- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03738930
Effectiveness of Artificial Intelligent Based mHealth System to Reduce ACS Patients Bleeding Events After PCI
Effectiveness of Artificial Intelligent Based mHealth System(Chronic Disease Management System) to Reduce ACS Patients Bleeding Events After PCI: Parallel Randomized Controlled Trial
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Dandan Li, Master
- Phone Number: +86 15711017209
- Email: cardio_lidandan@163.com
Study Contact Backup
- Name: Yundai Chen, Master
Study Locations
-
-
Beijing
-
Beijing, Beijing, China
- Recruiting
- The General Hospital of PLA
-
Contact:
- Dandan Li, Master
- Phone Number: +86 15711017209
- Email: cardio_lidandan@163.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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.
Exclusion Criteria:
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: normal follow-up group
normal follow-up in ACS patients after PCI
|
|
Experimental: AI based mHealth system follow-up group
AI 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the incidence of major bleeding during each visit between normal group and smartphone based group
Time Frame: 3 months
|
Bleeding definition:According to the bleeding Academic Research Congress (BARC) standard
|
3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Yundai Chen, Master, The General Hospital of PLA
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AI-mHealth-pilot
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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