Acute Aortic DissectionNCT06353607
Genetic Architecture of Acute Aortic Syndromes and Aortic Aneurysm.
An observational study of Acute Aortic Dissection and Thoracic Aortic Aneurysm, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
The aim of this study is to explore the genetic information associated with the development of TAA and aAD in individuals without history or syndromic features (Marfan syndrome, Ehlers-Danlos syndrome, Turner syndrome etc.) for aortic disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Aortic Dissection, Thoracic Aortic Aneurysm
- How many people
- 730 participants
- Where
- 1 siteSwitzerland
- Study dates
- 8 Apr 2024to 31 Dec 2028
- 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: Patients with surgical aAD or TAA intervention performed at the Unversity Hospital Basel between 2015 and 2028.
Who may be able to join
- All adult patients > 18 years who underwent surgery for aAD or TAA intervention at the University Hospital Basel, starting in 2015.
- All patients who will undergo surgery for aAD or TAA at the University Hospital Basel, beginning in 2024.
Who cannot join
- Patients will be excluded if they are not able or not willing to provide informed consent.
- Patients with diagnosed heritable vascular disorders, such as Marfan syndrome, Turner Syndrome, Loeyes Dietz and Ehlers-Danlos syndrome.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Basel
Basel, 4031
Denis Berdajs, Prof. Dr., 0041 61 328 71 80, denis.berdajs@usb.ch
Islam Salikhanov, Dr., 0041 61 26 53225, islam.salikhanov@usb.ch
About this study
The aim of this study is to explore the genetic information associated with the development of TAA and aAD in individuals without history or syndromic features (Marfan syndrome, Ehlers-Danlos syndrome, Turner syndrome etc.) for aortic disease. For this purpose, whole genome sequencing will be performed in patients with documented aortic aneurysm or/and aortic dissection.
Read the detailed description
Acute aortic dissection (aAD) is a life-threatening condition, associated with increased morbidity and mortality. The incidence of aAD has been estimated to occur at a rate of 6-7 cases per 100.000 persons per year and is associated with high mortality. With the increasing availability of computed tomography scan (CT) in emergency settings, the diagnosis of aAD was increasing in past decades, increasing up to 17 cases per 100.000 persons per year. Acute aortic event is associated with a high mortality rate ranging from 26% in surgically treated patients to 58% in medically treated patients.
Thoracic aortic aneurysm (TAA) is a well-established risk factor for aAD but it is not a prerequisite. Recent evidence suggests that almost 90% of aAD's occur mostly in younger patients with aortic dimensions of <5.5 cm and only 5% of patients with diagnosed TAA are symptomatic prior to dissection or rupture.
The majority of aAD patients are misdiagnosed, which puts them at a higher risk of death. Timely diagnosis and surgical management of patients with TAA prior to aAD reduces the risk of complications and death. Therefore, there is an unmet need for better and more refined risk prediction tools to identify high-risk patients with TAA, who may benefit from early screening and tuned surgical intervention.
Previous studies found that more than 20% of patients with TAA report a positive family history, and the genetics of thoracic aortic aneurysm and dissection has been extensively investigated as a potential tool for both diagnosis and risk stratification.
Traditionally, TAA is divided into syndromic-with other organ system abnormalities other than the aorta-and non-syndromic-with no systemic abnormalities present. Several monogenic causes for syndromic TAA are well described, such as Marfan syndrome (MFS), Loeys-Dietz syndrome (LDS), and Ehlers-Danlos syndrome (EDS). However, the non-syndromic TAA and aAD are more prevalent, and identifying these patients can be challenging. Some evidence exist that mutations of genes observed in syndromic patients may be involved in TAA and aAD in non-syndromic patients. The fact that approximately 20% of non-syndromic TAA patients have at least one affected family member indicates that TAA could be a heritable disease and there might be a genetic link in non-syndromic patients.
Given the inherent challenges in the diagnosis of the TAA as a precursor of aAD in non-syndromic patients, there is a clinical need for the development of an accurate risk prediction tools. To address the mentioned clinically relevant question, in an observational cohort study of patients with aortic disease a molecular genetic investigation will be conducted to investigate the genetic architecture of TAA and individuals at high risk for aAD, and to use this information to propose patient specific risk assessment and individually tailored management and therapy. This data will be coupled to the routinely collected standard clinical and imaging data including computed tomography angiography (CTA), perioperative transesophageal echocardiogram (TEE) and transthoracic echocardiogram (TTE) with the aim to further refine risk stratification in aAD/TAA patients.
- Conditions
- Acute Aortic Dissection, Thoracic Aortic Aneurysm
- Medical subject headings
- Aortic Aneurysm, Thoracic
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the association between the prevalence of TAA and/or aAD in variants with genes associated with thoracic aortic disease.
Assessment of the association between the prevalence of TAA and/or aAD in variants with genes associated with thoracic aortic disease.
Measured: Baseline to last follow-up visit (up to 4 years)
Secondary outcomes (3)
Investigate the genetic landscape of aortic specimens retrieved from surgical intervention tissues, and relate the genetic profile to cell molecular pathology.
Investigate the genetic landscape of aortic specimens retrieved from surgical intervention tissues, and relate the genetic profile to cell molecular pathology.
Measured: Baseline to last follow-up visit (up to 4 years)
To assess the association between the aortic segment dimension (in CT scan and TEE images), tissue pathology and gene variants to determine the images predictive factors for TAA and/or aAD.
To assess the association between the aortic segment dimension (in CT scan and TEE images), tissue pathology and gene variants to determine the images predictive factors for TAA and/or aAD.
Measured: Baseline to last follow-up visit (up to 4 years)
To establish a risk prediction model for aAD and TAA based on genetic, clinical, and imaging endpoints.
To establish a risk prediction model for aAD and TAA based on genetic, clinical, and imaging endpoints.
Measured: Baseline to last follow-up visit (up to 4 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start8 Apr 2024
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Aortic DissectionStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 730 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Denis Berdajs, Prof. Dr., Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06353607
- Sponsor's protocol ID
- 2023-02267; kt23Berdajs
- Other IDs
- 2023
- Status last verified
- May 2025
- First submitted
- 2 Apr 2024
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Architecture of Acute Aortic Syndromes and Aortic Aneurysm.
- ClinicalTrials.gov ID
- NCT06353607
- Acronym / sponsor ID
- 2023-02267; kt23Berdajs
- Conditions
- Acute Aortic Dissection, Thoracic Aortic Aneurysm
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 730 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 8 Apr 2024 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 9 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.
The aim of this study is to explore the genetic information associated with the development of TAA and aAD in individuals without history or syndromic features (Marfan syndrome, Ehlers-Danlos syndrome, Turner syndrome etc.) for aortic disease. For this purpose, whole genome sequencing will be performed in patients with documented aortic aneurysm or/and aortic dissection.
Detailed description
Acute aortic dissection (aAD) is a life-threatening condition, associated with increased morbidity and mortality. The incidence of aAD has been estimated to occur at a rate of 6-7 cases per 100.000 persons per year and is associated with high mortality. With the increasing availability of computed tomography scan (CT) in emergency settings, the diagnosis of aAD was increasing in past decades, increasing up to 17 cases per 100.000 persons per year. Acute aortic event is associated with a high mortality rate ranging from 26% in surgically treated patients to 58% in medically treated patients.
Thoracic aortic aneurysm (TAA) is a well-established risk factor for aAD but it is not a prerequisite. Recent evidence suggests that almost 90% of aAD's occur mostly in younger patients with aortic dimensions of <5.5 cm and only 5% of patients with diagnosed TAA are symptomatic prior to dissection or rupture.
The majority of aAD patients are misdiagnosed, which puts them at a higher risk of death. Timely diagnosis and surgical management of patients with TAA prior to aAD reduces the risk of complications and death. Therefore, there is an unmet need for better and more refined risk prediction tools to identify high-risk patients with TAA, who may benefit from early screening and tuned surgical intervention.
Previous studies found that more than 20% of patients with TAA report a positive family history, and the genetics of thoracic aortic aneurysm and dissection has been extensively investigated as a potential tool for both diagnosis and risk stratification.
Traditionally, TAA is divided into syndromic-with other organ system abnormalities other than the aorta-and non-syndromic-with no systemic abnormalities present. Several monogenic causes for syndromic TAA are well described, such as Marfan syndrome (MFS), Loeys-Dietz syndrome (LDS), and Ehlers-Danlos syndrome (EDS). However, the non-syndromic TAA and aAD are more prevalent, and identifying these patients can be challenging. Some evidence exist that mutations of genes observed in syndromic patients may be involved in TAA and aAD in non-syndromic patients. The fact that approximately 20% of non-syndromic TAA patients have at least one affected family member indicates that TAA could be a heritable disease and there might be a genetic link in non-syndromic patients.
Given the inherent challenges in the diagnosis of the TAA as a precursor of aAD in non-syndromic patients, there is a clinical need for the development of an accurate risk prediction tools. To address the mentioned clinically relevant question, in an observational cohort study of patients with aortic disease a molecular genetic investigation will be conducted to investigate the genetic architecture of TAA and individuals at high risk for aAD, and to use this information to propose patient specific risk assessment and individually tailored management and therapy. This data will be coupled to the routinely collected standard clinical and imaging data including computed tomography angiography (CTA), perioperative transesophageal echocardiogram (TEE) and transthoracic echocardiogram (TTE) with the aim to further refine risk stratification in aAD/TAA patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with surgical aAD or TAA intervention performed at the Unversity Hospital Basel between 2015 and 2028.
Key inclusion criteria (2 listed)
- All adult patients > 18 years who underwent surgery for aAD or TAA intervention at the University Hospital Basel, starting in 2015.
- All patients who will undergo surgery for aAD or TAA at the University Hospital Basel, beginning in 2024.
Key exclusion criteria (2 listed)
- Patients will be excluded if they are not able or not willing to provide informed consent.
- Patients with diagnosed heritable vascular disorders, such as Marfan syndrome, Turner Syndrome, Loeyes Dietz and Ehlers-Danlos syndrome.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assessment of the association between the prevalence of TAA and/or aAD in variants with genes associated with thoracic aortic disease.
Time frame: Baseline to last follow-up visit (up to 4 years)
Assessment of the association between the prevalence of TAA and/or aAD in variants with genes associated with thoracic aortic disease.
3 secondary outcomes
Investigate the genetic landscape of aortic specimens retrieved from surgical intervention tissues, and relate the genetic profile to cell molecular pathology.
Time frame: Baseline to last follow-up visit (up to 4 years)
To assess the association between the aortic segment dimension (in CT scan and TEE images), tissue pathology and gene variants to determine the images predictive factors for TAA and/or aAD.
Time frame: Baseline to last follow-up visit (up to 4 years)
To establish a risk prediction model for aAD and TAA based on genetic, clinical, and imaging endpoints.
Time frame: Baseline to last follow-up visit (up to 4 years)
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 16 May 2025.
- Individual participant dataSharing planned: Undecided
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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.
Denis Berdajs, Prof. Dr. principal investigator
University Hospital, Basel, Switzerland
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 Acute Aortic Dissection and Thoracic Aortic Aneurysm, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 2 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 16 May 2025. 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 Switzerland. 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 Denis Berdajs, Prof. Dr. (0041 61 328 71 80, denis.berdajs@usb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the association between the prevalence of TAA and/or aAD in variants with genes associated with thoracic aortic disease. (time frame: Baseline to last follow-up visit (up to 4 years)). 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 16 May 2025; AzTrials last refreshed its copy on 8 Nov 2026.