Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03443245 |
| Other study ID # |
A094594 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 3, 2019 |
| Est. completion date |
August 8, 2021 |
Study information
| Verified date |
February 2023 |
| Source |
Cambridge University Hospitals NHS Foundation Trust |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Currently, there is no reliable biomarker for stroke, meaning that treatment is often delayed
and patients are often left with a disability. Stroke is one of the largest causes of
mortality (death) and morbidity (disease) in the UK and affects around 120 and 15 people per
100,000 population. This has huge economic implications, with around £9 billion a year being
spent on stroke in the UK alone, and health and social care costs accounting for half of this
amount. Productivity losses (i.e. income costs) are estimated at £1.33 billion and benefit
payments total £840 million per year.
Previous studies involving heart attack patients have suggested that succinate (a biomarker)
levels rise after reperfusion (reoxygenation) of the heart tissue and in the context of
ischaemia (i.e. when a restriction of blood supply to the heart has caused a heart attack and
the tissue has been reoxygenated to improve blood flow around the body). Malonate is a
therapeutic option to block this rise in succinate and reduce any potential resulting damage.
Animal studies support these findings and have further shown that malonate prevents ischaemic
brain damage and reduces the succinate increase in tissue.
However, there is currently no pre-clinical data for the release of succinate into blood, nor
for stroke. This study aims to explore whether elevated succinate levels are present in
stroke patients having thrombolysis (brain reperfusion). If we can show that elevated
succinate levels are attributed to stroke (and not a result of thrombolysis), it might be
possible to identify a therapeutic intervention at baseline for these patients and this
reduce disability in all stroke patients, and healthcare costs in turn.
Description:
There are around 150,000 incidents of stroke every year in the UK alone. By the age of 75, 1
in 5 women and 1 in 6 men will have had a stroke; 26% of which will have occurred before the
age of 65. Moreover, over half of all stroke survivors are left with a disability and 41% of
these are discharged from hospital requiring help with daily activities. Without a reliable
biomarker for stroke patients, the development of a therapeutic intervention at baseline
which has the capability to reduce disability in stroke patients is not possible. There is a
dire need for further research into stroke. In 2012, £56 million was spent on stroke-related
care/research, compared to £544 million on cancer research and £166 million on heart disease.
Studies involving heart attack patients suggest that succinate could be used as a biomarker
for stroke patients. Furthermore, the current therapeutic option used to block the rise in
succinate levels, malonate, has been shown to prevent ischaemic brain damage in animal
studies. No work to date has explored this phenomenon in humans with stroke and therefore
this study has huge potential to bridge the gap in helping to treat stroke patients in the
future and thus reduce healthcare costs.
The DETECT study is a pilot study and has been specifically designed to be as simple as
possible. For stroke patients undergoing thrombolysis, they will already have a cannula
inserted to aid with the procedure. We propose that research bloods could be taken from this
same cannula to reduce the burden to the patient. Wherever possible we will conduct the
safety follow-up with stroke patients whilst they are still an inpatient at the hospital, to
again reduce the burden to the patient.
