Download Research Information Sheet for Practices

Research Information Sheet for Practices
Study Title
Sponsor
Funders
Chief Investigator
Study design
Primary Study Aim &
Objectives
Practice target & study
duration
Cerebral vasomotor regulation in atrial fibrillation (CVR-AF)
University of Birmingham
British Heart Foundation
Dr James Fisher
This is a single centre, cross-sectional, case control study.
Compare cerebral vasomotor regulation in atrial fibrillation patients, ‘disease controls’
(patients with essential hypertension in sinus rhythm), and healthy controls with
normal sinus rhythm.
PIC Activity Only (All the research activity will take place at the secondary care site, City
Hospital)
Inclusion Criteria
Atrial fibrillation patients
 Chronic atrial fibrillation established on ECG or Holter monitoring
 Men and women
 Aged 18 years and over
‘Disease’ control patients
 Patients in sinus rhythm with high blood pressure (systolic blood pressure >140
mmHg, and/or diastolic blood pressure >90 mmHg)
 Men and women
 Aged 18 years and over
Summary of Eligibility
Criteria (refer to Protocol
for full criteria)
Healthy control subjects
 Healthy control subjects in sinus rhythm and with normal blood pressure
(systolic blood pressure <130 mmHg and diastolic blood pressure <90 mmHg)
 Not taking any prescription or over-the-counter medications (other than oral
contraceptive pill)
 Men and women
 Aged 18 years and over
Exclusion Criteria
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Version 1 25/04/2016
Current use of oral nitrates
Evidence of valvular heart disease
Left ventricular dysfunction
Recent acute coronary syndrome (<3 months)
Cancer
Connective tissue or inflammatory disease
Neurological disease
Severe respiratory disease (e.g., chronic obstructive pulmonary disease)
Infection or pyrexial illness
Uncontrolled thyroid disorders
Hormone replacement therapy
Hepatic or renal impairment
CVR AF
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Core Practice Activities
Outside the stated age range
Pregnancy
Underlying medical conditions, which in the opinion of the Investigator place
the participant at unacceptably high risk for participating in the study
Inability to fully or appropriately participate in the study
1) Complete a database search and check lists for exclusions
2) Send Invite letters to patients
(All interested patients will contact the secondary care site, there will be no further
practice activity)
 Your practice will receive a £227* search fee for the initial practice database search
and mailing.
Practice Reimbursements *Values are an indication and can vary depending on number of patients entered into
the study from your practice.
Patient Involvement
See Flowchart Below
Resources provided by
the study team
Clinical Research Network and the study team
Local CRN contacts: Saif Uddin [email protected] 0121 414 8614
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CVR AF
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STUDY FLOW CHART
Practice Involvement
Patient Involvement
1) Complete a database search and
check lists for exclusions
2) Send patient invites in the post
Recruitment
Arrive at hospital for study visit
Reminder of procedures, any ques ons answered,
wri en informed consent
Height, weight, and body composi on recorded.
Disease/demographic informa on obtained
Venous blood sample taken
Cogni ve func on assessed
Flow mediated dilata on
Set up and monitoring of the cardiovascular system,
respira on and cerebral blood flow
Cerebral vasomotor regula on assessment
Physical ac vity monitoring and health ques onnaires
Version 1 25/04/2016
CVR AF
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