Actively Recruiting
Digital Out-of-hospital Management on Clinical Outcomes in Patients With Early Cardiogenic Shock: a Multi-center, Randomized Controlled Clinical Trial
Led by Renmin Hospital of Wuhan University · Updated on 2025-07-25
472
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating how digital out-of-hospital management impacts patients with early-stage cardiogenic shock. This multi-center, open-label, randomized controlled trial aims to compare the effects of a digital management system with conventional discharge guidance on important clinical outcomes. The study focuses on patients diagnosed with early cardiogenic shock at SCAI stages A, B, or C, assessing death and hospital readmissions over one year. The experimental group receives hospital external management through a digital platform that includes a chip-implanted sphygmomanometer for real-time blood pressure and pulse monitoring. Health managers provide ongoing education and symptom management, while a telemedicine team evaluates clinical data daily and alerts cardiologists as needed. The control group follows standard discharge guidance without this digital monitoring. Management and follow-up occur over 12 months. Participants are monitored for one year after enrollment with assessments including mortality, hospital readmissions, heart failure rehospitalization, recurrent heart attacks, stroke, serious bleeding events, and medication use related to guideline-directed medical therapy. The digital system tracks vital signs and symptoms daily, and researchers evaluate the achievement of medication targets and unplanned hospital visits. This comprehensive monitoring aims to improve early detection and management of complications.
CONDITIONS
Brief Title
Digital Out-of-hospital Management on Clinical Outcomes in Patients With Early Cardiogenic Shock
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosed with early-stage cardiogenic shock, SCAI stage A, B, or C during hospitalization
- Stable clinical symptoms at discharge, including systolic blood pressure ≥ 90 mmHg without vasoactive drugs and no signs of shock
- Able to understand and willing to sign informed consent
- Willing to follow the treatment and visit plan required by the protocol
You will not qualify if you...
- Unable to use a smartphone for out-of-hospital management despite training
- Discharged due to treatment withdrawal or transfer to another hospital
- Previous or current hospital admission due to cardiac arrest
- Refractory cardiogenic shock
- Refractory heart failure (Stage D according to ACC/AHA guidelines)
- Left ventricular ejection fraction less than 30%
- Estimated glomerular filtration rate less than 25 ml/min or on dialysis
- Severe liver insufficiency (Child-Pugh class C)
- Severe chronic obstructive pulmonary disease
- History of cardiac surgery
- Pregnant or lactating women
- Malignant tumors or serious diseases with expected life span less than 1 year
- Neuropsychiatric disorders preventing cooperation
- Participation in other clinical trials within the past year
- Other conditions deemed inappropriate by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months
Participants receive hospital external management involving symptom management through a digital platform, daily monitoring of blood pressure and heart rate via chip-implanted devices, and clinical evaluation with risk stratification and telemedicine support.
Regular digital monitoring with daily vital sign checks and symptom reporting; visits as needed based on clinical evaluation
Duration - Up to 12 months post-enrollment
Participants are monitored for clinical outcomes including mortality and rehospitalization after the treatment period ends.
Follow-up assessments as scheduled up to 12 months
Trial Site Locations
Total: 1 location
1
Renmin Hospital of Wuhan University
Wuhan, Hubei, China
Actively Recruiting
Research Team
C
Chen jing, doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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