Acute Myocardial Infarction Complicated With Cardiogenic ShockAMICS-RegNCT07470814
Multidisciplinary Collaborative Care System for Acute Myocardial Infarction Complicated With Cardiogenic Shock
An observational study of Acute Myocardial Infarction Complicated With Cardiogenic Shock, run by Beijing Anzhen Hospital.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myocardial Infarction Complicated With Cardiogenic Shock
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2026to 15 Jul 2029
- How long will I take part?
- 180 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Acute myocardial infarction complicated by cardiogenic shock
Who may be able to join
- 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.
- 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).
- 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.
- Aged ≥ 18 years, of any gender, and able to cooperate with data collection and follow-up (or via a legal guardian).
- 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.
- 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).
Who cannot join
- 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.
- 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).
- 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.
- 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.
- 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.
- Concurrent participation in other similar multicenter clinical studies that may affect data collection, intervention implementation or outcome evaluation of this study.
About this study
Official title: Development and Outcome Evaluation of a Multidisciplinary Collaborative Care System for Acute Myocardial Infarction Complicated With Cardiogenic Shock: A Prospective Multicenter Registry Study (AMI-CS Registry)
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
The primary end point was death from any cause at 180-days
Measured: From enrollment to 180-days
Secondary outcomes (1)
Incidence of Complications
A composite safety end point was severe bleeding, Stroke, Peripheral ischemic vascular complication, hemolysis, Sepsis, device failure
Measured: From enrollment to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start15 Apr 2026 (estimated)
- Primary completion15 Apr 2029 (estimated)
- Study completion15 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial Infarction Complicated With Cardiogenic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 180 Days
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07470814
- Sponsor's protocol ID
- AZ2026369
- Acronym
- AMICS-Reg
- Status last verified
- Feb 2026
- First submitted
- 27 Feb 2026
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Outcome Evaluation of a Multidisciplinary Collaborative Care System for Acute Myocardial Infarction Complicated With Cardiogenic Shock: A Prospective Multicenter Registry Study (AMI-CS Registry)
- ClinicalTrials.gov ID
- NCT07470814
- Acronym / sponsor ID
- AMICS-Reg / AZ2026369
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Study start
- 15 Apr 2026 (estimated)
- Primary completion
- 15 Apr 2029 (estimated)
- Study completion
- 15 Jul 2029 (estimated)
- First posted
- 13 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 180 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Acute myocardial infarction complicated by cardiogenic shock
Key inclusion criteria (6 listed)
- 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.
- 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).
- 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.
- Aged ≥ 18 years, of any gender, and able to cooperate with data collection and follow-up (or via a legal guardian).
- 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.
Key exclusion criteria (6 listed)
- 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.
- 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).
- 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.
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
All-cause mortality
Time frame: From enrollment to 180-days
The primary end point was death from any cause at 180-days
1 secondary outcome
Incidence of Complications
Time frame: From enrollment to 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myocardial Infarction Complicated With Cardiogenic Shock, run by Beijing Anzhen Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: From enrollment to 180-days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.