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Cerebral Haemodynamics in Transient Ischaemic Attack

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ClinicalTrials.gov Identifier: NCT03886129
Recruitment Status : Not yet recruiting
First Posted : March 22, 2019
Last Update Posted : March 22, 2019
Sponsor:
Information provided by (Responsible Party):
University of Leicester

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.


Condition or disease Intervention/treatment
Transient Ischemic Attack Diagnostic Test: Transcranial Doppler Ultrasound (TCD)

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: The Assessment of Cerebral Haemodynamics in Patients With Transient Ischaemic Attack: A Transcranial Doppler Study
Estimated Study Start Date : April 2019
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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)
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

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)
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.




Primary Outcome Measures :
  1. Beat-to-beat brain blood flow velocity [ Time Frame: 6 months ]
    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.


Secondary Outcome Measures :
  1. Autoregulation index [ Time Frame: 6 months ]
    To determine other beat-to-beat brain blood flow parameters, specifically autoregulation index (ARI), of both TIA and HC subjects during performance of a squat-stand manoeuvre.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

INCLUSION CRITERIA:

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

EXCLUSION CRITERIA:

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

Information from the National Library of Medicine

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): NCT03886129


Contacts
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Contact: Victoria Haunton, MD +441162525802 vjh12@le.ac.uk

Sponsors and Collaborators
University of Leicester
Investigators
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Principal Investigator: Thompson G Robinson, MD University of Leicester
  Study Documents (Full-Text)

Documents provided by University of Leicester:
Informed Consent Form: TIA Participants  [PDF] February 20, 2019


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Responsible Party: University of Leicester
ClinicalTrials.gov Identifier: NCT03886129     History of Changes
Other Study ID Numbers: UNOLE 0694
First Posted: March 22, 2019    Key Record Dates
Last Update Posted: March 22, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description:

There is no plan to make individual participant data (IPD) available to other researchers.

Anonymised cohort data may be shared with researchers from other Departments or Universities conducting similar research. Explicit written consent for the sharing of such data will be obtained from participants.


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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Ischemia
Ischemic Attack, Transient
Pathologic Processes
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases