Clinical trial NCT03267875: 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
Overall status: UNKNOWN
Phase: NA
Conditions: IgG4-related Disease
Aortic Aneurysm
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2017-08-30
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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:

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).

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

Primary outcomes:
measure: IgG4 Level
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Yael Eizikovits
Study officials:
affiliation: Meir Medical Center
name: Yael Eizikovits, B.A
role: STUDY_CHAIR
References: