Aortic AneurysmNCT06365138
Analysis of Individual Activity at the Time of Aortic Rupture in Patients With Abdominal Aortic Aneurysms
An observational study of Aortic Aneurysm, run by University Hospital Augsburg at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Aneurysm
- What is being tested?
- Bahaviour at the time of an aortic aneurysm rupture
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 500 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2024to 1 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Lack of consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Augsburg
Augsburg, 86156
Tobias Warm, MD, +49821400161068, tobias.warm@uk-augsburg.de
About this study
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.
Read the 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.
- Conditions
- Aortic Aneurysm
- Being tested
- Bahaviour at the time of an aortic aneurysm rupture
- Keywords
- Aortic Rupture, Physical stress, Emotional Stress, Rupture Risc, Follow-Up, Activity
- Medical subject headings
- Aortic Aneurysm, Aortic Rupture, Stress, Psychological, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bahaviour at the time of an aortic aneurysm ruptureBehavioural
Questionnaire and patient interview, diary for day of rupture and the three previous days
What is being measured
The primary outcome is the main question the study is designed to answer.
Occupation at the time of the aortic aneurysm rupture
Occupation at the time of the aortic aneurysm rupture
Measured: Occupation at the day of the aortic rupture and the three days prior
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study start1 Jan 2024
- Primary completion1 Dec 2029 (estimated)
- Study completion1 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Augsburg
- Sponsor type
- University, hospital or other
- Collaborators
- Epidemiology, Medical Faculty, University Augsburg
- Responsible party
- Sponsor
- Investigators
- Alexander Hyhlik-Duerr, Prof., Study chair, University Hospital Augsburg Vascular Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06365138
- Sponsor's protocol ID
- Aortic Rupture
- Status last verified
- Apr 2024
- First submitted
- 29 Jan 2024
- Last updated
- 15 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Individual Activity at the Time of Aortic Rupture in Patients With Abdominal Aortic Aneurysms
- ClinicalTrials.gov ID
- NCT06365138
- Acronym / sponsor ID
- Aortic Rupture
- Conditions
- Aortic Aneurysm
- Keywords
- Aortic Rupture, Physical stress, Emotional Stress, Rupture Risc, Follow-Up, Activity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University Hospital AugsburgUniversity, hospital or other
- Collaborators
- Epidemiology, Medical Faculty, University Augsburg
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Dec 2029 (estimated)
- Study completion
- 1 Dec 2030 (estimated)
- First posted
- 15 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Lack of consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bahaviour at the time of an aortic aneurysm ruptureQuestionnaire and patient interview, diary for day of rupture and the three previous days | Behavioural | – |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alexander Hyhlik-Duerr, Prof. study chair
University Hospital Augsburg Vascular Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Aneurysm, run by University Hospital Augsburg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tobias Warm, MD (+49821400161068, tobias.warm@uk-augsburg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occupation at the time of the aortic aneurysm rupture (time frame: Occupation at the day of the aortic rupture and the three days prior). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2024.