Analysis of Individual Activity at the Time of Aortic Rupture in Patients With Abdominal Aortic Aneurysms

Aortic Aneurysm Clinical Trial

Official title:

Analysis of Individual Activity at the Time of Aortic Rupture in Patients With Abdominal Aortic Aneurysms

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06365138
• Other study ID #: Aortic Rupture
• Status: Recruiting
• Start date: January 1, 2024
• Est. completion date: December 1, 2030

Study information

• Verified date: April 2024
• Source: University Hospital Augsburg
• Contact: Tobias Warm, MD
• Phone: +49821400161068
• Email: tobias.warm[@]uk-augsburg.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

It is currently unclear what activities aneurysms are involved in at the time of rupture. The aim of the study is to determine the activity performed at the time of aneurysm rupture.

Description:

The scientifically proven risk factors that significantly favor the rupture of an aortic aneurysm are female gender, the maximum diameter of the aortic aneurysm and the patient's current smoking status.

However, no analysis of the occupation performed at the time of aortic rupture of an abdominal aortic aneurysm has yet been carried out.

High arterial systolic blood pressure can promote aortic rupture. Blood pressure peaks can occur during physical exertion, for example when lifting heavy loads or during defecation.

Patients with an existing intact aortic aneurysm are currently advised to avoid such behaviors as a preventive measure. This includes, among other things, the practice of strength training or certain types of sport. This can subsequently lead to a reduction in quality of life, although this cannot currently be substantiated by scientific data. There is also no current guideline recommendation in this regard.

Furthermore, the role of stress and / or emotionally stressful events in connection with the occurrence of aortic ruptures has not yet been recorded in the literature. There is work on this in connection with aortic dissections, which postulates that an increase in emotional or psychological stress can lead to acute hypertension, which can cause a previously damaged aorta to rupture. A similar pathomechanism would also be conceivable for the rupture of aortic aneurysms.

There are indications that, in addition to gender-specific differences in the occurrence of aortic ruptures, there is also a different risk of rupture based on certain pre-existing conditions, dietary habits and age.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 1, 2030
• Est. primary completion date: December 1, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• inclusion of all patients with ruptured aortic aneurysm in Augsburg University Hospital

• Written consent to participate in the study by the patient or their legal representative

Exclusion Criteria:

• Lack of consent

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal
• Aortic Rupture
• Rupture

Intervention

Behavioral:
• Bahaviour at the time of an aortic aneurysm rupture
Questionnaire and patient interview, diary for day of rupture and the three previous days

Locations

Country	Name	City	State
Germany	University Hospital Augsburg	Augsburg

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Augsburg	Epidemiology, Medical Faculty, University Augsburg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occupation at the time of the aortic aneurysm rupture	Occupation at the time of the aortic aneurysm rupture	Occupation at the day of the aortic rupture and the three days prior