Prospective Aortic Biobank of POP-STAR

NCT04269447 | Enrolling By Invitation

• 1 other identifier: EPN201904182
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 2

Brief Summary

The overall objective of the POP-STAR project is individualized surveillance for patients diagnosed with abdominal aortic aneurysms by means of more precise, patient-specific AAA growth prediction.

Conditions

Abdominal Aortic Aneurysm Without Rupture; Abdominal Aortic Aneurysm, Ruptured; Aortic Aneurysm; Aneurysm Abdominal; Aneurysm

Keywords

Growth Prediction; Rupture Risk Prediction; Imaging; Aortic disease; Vascular surgery; Vascular disease; Cardiovascular disease

Outcome Measures

Primary Outcomes (2)

• Aneurysm expansion rate

  Comparison of correctness of predicted growth (diameter vs ASI)

  Primary outcome evaluated at two years of follow-up.

• Aneurysm expansion rate

  Assessment if a more correct predicted growth alters surveillance (ASI vs diameter)

  Primary outcome second analysis at two years follow-up.

Interventions

Structured imaging follow-up DIAGNOSTIC_TEST

Structured imaging follow-up protocol with ultrasound (US) and computed tomography (CT) examinations as compared to current standard surveillance protocol for individualized estimations of AAA growth.

Also known as: Finite element analysis (FEA)

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All men and women diagnosed with an intact abdominal aortic aneurysm (AAA) and who fulfill the inclusion diameter criterion and none of the exclusion criteria are verified at the Department of Vascular Surgery, Karolinska University Hospital, Solna, and consecutively invited to participate.

You may qualify if:

• Abdominal aortic aneurysm 35-49 mm in men
• Abdominal aortic aneurysm 30-49 mm in women

You may not qualify if:

• Previous aortic or iliac surgery
• Present comorbidities with less than 2-years life expectancy
• Unable or unwilling to give informed consent
• Computed tomography examination with intravenous contrast contraindicated due to renal insufficiency (defined as creatinine/eGFR level XXX)

Sponsors & Collaborators

• Karolinska University Hospital: lead

Study Sites (2)

Department of Vascular Surgery, Karolinska University Hospital

Solna, Stockholm County, 171 76, Sweden

Location

Karolinska University Hospital

Stockholm, 17176, Sweden

Location

Related Publications (12)

• 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.

  PMID: 29268916 BACKGROUND

• Wanhainen A, Hultgren R, Linne A, Holst J, Gottsater A, Langenskiold M, Smidfelt K, Bjorck M, Svensjo S; Swedish Aneurysm Screening Study Group (SASS). Outcome of the Swedish Nationwide Abdominal Aortic Aneurysm Screening Program. Circulation. 2016 Oct 18;134(16):1141-1148. doi: 10.1161/CIRCULATIONAHA.116.022305. Epub 2016 Sep 14.

  PMID: 27630132 BACKGROUND

• Wanhainen A, Verzini F, Van Herzeele I, Allaire E, Bown M, Cohnert T, Dick F, van Herwaarden J, Karkos C, Koelemay M, Kolbel T, Loftus I, Mani K, Melissano G, Powell J, Szeberin Z, Esvs Guidelines Committee, de Borst GJ, Chakfe N, Debus S, Hinchliffe R, Kakkos S, Koncar I, Kolh P, Lindholt JS, de Vega M, Vermassen F, Document Reviewers, Bjorck M, Cheng S, Dalman R, Davidovic L, Donas K, Earnshaw J, Eckstein HH, Golledge J, Haulon S, Mastracci T, Naylor R, Ricco JB, Verhagen H. Editor's Choice - European Society for Vascular Surgery (ESVS) 2019 Clinical Practice Guidelines on the Management of Abdominal Aorto-iliac Artery Aneurysms. Eur J Vasc Endovasc Surg. 2019 Jan;57(1):8-93. doi: 10.1016/j.ejvs.2018.09.020. Epub 2018 Dec 5. No abstract available.

  PMID: 30528142 BACKGROUND

• Sweeting MJ, Thompson SG, Brown LC, Powell JT; RESCAN collaborators. Meta-analysis of individual patient data to examine factors affecting growth and rupture of small abdominal aortic aneurysms. Br J Surg. 2012 May;99(5):655-65. doi: 10.1002/bjs.8707. Epub 2012 Mar 5.

  PMID: 22389113 BACKGROUND

• Polzer S, Gasser TC, Vlachovsky R, Kubicek L, Lambert L, Man V, Novak K, Slazansky M, Bursa J, Staffa R. Biomechanical indices are more sensitive than diameter in predicting rupture of asymptomatic abdominal aortic aneurysms. J Vasc Surg. 2020 Feb;71(2):617-626.e6. doi: 10.1016/j.jvs.2019.03.051. Epub 2019 Jun 5.

  PMID: 31176634 BACKGROUND

• Polzer S, Gasser TC. Biomechanical rupture risk assessment of abdominal aortic aneurysms based on a novel probabilistic rupture risk index. J R Soc Interface. 2015 Dec 6;12(113):20150852. doi: 10.1098/rsif.2015.0852.

  PMID: 26631334 BACKGROUND

• Siika A, Lindquist Liljeqvist M, Zommorodi S, Nilsson O, Andersson P, Gasser TC, Roy J, Hultgren R. A large proportion of patients with small ruptured abdominal aortic aneurysms are women and have chronic obstructive pulmonary disease. PLoS One. 2019 May 28;14(5):e0216558. doi: 10.1371/journal.pone.0216558. eCollection 2019.

  PMID: 31136570 BACKGROUND

• Zommorodi S, Roy J, Steuer J, Hultgren R. High proportion of known abdominal aortic aneurysm in patients with rupture indicates surveillance deficiency. J Vasc Surg. 2016 Oct;64(4):949-955.e1. doi: 10.1016/j.jvs.2016.04.007.

  PMID: 27666443 BACKGROUND

• Brown LC, Thompson SG, Greenhalgh RM, Powell JT; UK Small Aneurysm Trial Participants. Fit patients with small abdominal aortic aneurysms (AAAs) do not benefit from early intervention. J Vasc Surg. 2008 Dec;48(6):1375-81. doi: 10.1016/j.jvs.2008.07.014.

  PMID: 19118733 BACKGROUND

• Singh K, Bonaa KH, Jacobsen BK, Bjork L, Solberg S. Prevalence of and risk factors for abdominal aortic aneurysms in a population-based study : The Tromso Study. Am J Epidemiol. 2001 Aug 1;154(3):236-44. doi: 10.1093/aje/154.3.236.

  PMID: 11479188 BACKGROUND

• Scott RA, Bridgewater SG, Ashton HA. Randomized clinical trial of screening for abdominal aortic aneurysm in women. Br J Surg. 2002 Mar;89(3):283-5. doi: 10.1046/j.0007-1323.2001.02014.x.

  PMID: 11872050 BACKGROUND

• Sakalihasan N, Michel JB, Katsargyris A, Kuivaniemi H, Defraigne JO, Nchimi A, Powell JT, Yoshimura K, Hultgren R. Abdominal aortic aneurysms. Nat Rev Dis Primers. 2018 Oct 18;4(1):34. doi: 10.1038/s41572-018-0030-7.

  PMID: 30337540 BACKGROUND

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal; Rupture; Aortic Aneurysm; Aneurysm; Aortic Diseases; Vascular Diseases; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Professor, Senior Consultant Vascular Surgery

Study Record Dates

• First Submitted: December 5, 2019
• First Posted: February 13, 2020
• Study Start: November 18, 2019
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 8, 2026

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)