This study that documents the changes in heart rate, muscle sympathetic nerve activity, stroke volume and systemic vascular resistance in response to supine and head up tilted carotid sinus massage in elderly subjects.
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
This study intends to describe the changes in sympathetic tone and systemic
vascular resistance during carotid sinus massage while supine and head-up
tilted.
Secondary outcome
n.a.
Background summary
Falls in the elderly are a huge medical problem. They lead to enormous
morbidity and co-morbidity. Syncope is an important etiological factor for
falls. One of the causes of syncope in the elderly is carotid sinus
hypersensitivity (CSH). The prevalence of carotid sinus hypersensitivity (i.e.
a positive test in a syncope patient without a typical history of loss of
consciousness following neck manipulation) in the general population is between
1 and 25%, occurring primarily in older patients, with a strongly positive
correlation with age.
Study objective
This study that documents the changes in heart rate, muscle sympathetic nerve
activity, stroke volume and systemic vascular resistance in response to supine
and head up tilted carotid sinus massage in elderly subjects.
Study design
Patients will be studied during carotid sinus massage:
1. Microneurography: Multiunit post-ganglionic muscle sympathetic nerve
activity will be recorded from the peroneal nerve posterior to the fibular head
with a tungsten microelectrode. This technique has been in use world-wide
since the early 1970*s.
2. Cardiac output: computed continuous cardiac output from blood pressure wave
form with inert gas rebreathing validation . From cardiac output and blood
pressure continuous absolute systemic vascular resistance can be determined.
Intervention
for the patients with established carotid sinus hypersensitivity: carotid sinus
massage
Study burden and risks
Participation in these studies are safe, with minimal short-term (days)
complications and minimal anticipated long-term risks. The tests (including
preparations) will take up to three hours per subject.
Risks
1. Microneurography. The risks of microneurography (the electrode placed
behind the knee) are some aching sensations and/or parasthesia in the lower
leg, which may last for 2-10 days following the study. The incidence of these
sensations after the study is less than 10% based on a survey of large numbers
of subjects. These sensations are most likely due to some minor swelling at
the electrode site, and heal on their own.
2. Inert gas rebreathing There are no known risks to this procedure.
3. For the patients with established carotid sinus hypersensitivity: carotid
sinus massage bears a risk of 1:1000 of stroke.
Meibergdreef 9
1105AZ Amsterdam
NL
Meibergdreef 9
1105AZ Amsterdam
NL
Listed location countries
Age
Inclusion criteria
60 patients from the departments of Medicine and Cardiology who are being analysed for falls and/or episodes of transient loss of consciousness and for whom there is a clinical indication for carotid sinus massage will be studied.
15 patients from the departments of Medicine and Cardiology with proven carotid sinus hypersensitivity
10 healthy volunteers from general population
Exclusion criteria
- Contra-indications for carotid sinus massage (e.g. carotid bruits recent myocardial or cerebral ischemia, previous ventricular tachyarrhythmias; For the subgroup of 15 patients with established carotid sinus hypersensitivity: cerebrovascular accident or transient ischaemic attack during prior carotid massage)
- presence of any circumstance that is likely to interfere significantly with the use of a tilt table and/or peroneal microneuropgraphy
- for the volunteers: a hierarchical relation to the reaserach group
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL31516.018.10 |