Ignite Creation Date:
2024-05-06 @ 3:29 AM
Last Modification Date:
2024-10-26 @ 11:34 AM
Study NCT ID:
NCT02306304
Status:
COMPLETED
Last Update Posted:
2017-02-09
First Post:
2014-11-26
Brief Title:
Ultra-sound for AAA Screening in Smoking Israeli Arab Men
Sponsor:
Clalit Health Services
Organization:
Clalit Health Services
Study Overview
Official Title:
Ultra-sound for AAA Screening in Smoking Israeli Arab Men
Status:
COMPLETED
Status Verified Date:
2017-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 No0017-14-COM
Ultra-sound for AAA screening in smoking Israeli Arab men
Initiator Head researcher
Asaf Rabin MD Vascular Clinic Haifa and Western Galilee district Clalit Health Services Horev Center Haifa asafrabingmailcom
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-physicians 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 YP -
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 Hypercholesterolemiahyperlipidemia 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 patients relatives - Yes No
3 The patients 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 3-45 cm
Needs follow up Annual aortic US
Sub-group C
Aortic Diameter 45-55 cm
Needs follow up Semiannual aortic US
Sub-group D
Aortic Diameter 55cm
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
Ultra-sound for AAA screening in smoking Israeli Arab men
Initiator Head researcher
Asaf Rabin MD Vascular Clinic Haifa and Western Galilee district Clalit Health Services Horev Center Haifa asafrabingmailcom
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-physicians 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 YP -
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 Hypercholesterolemiahyperlipidemia 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 patients relatives - Yes No
3 The patients 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 3-45 cm
Needs follow up Annual aortic US
Sub-group C
Aortic Diameter 45-55 cm
Needs follow up Semiannual aortic US
Sub-group D
Aortic Diameter 55cm
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None