Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT04774172 |
| Other study ID # |
294022 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
December 1, 2023 |
| Est. completion date |
March 30, 2024 |
Study information
| Verified date |
June 2023 |
| Source |
Barts & The London NHS Trust |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Marfan Syndrome (MFS) is a genetic disease affecting the eyes, skeleton, heart and arteries.
Despite MFS affecting multiple organ systems, cardiovascular manifestations are the most
serious and life threatening. Approximately 80% of adult MFS patients will have a dilated
aortic root by age 40 years with aortic aneurysm and dissection the leading causes of
morbidity and mortality. Improvement in diagnostics and medical and surgical interventions
have increased life expectancy. However, the natural history and the influence of medical or
surgical interventions in the UK population are not fully described. Further, the incidence
of aortovascular surgery in this patient group is unknown as MFS is not routinely documented
in the National Institute of Cardiovascular Outcome Research (NICOR) national cardiac surgery
dataset and therefore, there is currently no mechanism for exploring the aortovascular
outcomes for this patient group.
The investigators aim to undertake a 10-year secondary analysis of linked national data
(National Institute of Cardiovascular Outcome Research (NICOR), Office of National Statistics
(ONS), Hospital Episode Statistics (HES)) to identify the UK incidence and outcome of
aorto-vascular surgery in patients with Marfan syndrome (MFS). This includes associated
hospital length of stay, mortality and morbidity rates.
Understanding mortality alongside morbidity will allow the investigators to study further the
burdens that the aortovascular manifestations may place on MFS population as well as to
continuously evaluate the efficacy of either the health care system or an implemented
intervention in place. Further, these metrics will be useful for the stakeholders to
effectively prioritise which complications to tackle and to allocate resources toward as well
as proactively manage the potential onset of a health event
Description:
Marfan Syndrome (MFS) is a genetic disease affecting the eyes, skeleton, heart and arteries.
Despite MFS affecting multiple organ systems, cardiovascular manifestations are the most
serious and life threatening. Approximately 80% of adult MFS patients will have a dilated
aortic root by age 40 years with aortic aneurysm and dissection the leading causes of
morbidity and mortality. Improvement in diagnostics and medical and surgical interventions
have increased life expectancy. However, the natural history and the influence of medical or
surgical interventions in the UK population are not fully described. Further, the incidence
of aortovascular surgery in this patient group is unknown as MFS is not routinely documented
in the National Institute of Cardiovascular Outcome Research (NICOR) national cardiac surgery
dataset and therefore, there is currently no mechanism for exploring the aortovascular
outcomes for this patient group.
The investigators aim to undertake a 10-year secondary analysis of linked national data
(National Institute of Cardiovascular Outcome Research (NICOR), Office of National Statistics
(ONS), Hospital Episode Statistics (HES)) to identify the UK incidence and outcome of
aorto-vascular surgery in patients with Marfan syndrome (MFS). This includes associated
hospital length of stay, mortality and morbidity rates.
Understanding mortality alongside morbidity will allow the investigators to study further the
burdens that the aortovascular manifestations may place on MFS population as well as to
continuously evaluate the efficacy of either the health care system or an implemented
intervention in place. Further, these metrics will be useful for the stakeholders to
effectively prioritise which complications to tackle and to allocate resources toward as well
as proactively manage the potential onset of a health event.
