Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06434012
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-30
First Post:
2024-05-23
Brief Title:
Barts Endocarditis Research Registry
Sponsor:
Queen Mary University of London
Organization:
Queen Mary University of London
Study Overview
Official Title:
Barts Endocarditis Research Registry
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The Barts Endocarditis Research Registry is being set up to give a unique opportunity to assess the characteristics of Infective Endocarditis IE in our population cohort the current use of imaging techniques as well as the implementation of the ESC guidelines and its consequence in terms of prognosis All this will help improve the diagnosis and management of IE The registry will also form the core of all our subsequent work including interventional studies The endocarditis research registry is to record the epidemiological demographic microbiological surgical and outcome data in our cohort of endocarditis patients This work will underpin all future work in endocarditis by clearly defining our patient cohort and the outcomes from treatment We have a series of studies planned that we believe will influence the management of endocarditis we are working up proposals for genomic and therapeutic trials that will subsequently be presented for ethical and hospital approval The registry will be generic to all our planned studies and will allow us to capture data to assess treatment effectiveness
Detailed Description:
This research registry will give us the unique opportunity to assess the characteristics of IE in our population cohort the current use of imaging techniques as well as the implementation of the ESC guidelines and its consequence in terms of prognosis All this will help improve the diagnosis and management of IE The registry will also form the core of all our subsequent work including interventional studies
Infective endocarditis IE is a rare but serious disease associated with high morbidity and in-hospital mortality Despite improvements in diagnostic and therapeutic strategies the mortality remains at 15-30 in most published studies The reasons for this persistent poor prognosis are numerous and include older patients with more severe disease changes in the epidemiologic profiles and more patients with prosthetic or device related IE
Following the formation of Barts Heart Centre BHC there was a sharp and noticeable increase in the number of patients with infective endocarditis IE referred to our centre Recognising this change the complexity of patients and the coincident publication of the European Society of Cardiology Guidelines on Infective Endocarditis 2015 our Specialised Cardiology Directorate set up a new referral pathway Standard Operating Procedure and Endocarditis Team meeting MDT The aim was to ensure focussed consistent and evidence-based care with joint medical and surgical input to this unique group of very unwell patients with high inpatient mortality In addition the MDT would discuss and co-ordinate the care of all IE patients with a weekly discussion of those on site as well as at our referring hospitals The MDT started in October 2015 and is composed of representatives from Cardiology including imaging Cardiac Surgery Microbiology RadiologyNuclear Medicine and Pharmacy
Since its inception the MDT has discussed 367 patients at BHC and our wider referral centres October 2015 - January 2018 Of those patients 298 have been confirmedprobable as having IE 144 surgically managed 139 medically managed 16 device extractions with intracardiac infection all following international guidance This does not include the grown-up congenital heart disease patients who are discussed and managed separately
An audit database to track outcomes was started in January 2018 but there is a need to expand this work and make a registry that will form the foundation of all other research that we will undertake
Mortality across the cohort has been at the lower end of international publications at 171 51298 Our current surgical mortality stands at 47 14298 which represents a significant reduction compared to pre-merger where combined mortality at the individual hospitals was 122 In those patients who have died with medical management 3751 the vast majority have had advanced life-limiting non-cardiac co-morbidities that preclude cardiac surgery n19 or on-going intravenous drug use after previous cardiac surgery for IE n6 Six patients have not been referred in time for surgery having presented locally with septic shock and deteriorated rapidly and this is an area of further education for our referring centres Six patients have had operations without intra-operative evidence of infection However these patients had indications for surgery due to haemodynamically significant regurgitant valve disease
Our morbidity and mortality reviews have allowed us to learn from all these cases across all specialties and imaging modalities
Not only has this approach led to improvements in patient care but it has also raised the profile of BHC as a centre of special expertise Our referring centres now include the DGHs of Barts Health NHS Trust Whipps Cross University Hospital Newham University Hospital and The Royal London Hospital plus many other district general hospitals in our locale
Infective endocarditis IE is a rare but serious disease associated with high morbidity and in-hospital mortality Despite improvements in diagnostic and therapeutic strategies the mortality remains at 15-30 in most published studies The reasons for this persistent poor prognosis are numerous and include older patients with more severe disease changes in the epidemiologic profiles and more patients with prosthetic or device related IE
Following the formation of Barts Heart Centre BHC there was a sharp and noticeable increase in the number of patients with infective endocarditis IE referred to our centre Recognising this change the complexity of patients and the coincident publication of the European Society of Cardiology Guidelines on Infective Endocarditis 2015 our Specialised Cardiology Directorate set up a new referral pathway Standard Operating Procedure and Endocarditis Team meeting MDT The aim was to ensure focussed consistent and evidence-based care with joint medical and surgical input to this unique group of very unwell patients with high inpatient mortality In addition the MDT would discuss and co-ordinate the care of all IE patients with a weekly discussion of those on site as well as at our referring hospitals The MDT started in October 2015 and is composed of representatives from Cardiology including imaging Cardiac Surgery Microbiology RadiologyNuclear Medicine and Pharmacy
Since its inception the MDT has discussed 367 patients at BHC and our wider referral centres October 2015 - January 2018 Of those patients 298 have been confirmedprobable as having IE 144 surgically managed 139 medically managed 16 device extractions with intracardiac infection all following international guidance This does not include the grown-up congenital heart disease patients who are discussed and managed separately
An audit database to track outcomes was started in January 2018 but there is a need to expand this work and make a registry that will form the foundation of all other research that we will undertake
Mortality across the cohort has been at the lower end of international publications at 171 51298 Our current surgical mortality stands at 47 14298 which represents a significant reduction compared to pre-merger where combined mortality at the individual hospitals was 122 In those patients who have died with medical management 3751 the vast majority have had advanced life-limiting non-cardiac co-morbidities that preclude cardiac surgery n19 or on-going intravenous drug use after previous cardiac surgery for IE n6 Six patients have not been referred in time for surgery having presented locally with septic shock and deteriorated rapidly and this is an area of further education for our referring centres Six patients have had operations without intra-operative evidence of infection However these patients had indications for surgery due to haemodynamically significant regurgitant valve disease
Our morbidity and mortality reviews have allowed us to learn from all these cases across all specialties and imaging modalities
Not only has this approach led to improvements in patient care but it has also raised the profile of BHC as a centre of special expertise Our referring centres now include the DGHs of Barts Health NHS Trust Whipps Cross University Hospital Newham University Hospital and The Royal London Hospital plus many other district general hospitals in our locale
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None