Central and Peripheral Blood Pressure in Stroke

NCT02537652 | Completed DMC

• 1 other identifier: 184563
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 2

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.

Conditions

Stroke, Acute; Blood Pressure

Keywords

Central blood pressure; Transient ischaemic attack

Outcome Measures

Primary Outcomes (1)

• Central blood pressure

  Central blood pressures will be assessed on three separate days in both a seated and supine posture when fasted and unfasted.

  10 months

Secondary Outcomes (3)

• Peripheral blood pressure

  10 months

• Augmentation index

  10 months

• Pulse pressure

  10 months

Study Arms (2)

Major Stroke

Patients diagnosed with major stroke who will undergo blood pressure assessment

Other: Blood pressure assessment

Minor stroke

Patients diagnosed with minor stroke who will undergo blood pressure assessment

Other: Blood pressure assessment

Interventions

Blood pressure assessment OTHER

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).

Major Stroke; Minor stroke

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hampshire Hospitals NHS Foundation Trust: lead
• University of Winchester: collaborator

Study Sites (2)

University of Winchester

Winchester, Hampshire, SO22 4HL, United Kingdom

Location

Acute Stroke Ward

Winchester, Hampshire, SO22 5DG, United Kingdom

Location

Related Publications (1)

• Mitchelmore A, Stoner L, Lambrick D, Sykes L, Eglinton C, Jobson S, Faulkner J. Oscillometric central blood pressure and central systolic loading in stroke patients: Short-term reproducibility and effects of posture and fasting state. PLoS One. 2018 Nov 1;13(11):e0206329. doi: 10.1371/journal.pone.0206329. eCollection 2018.

  PMID: 30383781 DERIVED

MeSH Terms

Conditions

Stroke; Ischemic Attack, Transient

Condition Hierarchy (Ancestors)

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

Study Officials

• Andrew Mitchelmore, MSc

  University of Winchester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2015
• First Posted: September 1, 2015
• Study Start: January 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: November 13, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will share

Locations

GB (2)