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Home blood pressure monitoring in patients after carotid endarterectomy: a feasibility study

Home blood pressure monitoring in patients after carotid endarterectomy: a feasibility study - Home blood pressure monitoring after CEA

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON45630
Enrollment
30
Registered
2017-07-26
Start date
2017-10-11
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

arterial plaques hardening of arteries

Interventions

blood pressure
Carotid endarterectomy

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - Adult (>=18 yr of age) - (a)symptomatic carotid artery stenosis due to atherosclerotic disease - Treated by carotid endarterectomy - mentally capable to make discissions

Exclusion criteria

Exclusion criteria: - ADL-dependent due to prior TIA or cerebrovascular accident (not able to measure the blood pressure twice a day) - ADL-dependent because of other reasons besides above mentioned reason. - Patients with carotid artery stenosis caused by other causes then atherosclerotic disease - not mentally capable

Design outcomes

Primary

MeasureTime frame
The primary objective of this study is the feasibility, to assess the patient*s experience regarding performing home blood pressure measurements themselves and the use of cVitals in the first month after carotid endarterectomy. Patients experience will be assessed by means of a telephone survey based on a predefined questionnaire.

Secondary

MeasureTime frame
The secondary objective, is the time from the start of the study to the appearance of a period of consecutive high blood pressure values who will exceed the predefined systolic threshold during the first month after hospital discharge after carotid endarterectomy and measured by the patients themselves. This predefined blood systolic threshold is based on the last performed Transcranial Doppler postoperative. Primary outcome is tIn case of a period of consecutive high blood pressure values who will exceed this predefined systolic threshold, will be requested to come to the outpatient clinic or emergency room for check-up of blood pressure. Other outcomes are: • The number of patients in which a significant change in blood pressure is measured during the first month at home compared to the last performed blood pressure measurement in the hospital. • The number of patients in which (early) signals of cerebral hyperperfusion are notified; • The number of patients in which treatment needs to change based on the home blood pressure measurements; • The number of alarms (patient-specific; which could be set prior to hospital discharge) that are correctly issued; • The correlation of the post-operative measured blood pressure measurements with the change in blood pressure rate (trend) measurements at one month. • Percentage of patient adherence (number of actively sent blood pressure measurements divided by the number of measurements requested for the study, twice a day during 30 days.)

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)