Cardiac pacing for the prevention of falls in carotid sinus hypersensitivity

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof RA Kenny
Scientific

Cardiovascular Investigation Unit
Ward 15 Offices
Royal Victoria Infirmary
Queen Victoria Road
Newcastle upon Tyne
NE14 4AH
United Kingdom

Phone	+44 (0)191 2225316
Email	R.A.Kenny@ncl.ac.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	To determine: 1. The prevalence of unexplained or recurrent falls in cognitively normal adult accident and emergency attendees 2. The prevalence of carotid sinus hypersensitivity in those who fall 3. Whether cardiac pacing reduces the frequency of falls in a prospective series of patients with cardioinhibitory carotid sinus hypersensitivity
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Carotid sinus syndrome
Intervention	Cardiac pacemaker versus Thera rate drop responsive Medtronic Inc dual chamber pacemaker.
Intervention type	Other
Primary outcome measure(s)	Added 16/02/2009: Number of patients who fall in the 24 months following intervention.
Key secondary outcome measure(s)	Added 16/02/2009: 1. Frequency of falls 2. Dizzy symptoms and presyncope 3. Perceived health and mental status including informants perception and patients perception 4. Injury rates 5. Use of primary, secondary and tertiary care facilities 6. Length of hospital admission 7. Change in residential circumstances 8. Cognitive function
Completion date	01/10/1999

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	20
Key inclusion criteria	Added 16/02/2009: 1. Aged greater than or equal to 50 years, either sex 2. A minimum of two unexplained falls, +/- up to one syncope, in the previous 12 months 3. Mini Mental State Examination (MMSE) greater than 20/30 4. Sinus rhythm 5. Greater than 3 s asystole (upright or supine) during carotid sinus massage (CSM) (i.e. cardio-inhibitory carotid sinus hypersensitivity) 6. Gait, balance, and vision, as assessed by attending physician, not attributable cause of falls Initial information at time of registration: Patients with a history of unexplained falls with reproducible cardio-inhibitory or mixed carotid sinus hypersensitivity
Key exclusion criteria	Added 16/02/2009: 1. Contraindication to CSM 2. Atrial fibrillation 3. Medications which enhance vagal activity 4. Neoplasm 5. Chronic renal failure 6. Chronic liver disease 7. Heart failure (New York Heart Association [NYHA] class III/IV)
Date of first enrolment	01/10/1998
Date of final enrolment	01/10/1999

Cardiovascular Investigation Unit

Newcastle upon Tyne
NE14 4AH
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/03/2009		Yes	No
Protocol article	protocol/initial results	01/01/1999		Yes	No