Back to resultsEffectiveness of Artificial Intelligent Based mHealth System to Reduce ACS Patients Bleeding Events After PCI
Primary Purpose
Acute Coronary Syndrome, Percutaneous Coronary Intervention, Bleeding
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
AI based mHealth system
Sponsored by
About this trial
This is an interventional prevention trial for Acute Coronary Syndrome focused on measuring Acute Coronary Syndrome, Percutaneous coronary intervention, Bleeding
Eligibility Criteria
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
Sites / Locations
- The General Hospital of PLARecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
normal follow-up group
AI based mHealth system follow-up group
Arm Description
normal follow-up in ACS patients after PCI
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT03738930
First Posted
November 8, 2018
Last Updated
November 8, 2018
Sponsor
Chinese PLA General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03738930
Brief Title
Effectiveness of Artificial Intelligent Based mHealth System to Reduce ACS Patients Bleeding Events After PCI
Official Title
Effectiveness of Artificial Intelligent Based mHealth System(Chronic Disease Management System) to Reduce ACS Patients Bleeding Events After PCI: Parallel Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 10, 2018 (Anticipated)
Primary Completion Date
April 1, 2019 (Anticipated)
Study Completion Date
January 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese PLA General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome, Percutaneous Coronary Intervention, Bleeding
Keywords
Acute Coronary Syndrome, Percutaneous coronary intervention, Bleeding
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
420 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
normal follow-up group
Arm Type
No Intervention
Arm Description
normal follow-up in ACS patients after PCI
Arm Title
AI based mHealth system follow-up group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
AI based mHealth system
Intervention Description
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.
Primary Outcome Measure Information:
Title
the incidence of major bleeding during each visit between normal group and smartphone based group
Description
Bleeding definition：According to the bleeding Academic Research Congress (BARC) standard
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dandan Li, Master
Phone
+86 15711017209
Email
cardio_lidandan@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yundai Chen, Master
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yundai Chen, Master
Organizational Affiliation
The General Hospital of PLA
Official's Role
Principal Investigator
Facility Information:
Facility Name
The General Hospital of PLA
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dandan Li, Master
Phone
+86 15711017209
Email
cardio_lidandan@163.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Effectiveness of Artificial Intelligent Based mHealth System to Reduce ACS Patients Bleeding Events After PCI
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