Bahaviour at the time of an aortic aneurysm rupture in Aortic Aneurysm - Clinical Trials Registry

Study Overview

Status

Recruiting

Conditions

Aortic Aneurysm

Intervention / Treatment

Behavioral: Bahaviour at the time of an aortic aneurysm rupture

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Tobias Warm, MD
Phone Number: +49821400161068
Email: tobias.warm@uk-augsburg.de

Study Contact Backup

Name: Yvonne Gosslau, MD
Phone Number: +49821400161977
Email: yvonne.gosslau@uk-augsburg.de

Study Locations

Germany
- - Augsburg, Germany, 86156
    - Recruiting
    - University Hospital Augsburg
    - Contact:
      
      Tobias Warm, MD
      
      Phone Number: +49821400161068
      
      Email: tobias.warm@uk-augsburg.de

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients with ruptured aortic aneurysm in Augsburg University Hospital form 01/01/24 till 12/31/29 for the prospecitve part of the trial.

All patients who have been treated for a ruptured aortic aneurysm in Augsburg University Hospital form 01/01/13 till 12/31/23 for the retrospectitve part of the trial.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occupation at the time of the aortic aneurysm rupture Time Frame: Occupation at the day of the aortic rupture and the three days prior	Occupation at the time of the aortic aneurysm rupture	Occupation at the day of the aortic rupture and the three days prior

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Augsburg

Collaborators

Epidemiology, Medical Faculty, University Augsburg

Investigators

Study Chair: Alexander Hyhlik-Duerr, Prof., University Hospital Augsburg Vascular Surgery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

December 1, 2030

Study Registration Dates

First Submitted

January 29, 2024

First Submitted That Met QC Criteria

April 11, 2024

First Posted (Estimated)

April 15, 2024

Study Record Updates

Last Update Posted (Estimated)