Cerebral Haemodynamics in Transient Ischaemic Attack

NCT03886129 | Terminated

• 1 other identifier: 0694
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

Adequate brain blood flow is essential for brain survival and function. Brain blood flow is kept relatively constant by a process called cerebral autoregulation (CA). CA is impaired in various diseases including head injury, diabetes, Alzheimer's, pre-eclampsia and stroke. In stroke, impaired CA is associated with poor outcomes. A transient ischaemic attack (TIA) is the same as a stroke, except the symptoms only last for a short amount of time and resolve spontaneously. TIAs are sometimes called mini-strokes and are a major warning sign of strokes. There have been lots of studies of CA in stroke, but very few studies of CA in TIA. Brain blood flow and CA can be studied non-invasively with Transcranial Doppler ultrasound (TCD). Study aim: To investigate whether CA is impaired in patients with TIA 20 patients with acute TIA (within 7 days), and 20 healthy controls will be recruited from the specialist TIA clinic at University Hospitals of Leicester NHS Trust. Participants will be eligible if they are aged over 18 and can consent to participate. They won't be able to participate if they have severe heart failure, an irregular heartbeat, blocked neck blood vessels, severe breathing problems, or if they are pregnant. Participants will undergo an assessment of brain blood flow using TCD, during which their heart rate, breathing and blood pressure will also be monitored. During the assessment participants will sit quietly before being asked to stand and then complete a squat-stand manoeuvre in time with a computer sequence. The research visit will take approximately 90 minutes, the assessment itself will take approximately 1 hour and participants only need to attend once.

Conditions

Transient Ischemic Attack

Outcome Measures

Primary Outcomes (1)

• Beat-to-beat brain blood flow velocity

  To determine the beat-to-beat brain blood flow velocity of both TIA and Healthy Control (HC) subjects during performance of a squat-stand manoeuvre.

  6 months

Secondary Outcomes (1)

• Autoregulation index

  6 months

Study Arms (2)

Participants with Transient Ischaemic Attack

Inclusion Criteria: * Willing to participate * Capacity to consent * Aged \>18 years * Able (in the Investigator's opinion) and willing to comply with all study requirements * A diagnosis of acute (≤7 days) TIA, made by a specialist that fulfils the 2009 American Heart Association definition of TIA * Good understanding of written and verbal English Exclusion Criteria: * Unwilling to take part * Unable to consent * Aged \<18 years * Unable (in the Investigator's opinion) or unwilling to comply with any study requirements * Female participants who are pregnant, lactating or planning pregnancy during the course of the study * Atrial fibrillation * Severe heart failure (Ejection Fraction \<30%) * Severe respiratory disease * Inadequate bilateral transcranial Doppler windows * Carotid stenosis ≥70% (unilateral or bilateral) * Participant enrolled in an interventional research study. * Poor understanding of written and verbal English

Diagnostic Test: Transcranial Doppler Ultrasound (TCD)

Healthy Control Participants

Inclusion Criteria: * Willing to participate * Capacity to consent to the study * Aged \>18 years * Able (in the Investigator's opinion) and willing to comply with all study requirements * Good understanding of written and verbal English Exclusion Criteria: * Unwilling to take part * Unable to consent * Aged \<18 years * Unable (in the Investigator's opinion) or unwilling to comply with any study requirements * Female participants who are pregnant, lactating or planning pregnancy during the course of the study * Atrial fibrillation * Severe heart failure (Ejection Fraction \<30%) * Severe respiratory disease * Inadequate bilateral transcranial Doppler windows * Carotid stenosis ≥70% (unilateral or bilateral) * Participant enrolled in an interventional research study. * Poor understanding of written and verbal English

Diagnostic Test: Transcranial Doppler Ultrasound (TCD)

Interventions

Transcranial Doppler Ultrasound (TCD) DIAGNOSTIC_TEST

Participants will undergo an assessment of brain blood flow using TCD, with two small ultrasound probes held in place on the temples with a customised headframe. During the assessment, heart rate, breathing and blood pressure will also be monitored using a 3 lead ECG, nasal capnography and Finometer® respectively. The assessment will comprise three recordings. Firstly, participants will sit quietly for 5 minutes. Next, they will be asked to sit quietly for one minute before standing and remaining standing for 5 minutes. Lastly, they will be asked to stand and then complete a squat-stand manoeuvre in time with a computer sequence. A tilt sensor attached to the thigh will measure the efficiency and angle of the squatting motion. The squat-stand manoeuvre will consist of 15 squats and participants will be informed that they should try and complete all 15 squats if possible.

Healthy Control Participants; Participants with Transient Ischaemic Attack

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

20 adult patients with acute TIA (within 7 days), and 20 healthy controls will be recruited from the specialist TIA clinic at University Hospitals of Leicester NHS Trust.

You may qualify if:

• HEALTHY CONTROLS:
• Willing to participate
• Capacity to consent to the study
• Aged over 18 years
• Able (in the Investigator's opinion) and willing to comply with all study requirements
• Good understanding of written and verbal English
• TIA PATIENTS:
• Willing to participate
• Capacity to consent to the study
• Aged over 18 years
• Able (in the Investigator's opinion) and willing to comply with all study requirements
• A diagnosis of acute (≤7 days) TIA, made by a specialist in the TIA clinic at University Hospitals of Leicester NHS Trust that fulfils the 2009 American Heart Association definition of TIA
• Good understanding of written and verbal English

You may not qualify if:

• ALL PARTICIPANTS (HEALTHY CONTROLS AND TIA PATIENTS)
• Unwilling to take part
• Unable to consent
• Aged under 18 years
• Unable (in the Investigator's opinion) or unwilling to comply with any study requirements
• Female participants who are pregnant, lactating or planning pregnancy during the course of the study
• A diagnosis of atrial fibrillation
• A diagnosis of severe heart failure (Ejection Fraction \<30%)
• Severe respiratory disease
• Inadequate bilateral transcranial Doppler windows (see section 8.3)
• Carotid stenosis ≥70% (unilateral or bilateral)
• Participant enrolled in an interventional research study.
• Poor understanding of written and verbal English

Sponsors & Collaborators

• University of Leicester: lead

Study Sites (1)

University Hospitals of Leicester NHS Trust

Leicester, United Kingdom

Location

MeSH Terms

Conditions

Ischemic Attack, Transient

Interventions

Ultrasonography, Doppler, Transcranial

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Echoencephalography; Neuroradiography; Neuroimaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiography; Ultrasonography; Ultrasonography, Doppler; Diagnostic Techniques, Neurological; Investigative Techniques

Study Officials

• Thompson G Robinson, MD

  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: March 20, 2019
• First Posted: March 22, 2019
• Study Start: April 16, 2019
• Primary Completion: March 31, 2021
• Study Completion: March 31, 2021
• Last Updated: May 28, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)