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

Aortic Aneurysm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03267875
• Other study ID #: Aneurysm-IgG4
• 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
• 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

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• IgG4-related Disease

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