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This clinical study was a multi-center, open-label, randomized controlled clinical trial. A total of 472 patients with early-stage cardiogenic shock were recruited and randomly divided into the experimental group and the control group, with 236 cases in each group. The HeartMed-HF digital out-of-hospital management was used to manage the patients in the experimental group, while the patients in the control group were managed according to the discharge guidance. The primary endpoints were 1-year all-cause mortality and unplanned readmission after randomization (excluding emergency department visits). Secondary endpoints (at 3 months, 6 months, and 12 months post-randomization) were: all-cause mortality, rehospitalization for HF, recurrent MI, ischemia-driven repeat revascularization, stroke, BARC 3-5 grade major bleeding, unplanned formal rehospitalization, types of GDMT medications or GDMT target dose achievement rate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| conventional management group | No Intervention | ||
| hospital external management | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hospital external management | Combination Product | (I) Symptom management: After enrollment, health managers regularly promoted health education to enhance patients' awareness of the disease and adherence to post-discharge management. Simultaneously, patients were managed via a digital platform, with each patient being provided with a chip-implanted sphygmomanometer to monitor their blood pressure and pulse in real time. If patients develop symptoms, they can report them in real-time and generate alerts to health managers. Through internal clinical decision-making algorithms, the telemedicine team would conduct clinical evaluations and seek decision guidance from clinical cardiologists if necessary. (II) Clinical evaluation: the system stratified patients by risk levels and determined the frequency and intensity of management accordingly, with blood pressure and heart rate monitored daily. The digital management system automatically transmitted abnormal data to a doctor's assistant, with early detection of life-threatening complication |
| Measure | Description | Time Frame |
|---|---|---|
| 1-year all-cause mortality and unplanned formal readmission after randomization (excluding emergency department visits) | From enrollment to the end of management up to 12 months | |
| 1-year all-cause mortality and unplanned formal readmission after randomization (excluding emergency department visits) | Time to first event analysis: Event rates will be estimated by the Kaplan Meier method and compared by the log rank test. Treatment effects will be assessed using Cox regression, with results expressed as hazard ratios (HRs) and 95% CIs. | from enrollment to the end of treatment at 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| all-cause mortality | From enrollment to the end of management up to 12 months | |
| Rehospitalization for HF | From enrollment to the end of management up to 12 months | |
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Inclusion Criteria
Without signs of shock and meeting one of the following criteria:
1) 60 < SBP < 90 mmHg or mean arterial blood pressure 50 < MAP < 60 mmHg or a decrease of > 30 mmHg from baseline lasting 30 minutes; or SBP ≥ 90 mmHg but heart rate /SBP > 1 lasting > 30 minutes.
2) The highest arterial blood lactate during hospitalization < 5 mmol/L. 3. Stable clinical symptoms at discharge, defined as:
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chen jing, doctor | Contact | +86 13659840327 | 364580342@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Renmin Hospital of Wuhan University | Recruiting | Wuhan | Hubei | China |
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| ID | Term |
|---|---|
| D012770 | Shock, Cardiogenic |
| D012769 | Shock |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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Experimental group: digital out-of-hospital management Control group: routine outpatient follow-up
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|
| Recurrent MI |
| From enrollment to the end of management up to 12 months |
| Ischemia-driven repeat revascularization | From enrollment to the end of management up to 12 months |
| Stroke | From enrollment to the end of management up to 12 months |
| Bleeding Academic Research Consortium 3-5 grade | BARC Bleeding Classification • Type 0 No evidence of bleeding. • Type 1 Mild bleeding requiring no medical intervention (e.g., patient self-discontinues medication without seeking medical attention). • Type 2 Overt bleeding necessitating medical intervention (e.g., medication adjustment, hospitalization, or evaluation) but not meeting criteria for higher grades. Examples: Subcutaneous bruising, epistaxis, or minor gastrointestinal bleeding.
CABG-related bleeding (e.g., postoperative reoperation or massive transfusion).
| From enrollment to the end of management up to 12 months |
| Unplanned formal rehospitalization | From enrollment to the end of management up to 12 months |
| Types of GDMT medications | From enrollment to the end of management up to 12 months |
| GDMT target dose achievement rate | From enrollment to the end of management up to 12 months |
| D014652 |
| Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |