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

NCT ID: NCT03267875

Last Updated: 2017-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-08

Study Completion Date

2018-10-01

Brief Summary

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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

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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:

1. Inflammatory-Aortic Aneurisms (IAA) The internal division in this category is whether IgG4RD is related / not related.
2. 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).

Conditions

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IgG4-related Disease Aortic Aneurysm

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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single arm

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

Group Type EXPERIMENTAL

Blood Test

Intervention Type PROCEDURE

draw out 2 blood tubes from a patient

Interventions

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Blood Test

draw out 2 blood tubes from a patient

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Meir Medical Center

OTHER

Sponsor Role lead

Responsible Party

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yair levy

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yael Eizikovits, B.A

Role: STUDY_CHAIR

Meir Medical Center

Locations

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Yael Eizikovits

Kfar Saba, , Israel

Site Status

Countries

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Israel

Central Contacts

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Eran Levi, EMT-P

Role: CONTACT

Phone: +972-9-7471936

Email: [email protected]

Yfat Buhbut, B.sc

Role: CONTACT

Phone: +972-9-7471936

Email: [email protected]

Other Identifiers

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Aneurysm-IgG4

Identifier Type: -

Identifier Source: org_study_id