SPOKE-HUB SHOCK PROTOCOL MANAGEMENT ACCORDING TO SCAI CLASS IN TURIN AND MILAN AREA
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 786
- 试验地点
- 16
- 主要终点
- Mortality.
研究概览
简要总结
Study Objective To evaluate the impact on 30-day mortality of the adoption of a dedicated cardiogenic shock protocol designed to improve communication and collaboration among centres to timely refer Cardiogenic Shock (CS) patients from spoke to hub centres in Turin and Milan metropolitan Area. Study Design A multicentre, observational, study, consisting of
- retrospective cohort including anonymous data from electronic health records of patients admitted with acute myocardial infarction complicated by cardiogenic shock (AMICS) SCAI class B-D, from Jan 2016 until Dec 2019
- prospective cohort including all consecutive patients admitted for AMICS SCAI class B-D in the study centres Study Population and Centres 768 patients admitted in spoke hospitals for AMICS: 384 in each study cohort. Four centres - two in Milan metropolitan Area and two in Turin - will serve as hub centres, each one receiving CS patients from three referring spoke centres. In total, 16 centres will be involved in the study. Follow-up period Up to 30 days from hospital admission Primary Endpoint The primary endpoint will be the short-term mortality defined as inhospital or 30-day mortality. Secondary Endpoints
- In-hospital or 30-day incidence of:
- stroke, (fatal or non-fatal) or TIA
- bleedings (BARC classification ≥3),
- renal replacement therapy (CVVH / new onset of dialysis)
- vascular complications (all complication needing intervention),
- non-fatal myocardial infarction
- Door-to-support time,
- Onset of symptoms to support time Inclusion criteria Prospective cohort
- For conscious patients, signed and dated informed consent and consent to the processing of personal data
- For unconscious patients, informed consent signed and dated by the legal representative, or a proxy or a relative. The consent will be presented to the patient as soon the health conditions will improve.
- Aging more than 18 years
- Patients admitted within 24h from the diagnosis of AMICS and SCAI SHOCK classification B to D.
CS will be defined as:
- Systolic blood pressure (SBP) < 90 mmHg or mean arterial pressure (MAP) < 60 mmHg, after an appropriate fluid challenge if there is no sign of overt fluid overload, OR need of vasoactive agents to maintain SBP > 90 mmHg or MAP > 60 mmHg, OR need of mechanical cardiac support (MCS);
- At least one of the following criteria/signs of overt hypoperfusion: mixed venous oxygen saturation < 60% arterial lactates > 2 mmol/L; oliguria < 0.5 ml/Kg/h for at least 6 hours.
- CS SCAI B-C-D following an acute myocardial infarction (AMICS) or acute decompensation of heart failure (ADHFCS) Exclusion criteria
- Cardiac arrest with no quantifiable or longer than 10 minutes "no-flow" time or with refractory cardiac arrest (defined as CPR lasting more than 20') 2) Absolute contraindication to mechanical circulatory support devices 3) CS due to other aetiology apart from the ones in inclusion criteria as well as SCAI A and E before device positioning. 4) Age less than 18 years 5) Life expectancy < 1 year due to other reason than cardiogenic shock. Study Timetable Retrospective data collection: Jan 2016 until Dec 2019 Date of first enrolment planned: September 2024 Duration of recruitment: 24 months Follow-up period: 30 days Statistical methods A sample size of 768 patients (384 in each arm) is required to provide the study an 80% power to detect superiority in the primary endpoint with an alpha error set at 0.05 and assuming 30-day mortality estimates of 48% in the pre-protocol group and 38% in group post protocol.
详细描述
Background and rationale Acute myocardial infarction complicated by cardiogenic shock (AMICS) is the leading cause of inhospital mortality in acute myocardial infarctions (AMI), occurs in up to 10% of cases, and is increasingly frequent 2,3. Primary percutaneous coronary intervention (pPCI) is the cornerstone of treatment for AMI complicated by CS (AMICS), and its routine use is associated with a long-term survival benefit4. However, despite innovations in pharmacologic and device-based therapies and systems of care, in-hospital and 30-day mortality in AMICS remain high (50 to 70%) 5. To address this survival plateau, percutaneous mechanical circulatory support devices (pMCS) have been introduced in this clinical setting 6-8. Unfortunately, these technologies are restricted to tertiary hub centres with specific expertise, selection, and management. As a result, shock centres have developed internal protocols to timely manage cardiogenic shock patients. Nevertheless, spoke centres frequently lack dedicated shock protocols for correct and timely management and refer AMICS patients to hub centres, especially in the early phase of the acute presentation. On the other side, a standardized approach to cardiogenic shock performed by a shock team has been demonstrated to have a significant impact on in-hospital and 1-month mortality. The Hub-and-Spoke model is based on the current model for STEMI, trauma, and stroke referral systems9. Studies including patients receiving ECMO and LVADs 10,11 have all demonstrated better outcomes in higher volume facilities. This model can potentially contribute to concentrating resources in each region. The key to the success of the hub and spoke model is the close collaboration between the hub and the spoke centres to develop common protocols and provide training for their effective implementation 12. Recent experiences in the US demonstrated how correct management among Hub and Spoke centres may improve the outcomes of the AMICS patients admitted at Emergency Departments of the spoke centres.
The Spoke and Hub network is a consolidated reality in the Italian sanitary system since the primary PCI networkintroduction for STEMI patients at the end of the 1990s. This approach has been proposed in the last few years also for more complex clinical scenarios, such as cardiogenic shock.
The implementation of a hub and spoke network for the management of cardiogenic shock offers significant advantages as the opportunity to benefit from a specialized shock team and the maximize the implementation of mechanical circulatory support. Having a dedicated multidisciplinary cardiogenic shock team within a referral centre (hub) is crucial. Clinical studies have demonstrated that the timely activation of a multidisciplinary team, including interventional cardiologists, cardiothoracic surgeons, and intensivists, can dramatically reduce mortality associated with this critical condition13. The speed of intervention and the team and expertise in performing life-saving procedures such as pPCI or the implantation and management of ventricular assist devices are determining factors to improve patient survival.
The hub and spoke network also offer the possibility to use more advanced medical therapy and/or mechanical circulatory support and to serve as bridge to recovery or bridge to permanent ventricular assist device or heart transplantation. In fact, patients with cardiogenic shock might benefit from temporary and or permanent ventricular assist devices (VAD). The availability of these devices in hub centres allows for more effective management and continuous monitoring of critically ill patients14.
Timely access to these technologies can significantly increase the chances of hemodynamic stabilization and recovery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All subjects participating in this clinical trial must meet the following criteria:
- •Prospective cohort
- •For conscious patients, signed and dated informed consent and consent to the processing of personal data
- •For unconscious patients, informed consent signed and dated by the legal representative, or a proxy or a relative. The consent will be presented to the patient as soon the health conditions will improve. Aging ≥18
- •CS will be defined as:
- •Systolic blood pressure (SBP) <90 mmHg or mean arterial pressure (MAP) <60 mmHg, after an appropriate fluid challenge if there is no sign of overt fluid overload, OR need of vasoactive agents to maintain SBP > 90 mmHg or MAP > 60 mmHg, OR need of MCS;
- •At least one of the following criteria/signs of overt hypoperfusion: mixed venous oxygen saturation <60%; arterial lactates > 2 mmol/L; oliguria < 0.5 ml/Kg/h for at least 6 hours.
- •CS following an acute myocardial infarction (AMICS) or acute decompensation of heart failure (ADHF-CS)
排除标准
- •Patients will be excluded if any of the following conditions apply:
- •Cardiac arrest with no quantifiable or longer than 10 minutes "no-flow" time or with refractory cardiac arrest (as defined by CPR prolonging for more than 20')
- •Absolute contraindication to support devices.
- •CS due to other aetiology apart from the ones in inclusion criteria as well as SCAI A and E before device positioning.
- •Age greater than 75-year-old
- •Life expectancy < 1 year due to other reason than cardiogenic shock.
结局指标
主要结局
Mortality.
时间窗: 30-days
short-term mortality defined as inhospital or 30-day mortality.
次要结局
- Stroke, (fatal or non-fatal) or TIA(30-days)
- Bleedings (BARC classification ≥3),(30-days)
- Renal replacement therapy(30-days)
- Vascular complications(30-days)
- Non-fatal myocardial infarction(30-days)
- Door-to-support time(30-days)
- Onset of symptoms to support time(30-days)