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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03267875
Other study ID # Aneurysm-IgG4
Secondary ID
Status Not yet recruiting
Phase N/A
First received August 29, 2017
Last updated November 8, 2017
Start date November 8, 2017
Est. completion date October 1, 2018

Study information

Verified date August 2017
Source Meir Medical Center
Contact Eran Levi, EMT-P
Phone +972-9-7471936
Email eran.levi@clalit.org.il
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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).


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 300
Est. completion date October 1, 2018
Est. primary completion date October 1, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Blood Test
draw out 2 blood tubes from a patient

Locations

Country Name City State
Israel Yael Eizikovits Kfar Saba

Sponsors (1)

Lead Sponsor Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary IgG4 Level count IgG4 Level to figure if its IgG4-related disease 1 year
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