Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Central and Peripheral Blood Pressure in Stroke

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02537652
Recruitment Status : Completed
First Posted : September 1, 2015
Last Update Posted : November 13, 2017
Sponsor:
Collaborator:
University of Winchester
Information provided by (Responsible Party):
Hampshire Hospitals NHS Foundation Trust

Brief Summary:

Individuals who experience a stroke or transient ischaemic attack (TIA) are at heightened risk of subsequent vascular events, including heart attacks and secondary stroke/TIA. Blood pressure control is considered the most important contributor to positive health outcomes in stroke patients. The measurement of central blood pressure (cSBP) (the blood pressure which is being exerted at the heart), may provide clinicians with important diagnostic and prognostic information over and above that typically obtained from a peripheral blood pressure measure (the blood pressure in the arm). Central blood pressures may be better than traditional peripheral blood pressure measures as: i) peripheral blood pressure may not accurately reflect the effects of peak arterial blood pressure on centrally located organs, ii) central blood pressures may be 50 % superior to peripheral blood pressures when predicting cardiovascular events, and iii) information pertaining to central blood pressures may be more effective in the management of hypertension. While the validity of oscillometric devices which measure central blood pressures has been demonstrated, further study is required to determine precision under normal clinical operating conditions (i.e., reflective of the Hospital/GP practice setting). As such, this study will assess central and peripheral blood pressures of stroke patients when fasted and nonfasted, and when seated and supine. The study is interested in identifying the effect of the above parameters (fasted vs. unfasted, seated vs. supine) on central and peripheral blood pressures in stroke patients.

Participants will take part in three separate assessment sessions, on three separate days, with a minimum 24 hour recovery between each session. Each assessment is expected to last 90 minutes, with a minimum of eight blood pressures being taken from the left upper arm. As such, participants will be asked to give up 4.5 hours of their time to the study. During each assessment participants will be tested in a fasted and non-fasted state, and in a supine (lying) and seated position. All assessments will take place between 7 and 10am and will be undertaken following written informed consent.


Condition or disease Intervention/treatment
Stroke, Acute Blood Pressure Other: Blood pressure assessment

Show Show detailed description

Layout table for study information
Study Type : Observational
Actual Enrollment : 29 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Effect of Posture and Fasting State on Central and Peripheral Blood Pressure in Patients With Stroke
Study Start Date : January 2016
Actual Primary Completion Date : July 2017
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Major Stroke
Patients diagnosed with major stroke who will undergo blood pressure assessment
Other: Blood pressure assessment
Participants will undertake an overnight fast prior to each assessment (only water is allowed to be consumed prior to the assessment). Participants will take their medication the morning of each assessment in accordance with the normal pharmacological management procedures which are used on the acute stroke ward at the Royal Hampshire County Hospital. Following this, participants will rest supine (on an electrically operated bed) for a minimum of 15 minutes. Oscillometric pressure waveforms (using the SphygmoCor XCEL), recorded on the left upper arm, will assess haemodynamic parameters including central and peripheral blood pressure, pulse pressure, and augmentation index (fasted, supine condition).

Minor stroke
Patients diagnosed with minor stroke who will undergo blood pressure assessment
Other: Blood pressure assessment
Participants will undertake an overnight fast prior to each assessment (only water is allowed to be consumed prior to the assessment). Participants will take their medication the morning of each assessment in accordance with the normal pharmacological management procedures which are used on the acute stroke ward at the Royal Hampshire County Hospital. Following this, participants will rest supine (on an electrically operated bed) for a minimum of 15 minutes. Oscillometric pressure waveforms (using the SphygmoCor XCEL), recorded on the left upper arm, will assess haemodynamic parameters including central and peripheral blood pressure, pulse pressure, and augmentation index (fasted, supine condition).




Primary Outcome Measures :
  1. Central blood pressure [ Time Frame: 10 months ]
    Central blood pressures will be assessed on three separate days in both a seated and supine posture when fasted and unfasted.


Secondary Outcome Measures :
  1. Peripheral blood pressure [ Time Frame: 10 months ]
    Peripheral blood pressures will be assessed on three separate days in both a seated and supine posture when fasted and unfasted.

  2. Augmentation index [ Time Frame: 10 months ]

    Augmentation index will be assessed on three separate days in both a seated and supine posture when fasted and unfasted. Augmentation index is a parameter obtained during the central and peripheral blood pressure assessment (it is not a separate stand alone measure).

    The augmentation index is a ratio calculated from the blood pressure waveform, it is a measure of wave reflection and arterial stiffness.


  3. Pulse pressure [ Time Frame: 10 months ]
    Pulse pressure will be assessed on three separate days in both a seated and supine posture when fasted and unfasted.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients diagnosed with a major stroke, minor stroke or TIA by a stroke consultant at a local hospital will be eligible to participate.
Criteria

Inclusion Criteria:

  • Patients diagnosed with major stroke, minor stroke or TIA by a member of the clinical team.
  • Reside within the locality of the Hampshire Hospital's Foundation Trust
  • Patients are to be assessed within 8 weeks of their initial stroke/TIA diagnosis.
  • Do not meet exclusion criteria

Exclusion Criteria:

  • end of life stroke patients;
  • Unstable cardiac conditions
  • oxygen dependence
  • significant dementia; patients lacking capacity to consent to participate in study
  • unable to swallow
  • Patient is diagnosed with major stroke, minor stroke or TIA more than 8 weeks prior to an assessment

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): NCT02537652


Locations
Layout table for location information
United Kingdom
University of Winchester
Winchester, Hampshire, United Kingdom, SO22 4HL
Acute Stroke Ward
Winchester, Hampshire, United Kingdom, SO22 5DG
Sponsors and Collaborators
Hampshire Hospitals NHS Foundation Trust
University of Winchester
Investigators
Layout table for investigator information
Principal Investigator: Andrew Mitchelmore, MSc University of Winchester
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Hampshire Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02537652    
Other Study ID Numbers: 184563
First Posted: September 1, 2015    Key Record Dates
Last Update Posted: November 13, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data will be anonymised before it is shared outside the clinical study team
Keywords provided by Hampshire Hospitals NHS Foundation Trust:
Central blood pressure
Transient ischaemic attack
Additional relevant MeSH terms:
Layout table for MeSH terms
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases