Mortality and Morbidity Outcomes in Marfans

Sponsor
Barts & The London NHS Trust (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04774172
Collaborator
Liverpool Heart and Chest Hospital NHS Foundation Trust (Other), Aortic Dissection Awareness UK & Ireland. (Other)
10,000
4

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase

    Detailed 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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    10000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Mortality and Morbidity Outcomes After Aortovascular Surgery in Patients With Marfan Syndrome: A UK Experience
    Anticipated Study Start Date :
    Jul 1, 2022
    Anticipated Primary Completion Date :
    Oct 31, 2022
    Anticipated Study Completion Date :
    Oct 31, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Mortality mortality rate 1-year after surgery. Mortality rate 1 year after aorto-vascular surgery [1 year after surgery]

      mortality rate 1-year after surgery

    Secondary Outcome Measures

    1. Morbidity outcomes [within 1 year after surgery]

      (i) Underlying cause of death and multiple causes of death

    2. Morbidity outcomes [within 1 year after surgery]

      Date of each Finished Consultant Episode

    3. Morbidity outcomes [within 1 year after surgery]

      Primary and secondary diagnostic codes

    4. Morbidity outcomes [within 1 year after surgery]

      Primary procedural codes

    5. Morbidity outcomes [within 1 year after surgery]

      Hospital episode length

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 120 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Barts & The London NHS Trust
    • Liverpool Heart and Chest Hospital NHS Foundation Trust
    • Aortic Dissection Awareness UK & Ireland.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Barts & The London NHS Trust
    ClinicalTrials.gov Identifier:
    NCT04774172
    Other Study ID Numbers:
    • 294022
    First Posted:
    Mar 1, 2021
    Last Update Posted:
    Apr 5, 2022
    Last Verified:
    Mar 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 5, 2022