Digital Out-of-hospital Management on Clinical Outcomes in Patients With Early Cardiogenic Shock: a Multi-center, Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 472
- 试验地点
- 1
- 主要终点
- 1-year all-cause mortality and unplanned formal readmission after randomization (excluding emergency department visits)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •Stable clinical symptoms at discharge, defined as:
- •SBP ≥ 90 mmHg when vasoactive drugs are not used;
- •No signs and symptoms of shock.
- •Understand and be willing to sign the informed consent, and be willing to follow the treatment and visit plan required by the protocol.
排除标准
- •Unable to use a smartphone for out-of-hospital management despite training
- •The reasons for discharge were treatment withdrawal and transfer to another hospital for continued therapy
- •Previous or current hospital admission due to cardiac arrest
- •Refractory cardiogenic shock
- •Refractory Heart Failure (ACC/AHA guidelines Stage D heart Failure)
- •Left ventricular ejection fraction < 30%
- •(Estimated) glomerular filtration rate < 25 ml/min or on dialysis
- •Severe hepatic insufficiency (Child-Pugh class C)
- •Severe chronic obstructive pulmonary disease (confirmed by pulmonary function tests, or requiring long-term home oxygen therapy or long-term use of corticosteroids)
- •History of cardiac surgery
- •Pregnant or lactating women
- •Combined with malignant tumors and other serious diseases, the expected life span is less than 1 year
- •Neuropsychiatric disorders, unable to cooperate with management;
- •Participation in other clinical trials within the past year;
- •Other circumstances considered to be inappropriate for this study by the investigator.
研究组 & 干预措施
hospital external management
干预措施: hospital external management (Combination Product)
conventional management group
结局指标
主要结局
1-year all-cause mortality and unplanned formal readmission after randomization (excluding emergency department visits)
时间窗: From enrollment to the end of management up to 12 months
次要结局
- 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)
- 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(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)
研究者
Chen Jing
Chief of Cardiology Department
Renmin Hospital of Wuhan University