Ultra-sound for AAA Screening in Smoking Israeli Arab Men

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Brief Title

Ultra-sound for AAA Screening in Smoking Israeli Arab Men

Official Title

Ultra-sound for AAA Screening in Smoking Israeli Arab Men

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.
    

Detailed Description

      Study Protocol No.:0017-14-COM

      Ultra-sound for AAA screening in smoking Israeli Arab men

      Initiator & Head researcher:

      Asaf Rabin, M.D. Vascular Clinic, Haifa and Western Galilee district, Clalit Health Services
      Horev Center, Haifa [email protected]

      +972-527-950-905

      Signature:

      Contents

        1. Study Rationale & References --------------------------- 4-5

        2. Goals ----------------------------------------------------------- 6

        3. Research Design ---------------------------------------------- 7

        4. Inclusion and exclusion criteria ----------------------------- 8

        5. CRF---------------------------------------------------------- 9-10

        6. End Points & Follow up chart -------------------------- 11-12

        7. Confidentiality ------------------------------------------------ 13

      Study Rationale

      In the United States ruptured abdominal aortic aneurysms (AAA) are the 15th leading cause of
      death overall and the 10th leading cause of death in men older than 55 years. The prevalence
      of AAA found in population-based ultrasonography (US) screening studies from various
      countries is about 4-9% in men and 1% in women older than 65yr.

      If left untreated, the aneurysm continues to expand; thinning of the aortic wall ensues and
      rupture may eventually occur. Most of large AAA are asymptomatic and often rupture occurs
      with no warning signs.

      Mortality due to rupture of an aortic aneurysm is high (80-90%), compared to 5-7% in elective
      surgery for AAA repair and even lower when treated by endovascular means (1-2%).

      Ultra-sound can reliably demonstrate the aorta in 99% of the population, and its sensitivity
      and specificity in diagnosing AAA approaches 95-100%. Screening with Ultra-sound for AAA has
      been proved in multiple studies to reduce AAA related mortality by an average of 42% in the
      screened population compared with the non-screened population. The reduction in mortality was
      achieved in a cost effective way. Based on such studies a number of screening programs have
      been implemented in the United Kingdom (UK), United States (USA), Scotland and Sweden.

      As for today there is no screening program for AAA in Israel. The investigators would like to
      conduct a study in a specific group of the population demonstrating the need for screening in
      such group.

      The major risk factors for AAA include Age (>65 years), male gender and a history of ever
      smoking. It has been demonstrated that smoking rates among Israeli Arab men are significantly
      higher than those of Israeli Jewish men. Most of the Israeli Arab population inhabits rural
      areas with less access to hospitals and medical centers.

      Therefore, the investigators decided to conduct a prospective study in which Israeli Arab men
      between the ages 60-80 years old, with a history of smoking, will undergo an ultra-sound
      examination for screening for AAA.

      Goals The investigators aim at revealing the actual prevalence of AAA in the Israeli Arab
      smoking men population. By revealing this prevalence the investigators 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. Performing the screening ultra-sound
      in the family-physician's clinics (see below under "Research Design") will save the patients
      the time and the trouble involved with being examined in the central vascular clinics. It
      will also improve the knowledge and awareness of the population in general and of the
      family-physicians in particular of the AAA disease and for the need of early diagnosis and
      treatment as mentioned above.

      Last but not least, the private benefit of each patient either from ruling out the option of
      having an AAA or from diagnosis of an AAA and referral to treatment is a valuable by-product
      of the research.

      Research Design 2000 men (according to the inclusion criteria) are planned to be included in
      the "screening study" over a period of one year to two years.

      The family-physicians of the Haifa and Western Galilee district, Clalit Health Services will
      be notified by the head researcher about the research. The organization will be asked to
      provide a list of potential patients according to the inclusion and exclusion criteria. The
      list will only include patients whom the physician had addressed and whom had given their
      approval for being approached by the research team.

      The patients will then be invited for a meeting with one of the researchers at the
      family-physician clinic. After a full explanation will be given, an informed consent form
      will be signed by the patient. Each patient will be documented on a Case Report Form (CRF)
      and will be given a code for the rest of the research. The coding system is aimed at securing
      the confidentiality of the patients' personal and medical information.

      Then after, with the help of the technician a Duplex Ultra-sound examination of the abdominal
      aorta will be performed. Since the examination is performed after a 6 hours fasting period,
      the fasting instruction will be given to the patients in advance. The results of the scans
      will be recorded in each patient Case Report Form (CRF).

      The patient will be classified according to the Duplex US findings into one of 4 sub-groups
      as detailed under "End-Points". A recommendation for further follow-up or treatment will be
      given to each patient and will be documented in his CRF accordingly. The results of the scan
      and the recommendations will be sent the patient and to his family-physician within a short
      period following the exam.

      It is to be made clear both hereby and in the informed consent form that the consent of the
      patient to participate in the research bares no further obligations to follow the
      recommendations of the research team nor to be followed-up or treated under the umbrella of
      the vascular service of Haifa and Western Galilee district, Clalit Health Services.

      Non-the-less, each of the patients is entitled for full follow-up and treatment by the
      vascular service of Haifa and Western Galilee district, Clalit Health Services regardless of
      his consent to participate in the research or to follow the research team recommendations.

      Each patient will be documented digitally in a separate research file. A copy of the informed
      consent will be given to patient. The same document will be scanned and filed in the patients
      research file. The file will also contain the CRF and the exam results.

      Study name: US for AAA screening in smoking Israeli Arab men

      Patient code:

      Date:

      Place:

      Case Report Form (CRF) Form filled at enrollment

        1. Age (60-80):

        2. Smoking:

             1. Active / in Past / No

             2. Y.P. -

        3. Israeli Arab man: Yes / No

        4. A known AAA

        5. Previous operations of the abdominal aorta

        6. Previous imaging study within the last 12 months, ruling-out AAA.

        7. Match to inclusion criteria: Yes / No

           ---------------------------------------------------------------------------------

        8. Weight:

        9. Height:

       10. Hypertension: Yes / No

       11. Diabetes mellitus: Yes / No

       12. Hypercholesterolemia/hyperlipidemia: Yes/ No

       13. Ischemic heart disease:

             1. Myocardial infarction- Yes/ No

             2. Coronary artery bypass- Yes/ No

             3. Catheterization - Yes/ No

       14. Origin of medical information:

             1. The patient - Yes / No

             2. The patient's relatives - Yes / No

             3. The patient's general physician - Yes / No

             4. Computerized medical file - Yes / No

             5. Other medical documents - Yes / No

       15. Ultra-sound results:

             1. Abdominal aorta maximal diameter- _____ cm

             2. Sub-group - A / B / C / D

      Date: ________ Physician name & signature:__________

      End-Points & Follow up chart A formal report will be produced for every examination and will
      be signed by a vascular surgeon and sent to the patient and to his family-physician.

      The examined patient will be classified into one of the listed sub-groups according to the
      measured maximal aortic diameter.

      The head researcher will be responsible for inviting the patient for further follow-up or for
      additional work-up and treatment according to the findings.

      Result of screening US:

        -  Sub-group A:

             -  Normal Aorta (<3 cm)

             -  No need for follow up or extra imaging

        -  Sub-group B:

             -  Aortic Diameter ( 3-4.5 cm)

             -  Needs follow up: Annual aortic US

        -  Sub-group C:

             -  Aortic Diameter ( 4.5-5.5 cm)

             -  Needs follow up: Semiannual aortic US

        -  Sub-group D:

             -  Aortic Diameter (> 5.5cm)

             -  Further investigation and treatment: referral to Vascular Surgeon for treatment.

      Confidentiality

      The head researcher is committed for the confidentiality of the personal and medical
      information of the patient participating in the research.

      All the research documents will be coded and will contain no personal data. If personal
      details will be needed for the research they would be coded through a scrambling system for
      prevention of any identifying potential.

      The research data will be saved on a stand-alone computer and raw data will not be
      transferred or shared via internet.

      Clalit Health Services will be notified by the head-researcher for any occasion of data loss,
      theft or damage.

      The head-researcher will share the research raw data with any 3rd party only after a clear
      approval of Clalit Health Services is obtained.

      The research raw data will only be saved on a desk-top computer and not on any mobile
      electronic device.
    


Study Type

Interventional


Primary Outcome

Abdominal aortic aneurysm prevalence in the represented population


Condition

Abdominal Aortic Aneurysm (AAA)

Intervention

Duplex ultra sound screening for abdominal aortic aneurysms

Study Arms / Comparison Groups

 Israeli Arab men
Description:  Single arm study. The arm includes all enrolled patients screened by duplex ultra sound for abdominal aortic aneurysms.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

913

Start Date

January 2015

Completion Date

January 2017

Primary Completion Date

January 2017

Eligibility Criteria

        Inclusion Criteria:

          -  Arab men

          -  Age : 60-80 years old

          -  History of smoking

        Exclusion Criteria:

          -  A known AAA

          -  Previous operations of the abdominal aorta

          -  Previous imaging study within the last 12 months, ruling-out AAA.
      

Gender

Male

Ages

60 Years - 80 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Asaf Rabin, M.D., , 

Location Countries

Israel

Location Countries

Israel

Administrative Informations


NCT ID

NCT02306304

Organization ID

ClalitHS


Responsible Party

Principal Investigator

Study Sponsor

Clalit Health Services

Collaborators

 Medtronic

Study Sponsor

Asaf Rabin, M.D., Principal Investigator, Clalit Heath Services


Verification Date

February 2017