NCT02306304

Brief Summary

The study aims at screening Israeli Arab men, smokers or past smokers, for abdominal aortic aneurysms (AAA). The screening is to be performed at the family doctors clinics in the rural arab erea of the north of Israel. Goals: The investigators aim at revealing the actual prevalence of AAA in the Israeli Arab smoking men population. By revealing this prevalence we believe the need for a nation-wide screening program for AAA will turn available for assessment. In addition, the goal of improving the accessibility of health services for the Israeli Arab population is a key issue in the design of the research. 2000 patients are to be enrolled in the study over a period of 2 years. Each of the patients will be examined once for a duplex ultra-sound and will be classified into one of 4 sub-groups according to the maximal aortic diameter found.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
913

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 26, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 3, 2014

Completed
29 days until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

February 9, 2017

Status Verified

February 1, 2017

Enrollment Period

2 years

First QC Date

November 26, 2014

Last Update Submit

February 7, 2017

Conditions

Abdominal Aortic Aneurysm (AAA)

Keywords

Abdominal aortic aneurysmAbdominal aortic aneurismAAAScreeningduplex ultra soundIsraeli Arab menfamily physician

Outcome Measures

Primary Outcomes (1)

  • Abdominal aortic aneurysm prevalence in the represented population

    At the end of enrollment, estimated time - 2 years, the prevalence will be assessed.

    2 years

Study Arms (1)

Israeli Arab men

OTHER

Single arm study. The arm includes all enrolled patients screened by duplex ultra sound for abdominal aortic aneurysms.

Other: Duplex ultra sound screening for abdominal aortic aneurysms

Interventions

Duplex ultra sound screening for abdominal aortic aneurysmsOTHER

Duplex ultra sound screening for abdominal aortic aneurysms in Israeli Arab men, smokers or past smokers at the age of 60-80 years.

Israeli Arab men

Eligibility Criteria

Age60 Years - 80 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Arab men
  • Age : 60-80 years old
  • History of smoking

You may not qualify if:

  • A known AAA
  • Previous operations of the abdominal aorta
  • Previous imaging study within the last 12 months, ruling-out AAA.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clalit Health Services primary clinics

Haifa, Haifa and Western Galilee District & Northen District, Israel

Location

Related Publications (10)

  • Fleming C, Whitlock EP, Beil TL, Lederle FA. Screening for abdominal aortic aneurysm: a best-evidence systematic review for the U.S. Preventive Services Task Force. Ann Intern Med. 2005 Feb 1;142(3):203-11. doi: 10.7326/0003-4819-142-3-200502010-00012.

    PMID: 15684209BACKGROUND

  • Thompson SG, Ashton HA, Gao L, Buxton MJ, Scott RA; Multicentre Aneurysm Screening Study (MASS) Group. Final follow-up of the Multicentre Aneurysm Screening Study (MASS) randomized trial of abdominal aortic aneurysm screening. Br J Surg. 2012 Dec;99(12):1649-56. doi: 10.1002/bjs.8897. Epub 2012 Oct 3.

    PMID: 23034729BACKGROUND

  • U.S. Preventive Services Task Force. Screening for abdominal aortic aneurysm: recommendation statement. Ann Intern Med. 2005 Feb 1;142(3):198-202. doi: 10.7326/0003-4819-142-3-200502010-00011. No abstract available.

    PMID: 15684208BACKGROUND

  • Norman PE, Jamrozik K, Lawrence-Brown MM, Le MT, Spencer CA, Tuohy RJ, Parsons RW, Dickinson JA. Population based randomised controlled trial on impact of screening on mortality from abdominal aortic aneurysm. BMJ. 2004 Nov 27;329(7477):1259. doi: 10.1136/bmj.38272.478438.55. Epub 2004 Nov 15.

    PMID: 15545293BACKGROUND

  • Wilmink AB, Quick CR, Hubbard CS, Day NE. Effectiveness and cost of screening for abdominal aortic aneurysm: results of a population screening program. J Vasc Surg. 2003 Jul;38(1):72-7. doi: 10.1016/s0741-5214(03)00135-6.

    PMID: 12844092BACKGROUND

  • Vardulaki KA, Walker NM, Couto E, Day NE, Thompson SG, Ashton HA, Scott RA. Late results concerning feasibility and compliance from a randomized trial of ultrasonographic screening for abdominal aortic aneurysm. Br J Surg. 2002 Jul;89(7):861-4. doi: 10.1046/j.1365-2168.2002.02133.x.

    PMID: 12081734BACKGROUND

  • Ashton HA, Buxton MJ, Day NE, Kim LG, Marteau TM, Scott RA, Thompson SG, Walker NM; Multicentre Aneurysm Screening Study Group. The Multicentre Aneurysm Screening Study (MASS) into the effect of abdominal aortic aneurysm screening on mortality in men: a randomised controlled trial. Lancet. 2002 Nov 16;360(9345):1531-9. doi: 10.1016/s0140-6736(02)11522-4.

    PMID: 12443589BACKGROUND

  • Lindholt JS, Juul S, Henneberg EW. High-risk and low-risk screening for abdominal aortic aneurysm both reduce aneurysm-related mortality. A stratified analysis from a single-centre randomised screening trial. Eur J Vasc Endovasc Surg. 2007 Jul;34(1):53-8. doi: 10.1016/j.ejvs.2006.12.031. Epub 2007 Feb 28.

    PMID: 17331750BACKGROUND

  • Davis M, Harris M, Earnshaw JJ. Implementation of the National Health Service Abdominal Aortic Aneurysm Screening Program in England. J Vasc Surg. 2013 May;57(5):1440-5. doi: 10.1016/j.jvs.2012.10.114. Epub 2013 Mar 21.

    PMID: 23523277BACKGROUND

  • Baron-Epel O, Keinan-Boker L, Weinstein R, Shohat T. Persistent high rates of smoking among Israeli Arab males with concomitant decrease among Jews. Isr Med Assoc J. 2010 Dec;12(12):732-7.

    PMID: 21348400BACKGROUND

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic AneurysmAneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Study Officials

  • Asaf Rabin, M.D.

    Clalit Heath Services

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

November 26, 2014

First Posted

December 3, 2014

Study Start

January 1, 2015

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

February 9, 2017

Record last verified: 2017-02

Locations

IL(1)