aneurysms: An International Multicenter Study
- ClinicalTrials.gov ID
- NCT07893704
- Acronym / sponsor ID
- AASI / AASI-01
- Conditions
- Abdominal Aortic Aneurysm, Abdominal Aortic Aneurysm, Ruptured, Abdominal Aortic Aneurysm Without Rupture
- Keywords
- Aortic Size Index, Aortic Height Index, Infrarenal Abdominal Aortic Aneurysm, Ruptured Abdominal Aortic Aneurysm
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Tecnologico de MonterreyUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 26 Oct 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.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Difference in Area Under the Receiver Operating Characteristic Curve Between Aortic Size Index and Maximum Aneurysm Diameter
Time frame: 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.
Difference in Area Under the Receiver Operating Characteristic Curve Between Aortic Height Index and Maximum Aneurysm Diameter
Time frame: 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.
3 secondary outcomes
Proportion of Participants With Ruptured Abdominal Aortic Aneurysms Below the Sex-Specific Diameter Threshold
Time frame: Baseline (at the index presentation for abdominal aortic aneurysm and before any aneurysm intervention)
Aortic Size Index by Rupture Status
Time frame: Baseline (at the index presentation for abdominal aortic aneurysm and before any aneurysm intervention)
Aortic Height Index by Rupture Status
Time frame: Baseline (at the index presentation for abdominal aortic aneurysm and before any aneurysm intervention)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- BackgroundFabiani 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.
- Background: PubMed 34506899Patel 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.
- Background: PubMed 30293889Jones 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.
- Background: PubMed 2520314Du 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.
- Background: PubMed 38307694Wanhainen 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.
- Background: PubMed 29268916Chaikof 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.
- Background: PubMed 35483578Mola 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.
- Individual participant dataSharing planned: Yes. 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.
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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.
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 Abdominal Aortic Aneurysm and Abdominal Aortic Aneurysm, Ruptured, run by Tecnologico de Monterrey at 1 site in Mexico.
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 5 inclusion and 6 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: opening soon, as of the sponsor's last update on 26 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 Mexico. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mario A Fabiani, Doctor (+52 81 1918 8937, alefabiani@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in Area Under the Receiver Operating Characteristic Curve Between Aortic Size Index and Maximum Aneurysm Diameter (time frame: Baseline (at the index presentation for abdominal aortic aneurysm and before any aneurysm intervention)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07893704, which also lists 7 linked publications.
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 26 Oct 2026.