Multidisciplinary Collaborative Care System for Acute Myocardial Infarction Complicated With Cardiogenic Shock (AMICS-Reg)

Capital Medical University

Status: Begins enrollment this month

Conditions: Acute Myocardial Infarction Complicated With Cardiogenic Shock

Study type: Observational

Funder types: Other

Identifiers

NCT07470814

AZ2026369

Details and patient eligibility

About

Acute myocardial infarction complicated by cardiogenic shock (AMI-CS) represents the most life-threatening subtype of acute cardiovascular diseases. Current clinical management of AMI-CS in China is plagued by multiple structural challenges, including a rapidly aging patient population, inequitable distribution of medical resources, the absence of standardized care models, and poor applicability of international risk stratification tools. Owing to ethnic disparities in disease presentation and the low penetration of mechanical circulatory support (MCS) devices in China, international clinical evidence for AMI-CS diagnosis and treatment cannot be directly translated into local clinical practice. Furthermore, the lack of a standardized multidisciplinary collaborative care system has become a critical bottleneck hindering the reduction of AMI-CS mortality. To address these unmet clinical needs, this study aims to develop a tailored multidisciplinary collaborative care system adapted to China's healthcare landscape and to evaluate its clinical efficacy and safety via a prospective multicenter registry study. The study will establish a tiered collaborative network encompassing healthcare institutions of all levels and formulate standardized clinical pathways and risk stratification strategies for AMI-CS. A total of at least 1,000 AMI-CS patients will be enrolled in the study, with systematic collection of their clinical characteristics, multidisciplinary interventions, MCS utilization, and prognostic outcomes to build a high-quality real-world database. Based on the registry data, a China-specific risk stratification model for AMI-CS will be developed by integrating clinical metrics, biomarkers, and imaging features. This study will assess the benefits and risks of MCS devices used alone or in combination, and evaluate the implementation effectiveness of the multidisciplinary collaborative care system by comparing core outcomes-including 30/180-day all-cause mortality, severe complication rates, and door-to-balloon times-before and after the system's rollout and across healthcare institutions of different tiers. Additionally, this study will explore the key factors influencing the efficacy of multidisciplinary collaboration to inform the optimization of the care system. This study is expected to validate the feasibility and effectiveness of the multidisciplinary collaborative care system in the Chinese clinical setting, reduce AMI-CS mortality, narrow the gap in care capacity across different-tier hospitals, and fill the evidence gap in multidisciplinary AMI-CS management for the Chinese population.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Meets the diagnostic criteria for acute myocardial infarction (AMI): presents with typical myocardial ischemic symptoms (e.g., chest pain, chest tightness, dyspnea), or asymptomatic with electrocardiographic changes indicative of ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI), accompanied by elevated myocardial injury markers such as troponin and creatine kinase-MB (CK-MB). Conforms to the Fourth Universal Definition of Myocardial Infarction and the relevant diagnostic criteria in the Chinese Guidelines for the Diagnosis and Treatment of Acute ST-Segment Elevation Myocardial Infarction and Chinese Guidelines for the Diagnosis and Treatment of Non-ST-Segment Elevation Acute Coronary Syndromes.
2. Complicated with cardiogenic shock (CS): meets the dual definition of CS in the SHARC Consensus, i.e., hemodynamic criteria (systolic blood pressure < 90 mmHg for ≥ 30 minutes, or systolic blood pressure ≥ 90 mmHg maintained only with vasoactive agents/mechanical circulatory support) **plus at least one** sign of tissue hypoperfusion: lactate > 2 mmol/L, cold/mottled skin, altered mental status (lethargy, stupor, coma), or oliguria (urine output < 0.5 ml·kg-¹·h-¹ for ≥ 1 hour).
3. Time from symptom onset to hospital admission ≤ 12 hours, meeting the intervention time window of the multidisciplinary collaborative care system, with complete clinical data collectible for the entire diagnosis and treatment process.
4. Aged ≥ 18 years, of any gender, and able to cooperate with data collection and follow-up (or via a legal guardian).
5. Voluntarily participates in the study, signs a written informed consent form, and agrees to complete the full follow-up and the collection, collation and analysis of relevant data.
6. Seeks medical care at the designated study centers of all levels and is able to receive the standardized multidisciplinary collaborative interventions formulated in this study (no mandatory requirement for specific MCS device therapy; treatment follows clinical actual practice).

Exclusion criteria

1. Cardiogenic shock of non-myocardial infarction etiology: including other cardiovascular diseases such as severe heart failure, myocarditis, cardiomyopathy, aortic dissection, pulmonary embolism, and severe arrhythmias; or non-cardiogenic shock such as septic shock, hemorrhagic shock, and anaphylactic shock.
2. Patients with end-stage organ disease: e.g., end-stage heart failure (NYHA Class Ⅳ and irreversible), end-stage renal disease (long-term dialysis required with an estimated survival < 1 year), end-stage liver disease (decompensated cirrhosis with severe complications), and advanced malignant tumors (estimated survival < 1 year).
3. With definite contraindications to multidisciplinary collaborative care: unable to tolerate revascularization therapy, unable to cooperate with multidisciplinary consultation and relevant examinations, or refusing necessary diagnostic and therapeutic interventions.
4. Severe incompleteness of clinical data, or refusal to participate in follow-up/failure to complete ≥ 30-day follow-up with an extremely high estimated loss-to-follow-up risk.
5. Complicated with severe mental illness or cognitive impairment, or involved in legal disputes with inability to sign the informed consent form and no eligible legal guardian to sign on their behalf.
6. Concurrent participation in other similar multicenter clinical studies that may affect data collection, intervention implementation or outcome evaluation of this study.