Differential Metabolic Signature of Stroke Patients Undergoing Thrombolysis (DETECT)
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|ClinicalTrials.gov Identifier: NCT03443245|
Recruitment Status : Recruiting
First Posted : February 23, 2018
Last Update Posted : July 8, 2019
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.
|Condition or disease|
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.
|Study Type :||Observational|
|Estimated Enrollment :||70 participants|
|Official Title:||Differential Metabolic Signature of Stroke Patients Undergoing Thrombolysis Compared to Healthy Controls|
|Actual Study Start Date :||July 3, 2019|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||March 2020|
Patient will have thrombolysis treatment as part of their standard care.
Healthy volunteers to act as control group for stroke patients.
- Measurement of succinate in the same patients before and immediately after thrombolysis [ Time Frame: Up to 12 months ]
- Baseline succinate measurement from age-matched healthy volunteers [ Time Frame: Up to 12 months ]
- Assessment of pre and post-thrombolysis blood from stroke patients vs healthy controls [ Time Frame: Up to 12 months ]Bloods will be screened using a metabolomics scanner to identify if there are any significant changes in the data
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03443245
|Contact: Thomas Krieg, MDfirstname.lastname@example.org|
|Contact: Gemma Bockingemail@example.com|
|Principal Investigator:||Thomas Krieg, MD||Cambridge University Hospital NHS Foundation Trust|