Aortic DiseasesNCT05389865
Proximal Aortopathy in Scotland - Epidemiology and Surgical Outcomes
An observational study of Aortic Diseases and Aortic Dissection, run by Golden Jubilee National Hospital at 1 site in United Kingdom.
Trial summary
The aorta is the principal arterial vessel arising from the left heart that transfers blood to the body. Certain genetic and familial disease processes are known to weaken the aortic wall resulting in dilation and potential rupture. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Diseases, Aortic Dissection, Aortic Aneurysm, Thoracic
- What is being tested?
- Surgery on the proximal aorta (aortic root +/- ascending aorta) and Patients diagnosed with thoracic aortopathy but not operated upon
- Type of treatment
- Surgery or procedure
- How many people
- 1,662 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Dec 2023to Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Adult, Older adult
Study population: 1. Surgical cohort (Observational cohort design)- Adult patients (18 years of age and above) who have had a surgical intervention on the proximal aorta in the three Scottish Cardiothoracic Surgery units based in Glasgow, Edinburgh, Aberdeen. 2. Non-surgical cohort (Cross-sectional design) - Adult patients (18 years of age and above) who have a diagnosis of proximal aortopathy, but have not had surgical intervention (non-surgical/un-intervened proximal aortopathy). This cohort will be obtained from three sources: 1. Scottish national radiological database based on specific imaging codes 2. Regional genetic/inherited cardiac conditions services 3. Public Health Scotland via specific diagnostic ICD-10 codes.
Who may be able to join
- all adults (>18 years of age) that underwent surgical intervention on the proximal aorta in Scotland between 2008 and 2021.
- all adult patients (>18 years of age) with a radiological, genetic or post-mortem diagnosis of thoracic aortic disease
Who cannot join
- Isolated surgery on the descending thoracic aorta
- Non-surgical cohort
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Investigation Into the Epidemiology and Surgical Intervention for Proximal Aortic Disease in Scotland
The aorta is the principal arterial vessel arising from the left heart that transfers blood to the body. Certain genetic and familial disease processes are known to weaken the aortic wall resulting in dilation and potential rupture. These aortic complications carry high mortality (>25%) and current management is orientated towards early detection and preventive treatment. Aortic dilation can also result in aortic valve dysfunction leading to heart failure. The estimated UK incidence of aortic disease per year is around 10 per 100,000 individuals, with 2000 people per year dying from aortic complications.
The 2017-2020 National Adult Cardiac Surgery Audit report identified the number of people receiving surgery for aortic dissection in Scotland is per population proportionately lower compared to England (4.6 per million per year in Scotland vs. 6.6 per million per year in England). The reasons for this are unclear but may relate to the prevalence of aortic disease or a large geographic distribution with compromised access to specialized centres.
Read more
Currently surgery is recommended when the aortic diameter exceeds a certain threshold. There are several types of effective surgical procedures, but there is still limited information on their long-term outcomes and the advantage of one procedure over another.
The aims of the project are firstly to determine the clinical outcomes of the surgical procedures that are currently employed in Scotland to treat proximal aortic disease and secondly to describe the prevalence and distribution of proximal aortic disease within the Scottish population. The project will be hosted by the Golden Jubilee Research Institute. Contemporary and retrospective data will be collected from all the Scottish Cardiothoracic Surgery units which are based in Glasgow, Edinburgh and Aberdeen.
This will be the first study to analyse surgical outcomes for ascending aortic disease in Scotland, and the first to describe the epidemiology of aortic disease within the population. It is anticipated that the results will guide current surgical practise, and provide data to inform national service provision for the management of proximal aortic disease.
Read the detailed description
The study has two principal aims:
- Determine the patient demographics, procedural types and related clinical outcomes in patients who underwent surgery of the proximal thoracic aorta in Scotland
- Describe the epidemiology of proximal aortopathy within the Scottish population, by determining the prevalence of disease, geographic distribution and patient demographics
This study will be the first to look at outcomes from a nation-wide cohort of patients following surgery of the thoracic aorta in the UK. The investigators anticipate that results from this study will inform future aortic practice and guide decisions on intervention timing and type.
Information on the prevalence and geographic distribution of aortic disease within Scotland will guide resource allocation and service configuration to allow equity in access to treatment. By raising awareness among the medical professionals and the wider community, the study should lead to improved recognition and better outcomes for patients with aortic disease.
Data will be recorded in a contemporary and retrospective manner for two patient cohorts:
- Surgical cohort - Adult patients who have had a surgical intervention on the proximal aorta in the three Scottish Cardiothoracic Surgery units based in Glasgow, Edinburgh, Aberdeen in the last 13 years (2008 - 2021).
- Non-surgical cohort - Adult patients who have a diagnosis of proximal aortopathy, but have not had surgery. This cohort will be obtained from three sources:
- Patients with a diagnosis of thoracic aortopathy identified via National Interim Clinical Imaging Procedure (NICIP) codes sourced from the Scottish Radiology Information System (RIS) and Picture Archive and Communication System (PACS) databases.
- Patients with a diagnosis of thoracic aortopathy identified from regional genetic services via the Network for Inherited Cardiac Conditions Scotland.
- Deceased patients diagnosed with proximal thoracic aortopathy or a complication thereof (aortic dissection, aortic rupture) registered at death certification and/or post mortem accessed from Public Health Scotland using ICD-10 codes.
The three data collection sites will be the Golden Jubilee National Hospital in Glasgow, the Edinburgh Royal Infirmary and Aberdeen Royal Infirmary.
The surgical cohort sample size is expected to be around 1300 patients. The non-surgical cohort is difficult to estimate, but around 500 cases yearly are expected to be identified. The research project will be hosted by the NHS Golden Jubilee Research Department.
The principal investigator (George Gradinariu) will undertake this research project as part of an postgraduate research programme (MD degree) at the University of Glasgow under the supervision of Professor Mark Danton (Congenital Cardiac Surgeon with interest in proximal aortic surgery), Professor Alex McConnachie Professor of Biostatistics, University of Glasgow) and Professor Faisal Ahmed (Samson Gemmell Chair of Child Health, University of Glasgow)
Statistical analysis will be overseen and supervised by Professor McConnachie. Descriptive statistics will be applied. Survival data will be analysed using Kaplan-Meier. Multivariable survival and logistic regression models will be used to identify variables predicting the risk of adverse outcomes. Predictive modelling to estimate the risk of adverse outcomes based on aortic root dimension will be assessed using ROC analysis. In comparing survival by procedures propensity matching will be used to minimize confounding. Analysis will be performed using R statistical analysis software (R Foundation for Statistical Computing, Vienna, Austria).
- Conditions
- Aortic Diseases, Aortic Dissection, Aortic Aneurysm, Thoracic, Aortic Ectasia, Aortic Valve Insufficiency, Bicuspid Aortic Valve
- Being tested
- Surgery on the proximal aorta (aortic root +/- ascending aorta), Patients diagnosed with thoracic aortopathy but not operated upon
- Keywords
- aortic surgery, aortic root, ascending aorta, surgical outcomes, thoracic aortopathy epidemiology
- Medical subject headings
- Aortic Diseases, Aortic Dissection, Aortic Aneurysm, Thoracic, Aortic Valve Insufficiency, Bicuspid Aortic Valve Disease, Marfan Syndrome, Ehlers-Danlos Syndrome, Loeys-Dietz Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery on the proximal aorta (aortic root +/- ascending aorta)Procedure or surgery
Surgery involving replacing, repairing or reinforcing the proximal aorta (root and ascending aorta)
Patients diagnosed with thoracic aortopathy but not operated uponOther
Radiological size criteria or Genetic mutations associated with aortopathies
| Study group | Role | What they receive |
|---|---|---|
| Surgical cohort | Adult patients (18 years of age and above) who have had a surgical intervention on the proximal aorta in the three Scottish Cardiothoracic Surgery units based in Glasgow, Edinburgh, Aberdeen. Receives: Procedure: Surgery on the proximal aorta (aortic root +/- ascending aorta) | |
| Non-surgical cohort | - Adult patients (18 years of age and above) who have a diagnosis of proximal aortopathy, but have not had surgical intervention (non-surgical/un-intervened proximal aortopathy). This cohort will be obtained from three sources:
1. Scottish national radiological database based on specific imaging codes
2. Regional genetic/inherited cardiac conditions services
3. Public Health Scotland via specific diagnostic ICD-10 codes. Receives: Other: Patients diagnosed with thoracic aortopathy but not operated upon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early survival following surgery of the proximal aorta
In-hospital or 30 days survival following surgery of the proximal aorta
Measured: In-hospital or 30 days (whichever is longer)
Late survival following surgery of the proximal aorta
Long-term survival following surgery of the proximal aorta
Measured: 5 years or latest available follow-up (whichever is longer)
Patient demographics and geographic distribution of thoracic aortopathy within the Scottish population
Identify the demographics (age, gender, relevant risk factors) and geographic distribution (area codes) of patients diagnosed with thoracic aortopathy within the Scottish population
Measured: Cross-sectional analysis (2011-2021)
Secondary outcomes (5)
Cardiovascular reintervention
Reinterventions (surgical/endovascular) related to the aortic implant or unoperated aorta Reintervention on Aortic valve (native or prosthesis)
Measured: 1 year or latest available follow-up (whichever is longer)
Specified adverse events following surgery
episodes of endocarditis, structural valve degeneration, thromboembolism, cerebral vascular accident, anticoagulant-related bleeding
Measured: 1 year or latest available follow-up (whichever is longer)
Left ventricular ejection fraction (LVEF) following surgery
Long-term left ventricular ejection fraction (>50% - good, 31-50% - moderate, 21-30% - poor, 20% or less -very poor) as measured by echocardiography or cardiac MRI after surgery
Measured: 1 year or latest available follow-up (whichever is longer)
Aortic valve mean gradient and degree of regurgitation following surgery
Long-term aortic valve function as assessed by mean gradient (mmHg) and degree of regurgitation (mild/moderate/severe) in operated patients assessed by echocardiography or cardiac MRI
Measured: 1 year or latest available follow-up (whichever is longer)
Genotypes and phenotypes prevalent in the Scottish population
Identify genotypes and phenotypes in the Scottish population and assess their prevalence
Measured: Previous 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study start18 Dec 2023
- Primary completionAug 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic DiseasesStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,662 participants (actual)
Sponsor and investigators
- Lead sponsor
- Golden Jubilee National Hospital
- Sponsor type
- Other government
- Collaborators
- Aberdeen Royal Infirmary, Royal Infirmary of Edinburgh, Network for Inherited Cardiac Conditions Scotland, University of Glasgow
- Responsible party
- Principal investigator, George Gradinariu, Golden Jubilee National Hospital
- Investigators
- George Gradinariu, MD, Principal investigator, Golden Jubilee National Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05389865
- Sponsor's protocol ID
- IRAS 309277
- Status last verified
- Jul 2024
- First submitted
- 6 May 2022
- Last updated
- 15 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To apply for further studies, beyond the current research, using the existing dataset, a research proposal submitted to the GJNH Research Department will be required. This will follow the established internal peer-review process established by the GJNH research department. If approved, a data request form will need to be submitted to the data custodian who will release the pseudo- anonymised data to the research applicant. If there is no request to extend the study then this data will be deleted.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation Into the Epidemiology and Surgical Intervention for Proximal Aortic Disease in Scotland
- ClinicalTrials.gov ID
- NCT05389865
- Acronym / sponsor ID
- IRAS 309277
- Conditions
- Aortic Diseases, Aortic Dissection, Aortic Aneurysm, Thoracic, Aortic Ectasia, Aortic Valve Insufficiency, Bicuspid Aortic Valve
- Keywords
- aortic surgery, aortic root, ascending aorta, surgical outcomes, thoracic aortopathy epidemiology
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,662 participants (actual)
- Lead sponsor
- Golden Jubilee National HospitalOther government
- Collaborators
- Aberdeen Royal Infirmary, Royal Infirmary of Edinburgh, Network for Inherited Cardiac Conditions Scotland, University of Glasgow
- Study start
- 18 Dec 2023 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 25 May 2022 (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 aorta is the principal arterial vessel arising from the left heart that transfers blood to the body. Certain genetic and familial disease processes are known to weaken the aortic wall resulting in dilation and potential rupture. These aortic complications carry high mortality (>25%) and current management is orientated towards early detection and preventive treatment. Aortic dilation can also result in aortic valve dysfunction leading to heart failure. The estimated UK incidence of aortic disease per year is around 10 per 100,000 individuals, with 2000 people per year dying from aortic complications.
The 2017-2020 National Adult Cardiac Surgery Audit report identified the number of people receiving surgery for aortic dissection in Scotland is per population proportionately lower compared to England (4.6 per million per year in Scotland vs. 6.6 per million per year in England). The reasons for this are unclear but may relate to the prevalence of aortic disease or a large geographic distribution with compromised access to specialized centres.
Currently surgery is recommended when the aortic diameter exceeds a certain threshold. There are several types of effective surgical procedures, but there is still limited information on their long-term outcomes and the advantage of one procedure over another.
The aims of the project are firstly to determine the clinical outcomes of the surgical procedures that are currently employed in Scotland to treat proximal aortic disease and secondly to describe the prevalence and distribution of proximal aortic disease within the Scottish population. The project will be hosted by the Golden Jubilee Research Institute. Contemporary and retrospective data will be collected from all the Scottish Cardiothoracic Surgery units which are based in Glasgow, Edinburgh and Aberdeen.
This will be the first study to analyse surgical outcomes for ascending aortic disease in Scotland, and the first to describe the epidemiology of aortic disease within the population. It is anticipated that the results will guide current surgical practise, and provide data to inform national service provision for the management of proximal aortic disease.
Detailed description
The study has two principal aims:
- Determine the patient demographics, procedural types and related clinical outcomes in patients who underwent surgery of the proximal thoracic aorta in Scotland
- Describe the epidemiology of proximal aortopathy within the Scottish population, by determining the prevalence of disease, geographic distribution and patient demographics
This study will be the first to look at outcomes from a nation-wide cohort of patients following surgery of the thoracic aorta in the UK. The investigators anticipate that results from this study will inform future aortic practice and guide decisions on intervention timing and type.
Information on the prevalence and geographic distribution of aortic disease within Scotland will guide resource allocation and service configuration to allow equity in access to treatment. By raising awareness among the medical professionals and the wider community, the study should lead to improved recognition and better outcomes for patients with aortic disease.
Data will be recorded in a contemporary and retrospective manner for two patient cohorts:
- Surgical cohort - Adult patients who have had a surgical intervention on the proximal aorta in the three Scottish Cardiothoracic Surgery units based in Glasgow, Edinburgh, Aberdeen in the last 13 years (2008 - 2021).
- Non-surgical cohort - Adult patients who have a diagnosis of proximal aortopathy, but have not had surgery. This cohort will be obtained from three sources:
- Patients with a diagnosis of thoracic aortopathy identified via National Interim Clinical Imaging Procedure (NICIP) codes sourced from the Scottish Radiology Information System (RIS) and Picture Archive and Communication System (PACS) databases.
- Patients with a diagnosis of thoracic aortopathy identified from regional genetic services via the Network for Inherited Cardiac Conditions Scotland.
- Deceased patients diagnosed with proximal thoracic aortopathy or a complication thereof (aortic dissection, aortic rupture) registered at death certification and/or post mortem accessed from Public Health Scotland using ICD-10 codes.
The three data collection sites will be the Golden Jubilee National Hospital in Glasgow, the Edinburgh Royal Infirmary and Aberdeen Royal Infirmary.
The surgical cohort sample size is expected to be around 1300 patients. The non-surgical cohort is difficult to estimate, but around 500 cases yearly are expected to be identified. The research project will be hosted by the NHS Golden Jubilee Research Department.
The principal investigator (George Gradinariu) will undertake this research project as part of an postgraduate research programme (MD degree) at the University of Glasgow under the supervision of Professor Mark Danton (Congenital Cardiac Surgeon with interest in proximal aortic surgery), Professor Alex McConnachie Professor of Biostatistics, University of Glasgow) and Professor Faisal Ahmed (Samson Gemmell Chair of Child Health, University of Glasgow)
Statistical analysis will be overseen and supervised by Professor McConnachie. Descriptive statistics will be applied. Survival data will be analysed using Kaplan-Meier. Multivariable survival and logistic regression models will be used to identify variables predicting the risk of adverse outcomes. Predictive modelling to estimate the risk of adverse outcomes based on aortic root dimension will be assessed using ROC analysis. In comparing survival by procedures propensity matching will be used to minimize confounding. Analysis will be performed using R statistical analysis software (R Foundation for Statistical Computing, Vienna, Austria).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical cohort | – | Procedure: Surgery on the proximal aorta (aortic root +/- ascending aorta)Adult patients (18 years of age and above) who have had a surgical intervention on the proximal aorta in the three Scottish Cardiothoracic Surgery units based in Glasgow, Edinburgh, Aberdeen. |
| Non-surgical cohort | – | Other: Patients diagnosed with thoracic aortopathy but not operated upon- Adult patients (18 years of age and above) who have a diagnosis of proximal aortopathy, but have not had surgical intervention (non-surgical/un-intervened proximal aortopathy). This cohort will be obtained from three sources: 1. Scottish national radiological database based on specific imaging codes 2. Regional genetic/inherited cardiac conditions services 3. Public Health Scotland via specific diagnostic ICD-10 codes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 1. Surgical cohort (Observational cohort design)- Adult patients (18 years of age and above) who have had a surgical intervention on the proximal aorta in the three Scottish Cardiothoracic Surgery units based in Glasgow, Edinburgh, Aberdeen. 2. Non-surgical cohort (Cross-sectional design) - Adult patients (18 years of age and above) who have a diagnosis of proximal aortopathy, but have not had surgical intervention (non-surgical/un-intervened proximal aortopathy). This cohort will be obtained from three sources: 1. Scottish national radiological database based on specific imaging codes 2. Regional genetic/inherited cardiac conditions services 3. Public Health Scotland via specific diagnostic ICD-10 codes.
Key inclusion criteria (2 listed)
- all adults (>18 years of age) that underwent surgical intervention on the proximal aorta in Scotland between 2008 and 2021.
- all adult patients (>18 years of age) with a radiological, genetic or post-mortem diagnosis of thoracic aortic disease
Key exclusion criteria (2 listed)
- Isolated surgery on the descending thoracic aorta
- Non-surgical cohort
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 |
|---|---|---|
| Surgery on the proximal aorta (aortic root +/- ascending aorta)Surgery involving replacing, repairing or reinforcing the proximal aorta (root and ascending aorta) | Procedure or surgery | Surgical cohort |
| Patients diagnosed with thoracic aortopathy but not operated uponRadiological size criteria or Genetic mutations associated with aortopathies | Other | Non-surgical cohort |
Primary outcome
Early survival following surgery of the proximal aorta
Time frame: In-hospital or 30 days (whichever is longer)
In-hospital or 30 days survival following surgery of the proximal aorta
Late survival following surgery of the proximal aorta
Time frame: 5 years or latest available follow-up (whichever is longer)
Long-term survival following surgery of the proximal aorta
Patient demographics and geographic distribution of thoracic aortopathy within the Scottish population
Time frame: Cross-sectional analysis (2011-2021)
Identify the demographics (age, gender, relevant risk factors) and geographic distribution (area codes) of patients diagnosed with thoracic aortopathy within the Scottish population
5 secondary outcomes
Cardiovascular reintervention
Time frame: 1 year or latest available follow-up (whichever is longer)
Specified adverse events following surgery
Time frame: 1 year or latest available follow-up (whichever is longer)
Left ventricular ejection fraction (LVEF) following surgery
Time frame: 1 year or latest available follow-up (whichever is longer)
Aortic valve mean gradient and degree of regurgitation following surgery
Time frame: 1 year or latest available follow-up (whichever is longer)
Genotypes and phenotypes prevalent in the Scottish population
Time frame: Previous 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2024.
- Individual participant dataSharing planned: No. To apply for further studies, beyond the current research, using the existing dataset, a research proposal submitted to the GJNH Research Department will be required. This will follow the established internal peer-review process established by the GJNH research department. If approved, a data request form will need to be submitted to the data custodian who will release the pseudo- anonymised data to the research applicant. If there is no request to extend the study then this data will be deleted.
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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. This study is not recruiting at the moment.
George Gradinariu, MD principal investigator
Golden Jubilee National Hospital
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 Diseases and Aortic Dissection, run by Golden Jubilee National Hospital at 1 site in United Kingdom.
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: status not confirmed, as of the sponsor's last update on 15 Jul 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 United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early survival following surgery of the proximal aorta (time frame: In-hospital or 30 days (whichever is longer)). The study lists 3 primary outcomes in all. 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 Jul 2024.