Digital Out-of-hospital Management on Clinical Outcomes in Patients With Early Cardiogenic Shock: a Multi-center, Randomized Controlled Clinical Trial
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.
• Age ≥ 18 years old;
• The patient meets the diagnosis of early-stage cardiogenic shock, with SCAI stage A, B, or C during hospitalization; (1) SCAI stage A:
⁃ Without signs of shock and meeting one of the following criteria:
• Combined with extensive myocardial infarction, diagnosed as widespread anterior wall myocardial infarction based on ST-segment elevation in ECG leads (V1-V5, aVL, I leads), inferior wall combined with right ventricular (II, III, aVF, V3R-V5R leads) and/or posterior wall myocardial infarction (V7-V9 leads), or recurrent myocardial infarction within 28 days.
• Concurrent acute heart failure or acute exacerbation of chronic heart failure. (2) SCAI stage B-C (meeting the following conditions)
⁃ 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:
• SBP ≥ 90 mmHg when vasoactive drugs are not used;
• No signs and symptoms of shock. 4. Understand and be willing to sign the informed consent, and be willing to follow the treatment and visit plan required by the protocol.