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A Laboratory Scan of Patients With Aortic Aneurysms to IgG4 Levels in the Blood

Primary Purpose

IgG4-related Disease, Aortic Aneurysm

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Blood Test
Sponsored by
Meir Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for IgG4-related Disease

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients after aneurysm in the aorta
  • Men and women aged 18-100 (not including special populations)
  • Those who are able to read understand and sign a written consent to participate in the research

Exclusion Criteria:

  • Any patient who does not meet the inclusion criteria

Sites / Locations

  • Yael Eizikovits

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

single arm

Arm Description

Patients after aneurysm in the aorta, Men and women aged 18-100 (not including special populations), who are able to read understand and sign a written consent to participate in the research

Outcomes

Primary Outcome Measures

IgG4 Level
count IgG4 Level to figure if its IgG4-related disease

Secondary Outcome Measures

Full Information

First Posted
August 29, 2017
Last Updated
November 8, 2017
Sponsor
Meir Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03267875
Brief Title
A Laboratory Scan of Patients With Aortic Aneurysms to IgG4 Levels in the Blood
Official Title
A Laboratory Scan of Patients With Aortic Aneurysms to IgG4 Levels in the Blood
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 8, 2017 (Anticipated)
Primary Completion Date
October 1, 2018 (Anticipated)
Study Completion Date
October 1, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Meir Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
IgG4 Related Disease is a multi-systemic fibroenophilic disease that includes a basket of recently discovered medical conditions. The properties that bind them are: lesions similar to tumors in the mixed organs, lymphoplasms filtrate enriched with plasma IgG4 positive cells, storiform fibrosis, and often, but not always, a high level of IgG4 in the serum. This disease has been on the rise for the past two decades and since its recognition in 2001 there has been impressive progress in understanding its various manifestations, so that today almost every body system can be involved. One of the conditions associated with this disease is oritis / periortitis and aneurysms
Detailed Description
IgG4 Related Disease is a multi-systemic fibroenophilic disease that includes a basket of recently discovered medical conditions. The properties that bind them are: lesions similar to tumors in the mixed organs, lymphoplasms filtrate enriched with plasma IgG4 positive cells, storiform fibrosis, and often, but not always, a high level of IgG4 in the serum. This disease has been on the rise for the past two decades and since its recognition in 2001 there has been impressive progress in understanding its various manifestations, so that today almost every body system can be involved. One of the conditions associated with this disease is oritis / periortitis and aneurysms It is common to divide the aortic aneurysms according to the following etiologies: Inflammatory-Aortic Aneurisms (IAA) The internal division in this category is whether IgG4RD is related / not related. Atherosclerotic infrastructure. Differences between the etiologies: IAA - greater thickness of the wall, fibrosis and adhesion to nearby retroperitone structures. Also, younger age and non-specific symptoms. In addition, the laboratory findings are usually white counts and increased CRP. In this context, the investigators will examine the level of IgG4 in the blood of a population of patients with aortic aneurysms and try to understand the proportion of patients whose IgG4 level is higher than normal and their aneurysm can be attributed to IgG4 Related Disease. the investigator chose the blood IgG4 level because it is the most important diagnostic variable for the disease (it is customary to place the incision point at > 135mg / dL).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IgG4-related Disease, Aortic Aneurysm

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
single arm
Arm Type
Experimental
Arm Description
Patients after aneurysm in the aorta, Men and women aged 18-100 (not including special populations), who are able to read understand and sign a written consent to participate in the research
Intervention Type
Procedure
Intervention Name(s)
Blood Test
Intervention Description
draw out 2 blood tubes from a patient
Primary Outcome Measure Information:
Title
IgG4 Level
Description
count IgG4 Level to figure if its IgG4-related disease
Time Frame
1 year

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
male and female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients after aneurysm in the aorta Men and women aged 18-100 (not including special populations) Those who are able to read understand and sign a written consent to participate in the research Exclusion Criteria: Any patient who does not meet the inclusion criteria
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eran Levi, EMT-P
Phone
+972-9-7471936
Email
eran.levi@clalit.org.il
First Name & Middle Initial & Last Name or Official Title & Degree
Yfat Buhbut, B.sc
Phone
+972-9-7471936
Email
yfat.buhbut@clalit.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yael Eizikovits, B.A
Organizational Affiliation
Meir Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Yael Eizikovits
City
Kfar Saba
ZIP/Postal Code
44281
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

A Laboratory Scan of Patients With Aortic Aneurysms to IgG4 Levels in the Blood

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