Cerebral Haemodynamics in Stroke Thrombolysis Study (CHIST)

NCT02928926 | Completed

• 1 other identifier: 0542
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

Cerebral autoregulation is an important mechanism whereby cerebral perfusion is normally maintained at a constant level, over a relatively wide blood pressure range. It can be assessed noninvasively by the use of Trans Cranial Doppler (TCD). This means using ultrasound probes over both sides of the head to measure changes in blood flow in one of the main brain arteries (the middle cerebral artery) in response to beat to beat changes in blood pressure dynamic cerebral autoregulation (dCA). It is established that dCA is impaired following moderate to severe stroke, acting as a key role in the development of secondary brain damage related to brain swelling and further damage related to low blood flow. The administration of clotbusting therapy (thrombolysis), one of the main approved treatments of acute ischaemic stroke (AIS), results in recanalization of the blocked artery in over approximately 50% patients. However, due to its clot dissolving property, it may increase the risk of bleeding in the body, especially in the brain, leading to greater disability or even death. To date, there has been very little information regarding the natural history and prognostic significance of impaired Cerebral Autoregulation during and following reperfusion, especially those who receive thrombolysis. This research will use the noninvasive technique of Trans Cranial Doppler (TCD) to see how blood flow changes in AIS patient at the initiation and completion of thrombolysis, and during acute, subacute and chronic phase post stroke onset, compared with those AIS patient who did not receive thrombolysis. This study will provide important data regarding perithrombolysis blood pressure management, an important and common clinical dilemma

Conditions

Ischaemic Stroke

Outcome Measures

Primary Outcomes (1)

• Change of the autoregulation index

  Change of the autoregulation index during intravenous thrombolysis infusion, 1 week and 3 months post stroke symptoms onset

  During intravenous thrombolysis infusion, 1 week and 3 months post stroke symptoms onset

Secondary Outcomes (1)

• Change of the dynamic cerebral autoregulation

  During intravenous thrombolysis infusion, 1 week and 3 months post stroke symptom onset

Study Arms (2)

Thrombolysis

Acute ischaemic stroke patients who receive intravenous thrombolysis

Other: intravenous thrombolysis

non thrombolysis

Acute ischaemic stroke patients who admitted to the hospital within the timeframe for intravenous thrombolysis but contraindicate to receive intravenous thrombolysis

Other: intravenous thrombolysis

Interventions

intravenous thrombolysis OTHER

patients who are eligible with intravenous thrombolysis or admitted within the timeframe to receive thrombolysis but not eligible due to other reasons

Thrombolysis; non thrombolysis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

11 clot busting (thrombolysis) treated acute ischaemic stroke patients and non thrombolysis treated acute ischaemic stroke patients

You may qualify if:

• Informed patient consent or personal consultee declaration form
• Male or female, aged 18 years or above
• Able (in the Investigator's opinion) and willing to comply with all study requirements
• Willing to allow his or her General Practitioner (GP) to be notified of participation in the study
• Who meet the criteria for thrombolytic therapy with intravenous rtPA
• Clinical diagnosis of stroke within 6 hours of onset but not eligible for rtPA therapy, and the reason recorded

You may not qualify if:

• Male or Female, aged under 18 years
• Unable (in the Investigator's opinion) or unwilling to comply with any study requirements
• Significant pre-stroke dependency (premorbid Modified Rankin Score \>3)
• Co-morbidity with anticipated life expectancy less than 3 months
• Current participation in another investigational drug trial
• Participants who do not meet the criteria for thrombolytic therapy with intravenous rtPA
• Clinical diagnosis of stroke greater than 6 hours from onset
• Having had a resolved transient ischaemic attack (TIA) (i.e. neurological symptoms completely resolved or rapidly improving within 1 hour of onset)

Sponsors & Collaborators

• University of Leicester: lead

Study Sites (1)

University Hosptial of Leicester NHS Trust

Leicester, LE1 5WW, United Kingdom

Location

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

• Thompson G Robinson, MD FRCP

  University of Leicester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2016
• First Posted: October 10, 2016
• Study Start: April 1, 2016
• Primary Completion: October 31, 2017
• Study Completion: October 31, 2017
• Last Updated: January 30, 2020

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)