Differential Metabolic Signature of Stroke Patients Undergoing Thrombolysis

NCT03443245 | Completed DMC

• 1 other identifier: A094594
• Study Type: observational
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke, Ischemic

Outcome Measures

Primary Outcomes (2)

• Measurement of succinate in the same patients before and immediately after thrombolysis

  Up to 12 months

• Baseline succinate measurement from age-matched healthy volunteers

  Up to 12 months

Secondary Outcomes (1)

• Assessment of pre and post-thrombolysis blood from stroke patients vs healthy controls

  Up to 12 months

Study Arms (2)

Stroke patients

Patient will have thrombolysis treatment as part of their standard care.

Healthy Volunteers

Healthy volunteers to act as control group for stroke patients.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Secondary care (stroke patients via hospital Accident and Emergency unit and stroke wards) Healthy volunteers - invitation to participate from posters displayed in and around secondary care setting

You may qualify if:

• Be aged 18 years or over
• Present at Addenbrooke's Hospital A\&E with a stroke (ischaemic stroke)
• Time of onset of confirmed stroke symptoms within 4 hours of arrival in ED
• Be eligible for thrombolysis
• Provide informed consent either prior to thrombolysis or after the initial emergency; or personal or nominated consultee declaration following the emergency
• Be aged 18 years or over
• Provide informed consent
• Be healthy as determined by clinical history and examination by the investigator, a brief physical examination must be unremarkable.

You may not qualify if:

• Patients qualifying for thrombolysis but who do not give consent
• Patients under the age of 18
• Patients who are currently actively involved with another clinical trial (including observational studies)
• Unable to provide informed written consent
• Participants under the age of 18
• Participants who are currently actively involved with another clinical trial (including observational studies)

Sponsors & Collaborators

• Cambridge University Hospitals NHS Foundation Trust: lead

Study Sites (1)

Cambridge University Hospitals NHS Foundation Trust

Cambridge, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood samples

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Thomas Krieg, MD

  Cambridge University Hospital NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: University Lecturer and Honorary Consultant

Study Record Dates

• First Submitted: February 16, 2018
• First Posted: February 23, 2018
• Study Start: July 3, 2019
• Primary Completion: August 31, 2020
• Study Completion: August 8, 2021
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)