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

March 12, 2026 updated by: Beijing Anzhen Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Acute myocardial infarction complicated by cardiogenic shock

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
All-cause mortality
Time Frame: From enrollment to 180-days
The primary end point was death from any cause at 180-days
From enrollment to 180-days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of Complications
Time Frame: From enrollment to 30 days
A composite safety end point was severe bleeding, Stroke, Peripheral ischemic vascular complication, hemolysis, Sepsis, device failure
From enrollment to 30 days

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Poor neurological outcome in survivors questionnaire
Time Frame: From enrollment to 180 days
From enrollment to 180 days
Length of intensive care treatment
Time Frame: From enrollment to 180 days
Length of intensive care treatment (days)
From enrollment to 180 days
Length of hospital stay (days)
Time Frame: From enrollment to 180 days
Length of hospital stay (days)
From enrollment to 180 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Beijing Anzhen Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 15, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 15, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 15, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 27, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 13, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AZ2026369

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings