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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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 10000
Est. completion date March 30, 2024
Est. primary completion date March 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 120 Years
Eligibility Inclusion Criteria: - >/= 18 years old at the time of surgery - Identified MFS in the HES database using the ICD diagnosis code Q874 between January 2010- December 2019 - Had an aorto-vascular surgery in England and Wales, as identified in the NICOR Adult Cardiac Surgery database Exclusion Criteria: - < 18 years old at the time of surgery

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
Barts & The London NHS Trust Aortic Dissection Awareness UK & Ireland., Liverpool Heart and Chest Hospital NHS Foundation Trust

Outcome

Type Measure Description Time frame Safety issue
Primary Mortality mortality rate 1-year after surgery. Mortality rate 1 year after aorto-vascular surgery mortality rate 1-year after surgery 1 year after surgery
Secondary Morbidity outcomes (i) Underlying cause of death and multiple causes of death within 1 year after surgery
Secondary Morbidity outcomes Date of each Finished Consultant Episode within 1 year after surgery
Secondary Morbidity outcomes Primary and secondary diagnostic codes within 1 year after surgery
Secondary Morbidity outcomes Primary procedural codes within 1 year after surgery
Secondary Morbidity outcomes Hospital episode length within 1 year after surgery
See also
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Completed NCT01715207 - Comparison Study of the Effect of Aliskiren Versus Negative Controls on Aortic Stiffness in Patients With Marfan Syndrome Under Treatment With Atenolol Phase 3
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Recruiting NCT04776681 - Living With Marfans and Your Aorta: Surgical Outcomes Study
Completed NCT03236571 - Cardiorespiratory and Muscular Rehabilitation of Children and Young Adults With Marfan Syndrome. N/A