Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT06434012 |
| Other study ID # |
249740 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 24, 2019 |
| Est. completion date |
April 30, 2029 |
Study information
| Verified date |
May 2024 |
| Source |
Queen Mary University of London |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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
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, Radiology/Nuclear 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 confirmed/probable 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 17.1%
(51/298). Our current surgical mortality stands at 4.7% (14/298), which represents a
significant reduction compared to pre-merger where combined mortality at the individual
hospitals was 12.2%. In those patients who have died with medical management (37/51), the
vast majority have had advanced life-limiting non-cardiac co-morbidities that preclude
cardiac surgery (n=19) or on-going intravenous drug use after previous cardiac surgery for IE
(n=6). 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 DGH's
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.
