Effectiveness of the Application(APP) on Individualized Antithrombotic Therapy

NCT ID: NCT03454854

Last Updated: 2018-05-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-01

Study Completion Date

2020-12-20

Brief Summary

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Develop an exemplary anti-thrombotic therapy network data platform and a intelligent terminal application(APP), establish an new pattern used in long-time anti-thrombotic management based on dynamic risk evaluation, and promoted and verified by 10 thousands large sample's cohort study.

Detailed Description

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1.1.Develop and optimize antithrombotic therapy network data platform and thrombotic risk evaluate the intelligent terminal APP, establish a new pattern based on dynamic risk evaluation and event-triggered response, settle the conundrum in clinical practice about antithrombotic therapy such as poor compliance, lag and unreasonable in drug adjustment.

1.2.Settle the technical problem that intelligent terminal APP code isn't compatible with most tablet PCs and smartphones.

1.3.Impel the data platform to render and integrate with the daily medical system, enhance its accuracy, compatibility, privacy, and quality standard.

1.4.Promote the new pattern of anti-thrombotic management by large sample's cohort study, increase the patients' compliance, reduce the readmission rate and adverse event rate of heart and cerebral vessels.

Conditions

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Antithrombotic

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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APP-assisted anti-thrombotic therapy

Intelligent response system:real-time receiving data or events that doctor or patient terminal upload,then spontaneously evaluate the thrombosis and bleeding risk based on code of point built-in,respectively send messages to doctor and patient after this, then doctors direct the patients to adjust treatment schedule.Develop an exemplary anti-thrombotic therapy network data platform and a intelligent terminal APP, establish an new pattern used in long-time anti-thrombotic management based on dynamic risk evaluation, and promoted and verified by 10 thousands large sample's cohort study.

Group Type EXPERIMENTAL

intelligent terminal APP

Intervention Type DEVICE

Applications(APP) support patients to upload the primary data contain pictures and wearable devices data. When risk-rating changes or serious adverse events(SAE) take place, APP will alert patients to seek medical advice or make a call with the doctor. Beside, terminal of patients furnishes functions like answering frequently asked questions,self-assessment of physical condition,push rehabilitation knowledge etc.

Interventions

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intelligent terminal APP

Applications(APP) support patients to upload the primary data contain pictures and wearable devices data. When risk-rating changes or serious adverse events(SAE) take place, APP will alert patients to seek medical advice or make a call with the doctor. Beside, terminal of patients furnishes functions like answering frequently asked questions,self-assessment of physical condition,push rehabilitation knowledge etc.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* age≄18 years;
* clinical confirmed coronary heart disease. Including definite history of myocardial infarction, stable angina with exercise electrocardiography test(treadmill exercise) positive, unstable angina with electrocardiogram(ECG) ischemic changes or troponin positive, coronary angiography(CAG) hints at least one coronary artery stenoses over 50%, post-operative of percutaneous coronary intervention(PCI) or coronary artery bypass grafting(CABG);
* Be receiving anti-thrombotic therapy;
* Be voluntary to participate in the study., and sign informed consent form.

Exclusion Criteria

* inability to obtain consent from participants;
* unable to record the medical data through terminal applications(APP)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guangdong Provincial People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jiyan Chen

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jiyan Chen, M.D.

Role: PRINCIPAL_INVESTIGATOR

Guangdong Provincial People's Hospital

Locations

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Guangdong General Hospital

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jiyan Chen, M.D.

Role: CONTACT

02083827812

Facility Contacts

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Jiyan Chen, M.D.

Role: primary

02083827812

Other Identifiers

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GDCR2017144H

Identifier Type: -

Identifier Source: org_study_id

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