Effectiveness of Artificial Intelligent Based mHealth System to Reduce ACS Patients Bleeding Events After PCI
1 other identifier
interventional
420
1 country
1
Brief Summary
The present study was designed to observe the effectiveness of artificial intelligent based mHealth system(Chronic disease management system) to reduce bleeding events in ACS patients undergoing PCI.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 8, 2018
CompletedStudy Start
First participant enrolled
November 10, 2018
CompletedFirst Posted
Study publicly available on registry
November 13, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2020
CompletedNovember 13, 2018
November 1, 2018
5 months
November 8, 2018
November 8, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
the incidence of major bleeding during each visit between normal group and smartphone based group
Bleeding definition：According to the bleeding Academic Research Congress (BARC) standard
3 months
Study Arms (2)
normal follow-up group
NO INTERVENTIONnormal follow-up in ACS patients after PCI
AI based mHealth system follow-up group
EXPERIMENTALAI based mHealth system follow-up in ACS patients after PCI. ACS patients in this group will receive message to take more notice to bleeding events.
Interventions
AI based mHealth system is used to deliver self-management contral message and health education message to make patients take notice of bleeding events after PCI.
Eligibility Criteria
You may qualify if:
- age≥18 years, male or female; confirmed acute coronary syndrome patients; undergo percutaneous coronary intervention (PCI) treatment; good command of smart phones agree to participate in this clinical study and sign a written consent form.
You may not qualify if:
- ACS admission deemed secondary to other cause such as traffic accidents, trauma, severe upper gastrointestinal bleeding, surgery, or procedure; patients who are not intend to attend 1 year of follow-up study or investigators find that patients are not able to comply with the study's requirements; pregnant women or lactating women; investigators consider patients who were not suitable for participation with other reasons
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The General Hospital of PLA
Beijing, Beijing Municipality, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yundai Chen, Master
The General Hospital of PLA
Central Study Contacts
Yundai Chen, Master
CONTACT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 8, 2018
First Posted
November 13, 2018
Study Start
November 10, 2018
Primary Completion
April 1, 2019
Study Completion
January 1, 2020
Last Updated
November 13, 2018
Record last verified: 2018-11