NCT06365138

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
55mo left

Started Jan 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress34%
Jan 2024Dec 2030

Study Start

First participant enrolled

January 1, 2024

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

January 29, 2024

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 15, 2024

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2029

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2030

Last Updated

April 15, 2024

Status Verified

April 1, 2024

Enrollment Period

5.9 years

First QC Date

January 29, 2024

Last Update Submit

April 11, 2024

Conditions

Aortic Aneurysm

Keywords

Aortic RupturePhysical stressEmotional StressRupture RiscFollow-UpActivity

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

Bahaviour at the time of an aortic aneurysm ruptureBEHAVIORAL

Questionnaire and patient interview, diary for day of rupture and the three previous days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • Lack of consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Augsburg

Augsburg, 86156, Germany

RECRUITING

MeSH Terms

Conditions

Aortic AneurysmAortic RuptureStress, PsychologicalMotor Activity

Condition Hierarchy (Ancestors)

AneurysmVascular DiseasesCardiovascular DiseasesAortic DiseasesAneurysm, RupturedRuptureWounds and InjuriesBehavioral SymptomsBehavior

Study Officials

  • Alexander Hyhlik-Duerr, Prof.

    University Hospital Augsburg Vascular Surgery

    STUDY CHAIR

Central Study Contacts

Tobias Warm, MD

CONTACT

+49821400161068tobias.warm@uk-augsburg.de

Yvonne Gosslau, MD

CONTACT

+49821400161977yvonne.gosslau@uk-augsburg.de

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2024

First Posted

April 15, 2024

Study Start

January 1, 2024

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

December 1, 2030

Last Updated

April 15, 2024

Record last verified: 2024-04

Locations

DE(1)