Screening for Abdominal Aortic Aneurysm and Popliteal Artery Aneurysm

Aortic Aneurysm, Abdominal Clinical Trial

— DAAP-PR  

Official title:

Screening for Abdominal Aortic Aneurysm and Popliteal Artery Aneurysm in At-risk Population (DAAP-PR Study)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05360108
• Other study ID #: DAAP-PR study
• Status: Recruiting
• Start date: June 1, 2020
• Est. completion date: June 30, 2028

Study information

• Verified date: March 2024
• Source: Centre Hospitalier Universitaire Vaudois
• Contact: Adriano Alatri, MD
• Phone: +41795565725
• Email: adriano.alatri[@]chuv.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Observational, prospective, cohort study to evaluate, by an opportunistic screening program based on vascular ultrasound, the prevalence and characteristics of Abdominal Aortic Aneurysm (AAA) and Popliteal Artery Aneurysm (PAA) in a female population as well as the prevalence and characteristics of PAA in male population.

Description:

Abdominal aortic aneurysm (AAA) remains a highly topical issue given the potentially dramatic consequences associated with its rupture. In men, the prevalence of AAA is declining, probably due to improved management of risk factors. However, the most recent studies and international recommendations have reaffirmed that screening for AAA in men is still important and cost-effective. In contrast, data regarding the risk and characteristics of AAA in women are very limited and outdated. For this reason, the recommendations are contrasting and not univocal. About 35% of patients with AAA have a second aneurysm more distally. Popliteal artery aneurysm (PAA) is the most common. Like AAA, PAA is often asymptomatic and its main complication is thrombotic occlusion resulting in acute/chronic ischemia of the affected limb and a high prevalence of permanent sequelae (mainly amputation). Data on epidemiology and risk factors of PAA are very limited in men and absent in women. In addition, the benefit of PAA screening has never been assessed so far.

The aim of this study is to evaluate, by an opportunistic screening program based on vascular ultrasound, the prevalence and characteristics of AAA and PAA in a female population as well as the prevalence and characteristics of PAA in male population. The project represents the first screening program for popliteal aneurysm. Finally, the results will allow us to better assess need for and modalities of a screening program.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: June 30, 2028
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 85 Years

Eligibility

Inclusion Criteria:

• Women aged =65 years who are current smokers

• Men aged =65 years

• Women or Men aged =55 years with family history (first-degree relatives) for Abdominal Aortic Aneurysm (AAA) or popliteal artery aneurysm (PAA)

Exclusion Criteria:

• Patient with known diagnosis of AAA or PAA

• Patient already operated for AAA or PAA

• AAA/PAA screening or arterial assessment of lower limbs within the last 12 months

• Inability to understand and/or sign study consent

• Inability to access follow-up controls

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal
• Popliteal Artery Aneurysm

Locations

Country	Name	City	State
Italy	Ospedale di Castelfranco Veneto, UOC Angiologia	Castelfranco Veneto	TV
Switzerland	Centre Hospitalier Universitaire Vaudois (CHUV), Service d'Angiologie	Lausanne	VD

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Vaudois

Countries where clinical trial is conducted

Italy,  Switzerland, 

References & Publications (6)

Aboyans V, Bataille V, Bliscaux P, Ederhy S, Filliol D, Honton B, Kurtz B, Messas E, Mohty D, Brochet E, Kownator S; investigators of the E2T3A study. Effectiveness of screening for abdominal aortic aneurysm during echocardiography. Am J Cardiol. 2014 Oct 1;114(7):1100-4. doi: 10.1016/j.amjcard.2014.07.024. Epub 2014 Jul 18. — View Citation

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. — View Citation

Farber A, Angle N, Avgerinos E, Dubois L, Eslami M, Geraghty P, Haurani M, Jim J, Ketteler E, Pulli R, Siracuse JJ, Murad MH. The Society for Vascular Surgery clinical practice guidelines on popliteal artery aneurysms. J Vasc Surg. 2022 Jan;75(1S):109S-120S. doi: 10.1016/j.jvs.2021.04.040. Epub 2021 May 20. — View Citation

Matsumura Y, Ochi Y, Wada M, Hirakawa D, Yamanaka S, Kamioka M, Kitaoka H, Orihashi K, Nakaoka Y, Doi Y, Sugiura T. Usefulness of Screening for Abdominal Aortic Aneurysm During Transthoracic Echocardiography in Women >/=50 Years of Age. Am J Cardiol. 2018 Dec 15;122(12):2147-2150. doi: 10.1016/j.amjcard.2018.08.050. Epub 2018 Sep 22. — View Citation

Svensjo S, Mani K, Bjorck M, Lundkvist J, Wanhainen A. Screening for abdominal aortic aneurysm in 65-year-old men remains cost-effective with contemporary epidemiology and management. Eur J Vasc Endovasc Surg. 2014 Apr;47(4):357-65. doi: 10.1016/j.ejvs.2013.12.023. Epub 2014 Jan 31. — View Citation

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. Erratum In: Eur J Vasc Endovasc Surg. 2020 Mar;59(3):494. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Abdominal aortic measurement	Ultrasound of infrarenal aorta with diameter measured in mm	1 day
Primary	Popliteal artery measurement	Ultrasound of popliteal artery with diameter measured in mm	1 day
Secondary	Smoking habits	Defined by active smoking, former smoking, never smoking	1 day
Secondary	Other cardiovascular risk factors	Arterial hypertension, Diabetes, Dyslipidemia, Obesity	1 day
Secondary	History of cardiovascular diseases	Coronary artery disease, cerebrovascular disease, lower extremity peripheral artery disease, venous thromboembolism	1 day
Secondary	Family history for aneurysmal disease	First-degree relatives with aneurysmal disease	1 day
Secondary	Time-consuming	Time needed to perform screening	1 day
Secondary	Surgical intervention for aneurysm	Number of aneurysm operated during follow-up	36 months