Effectiveness of the Application(APP) on Individualized Antithrombotic Therapy (APP)
Effectiveness of the Application on Individualized Antithrombotic Therapy in Chinese Patients With Coronary Artery Disease
調査の概要
詳細な説明
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.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
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Guangdong
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Guangzhou、Guangdong、中国
- 募集
- Guangdong General Hospital
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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)
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:なし
- 介入モデル:単一グループの割り当て
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
実験的: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.
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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.
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
adverse clinical events
時間枠:2 years
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net adverse clinical events during 2 years follow-up, including death, myocardial infarction, stroke, ischemia induced target vessel revascularization, BARC type 2-5 bleeding
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2 years
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BRAC 2-5 type bleeding
時間枠:2 years
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defined as bleeding event graded 2 to 5 of Standardized bleeding definitions from the Bleeding Academic Research Consortium(BRAC)
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2 years
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
heart and cerebral vessels ischemia
時間枠:2 years
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adeverse events of vascular death, myocardial infarction and stroke
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2 years
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readmission
時間枠:2 years
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incidence of readmission during 2-year follow-up
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2 years
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angina recurrence
時間枠:2 years
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incidence of angina recurrence during 2-year follow-up
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2 years
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treatment discontinuation
時間枠:2 years
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incidence of treatment discontinuation during 2-year follow-up
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2 years
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drug-related events
時間枠:2 years
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incidence of drug-related adverse reaction during 2-year follow-up
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2 years
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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