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Clinical Trial Summary

BOSS-Trial I is a phase 2 clinical trial with the following objectives;

1. to prove the feasibility of a Bluetooth-equipped sphygmomanometer system in real-world clinical practice and wireless connection to the main server;

2. to prove the feasibility of the BP management strategy, including the pre-specified BP range, BP management algorithm, and behavioral; and

3. to gather information for the phase 3 trial including BP variability indices and their potentials as a treatment guidance.


Clinical Trial Description

- Elevated blood pressure is an established risk factor for recurrent stroke and vascular events in ischemic stroke survivors, but

- Current guideline (JNC VIII) has omitted or only partially covered a number of practical and important issues as follow;

- When and how we measure blood pressure?

- Is it justifiable to apply the same blood pressure threshold for office BP and home BP?

- Should stroke survivors be treated by the same BP goal for non-stroke subjects?

- Is it justifiable to apply the universal BP threshold for different mechanisms of ischemic stroke?

- Is it really about only blood pressure or might it really be "beyond blood pressure?"

- Lifestyle modification should accompany all the pharmacological intervention but is usually in adequate to initiate behavioral changes.

- Frequent BP measurement at home will provide more detailed and reliable information than occasional office BP's. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03024476
Study type Interventional
Source Seoul National University Bundang Hospital
Contact
Status Completed
Phase Phase 2
Start date September 1, 2016
Completion date December 7, 2017

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