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NCT03738930 Clinical Trial

Effectiveness of Artificial Intelligent Based mHealth System to Reduce ACS Patients Bleeding Events After PCI

Acute Coronary Syndrome Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03738930
Other study ID # AI-mHealth-pilot
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 10, 2018
Est. completion date January 1, 2020

Study information
Verified date November 2018
Source Chinese PLA General Hospital
Contact Dandan Li, Master
Phone +86 15711017209
Email cardio_lidandan@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 420
Est. completion date January 1, 2020
Est. primary completion date April 1, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• AI based mHealth system
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.

Locations
Country Name City State
China The General Hospital of PLA Beijing Beijing

Sponsors (1)
Lead Sponsor Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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