Hong Kong Cardiogenic Shock Initiative (HK CSI)

Acute myocardial infarction complicated by cardiogenic shock (AMI-CS) is a severe condition with high mortality. Early revascularization and Impella device (Abiomed) support improve outcomes. Observational studies like the National Cardiogenic Shock Initiative (NCSI), Inova-Shock registry, and J-PVAD (Japan registry for percutaneous ventricular assist device) registry emphasize the importance of structured care systems when using mechanical circulatory support (MCS).

Following the release of the Danger Shock trial, MCS use is expected to rise. Hospitals will need to monitor practices and work with payers to ensure coverage. Using regional real-world data can assist this process, making the collection and analysis of MCS outcomes essential.

The NCSI (NCT03677180) aimed to evaluate outcomes with a protocolized approach prioritizing rapid diagnosis, timely MCS delivery, and invasive hemodynamic monitoring via pulmonary artery (PA) catheters. The study involved 406 patients from 2016 to 2020, with an average age of 64 years. Most (67%) had shock, with 85% on vasoactive drugs. Witnessed outof-hospital cardiac arrest occurred in 17%, and in-hospital arrest in 30%. During MCS implantation, 9% were actively resuscitating. Patients mostly in SCAI stage C/D (73%) and stage E (27%) presented with low blood pressure, high lactate, and reduced cardiac power output. About 70% received MCS before PCI, with 90% using PA catheters. Most had STEMI, with median door-to-support and door-to-balloon times of about 78 and 81 minutes. Survival rates were high: 99% procedural, 79% to discharge, 77% at 30 days, and 62% at one year for stage C/D shock. Patients with stage E shock had lower survival. Early use of MCS improved hemodynamics and survival. Further research, like the CERAMICS (Can Escalation Reduce Acute Myocardial Infarction in Cardiogenic Shock) study, aims to refine escalation strategies. The Danger Shock trial highlighted the importance of minimizing complications such as bleeding, limb ischemia, haemolysis, and kidney injury.

Currently in Hong Kong, prevalence of CS among AMI patients is 5-10%, in-line with global statistics. Among which, 30-day and 1-year mortality of AMI-CS patients in Hong Kong was reported at 29% and 39.5% respectively. Although the use of MCS has been shown in the above overseas studies to improved survival rates of AMI-CS patients, the utilisation rate of MCS among AMI-CS patients in Hong Kong was reported at 36.5% in a previous single-centre study, limited by an array of factors including limited device availability, allocations of resources and patient selection strategy, lack of region-specific evidence and device affordability. Global Cardiogenic Shock Initiative (GCSI) is an ongoing international multicenter registry involving centers from USA, Germany, and Hong Kong, and focus on the outcomes of AMI-CS patients received Impella support. The GCSI is expanding to many other regions. In the Hong Kong Cardiogenic Shock Initiative (HK-CGSI) study we aim to include sites with experience in MCS, all of whom have the capability of MCS escalation and evaluate outcomes across these centers.

The goal is not only to capture the effects of previously established best practices but gain insights into regional best practices, and together with data from the global cardiogenic shock initiative (GCSI), to better establish the adoption of novel best practices and their effect on complication rates.

In parallel to GCSI-eligible cohort, i.e. Impella used as the first supporting device for patients with AMI-CS, given the significant portion of patients who could not receive MCS under current limitations in Hong Kong, in the HK-CSI, we will include also the GCSI-ineligible cohort, i.e. AMI-CSI without using Impella or not as the first MCS used, to understand the full picture of clinical outcomes of AMI-CS patients of Hong Kong.

The HK-CSI study is an observational registry solely and not a treatment study. This single-arm registry captures data generated during procedures which are considered standard of care. Participation in this registry will be performed with waiver of consent of the patient and will have no influence on the type and extent of treatment.

Study Overview

• Status: Not yet recruiting
• Conditions: Cardiogenic Shock; STEMI - ST Elevation Myocardial Infarction; Mechanical Circulatory Support; Cardiogenic Shock Post Myocardial Infarction; Cardiogenic Shock Acute

• Study Type: Observational
• Enrollment (Estimated): 320

Contacts and Locations

• Study Contact: Name: Kent Chak Yu So; Phone Number: 852-35051518; Email: kentso987@gmail.com

Study Locations

• Hong Kong
  • Shatin
    • Hong Kong, Shatin, Hong Kong, 0000
      • Prince of Wales Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

HKCSI will approximately include 320 cases over 5 years. For subjects in GCSI-eligible cohort (expect n=80), data will be shared with GCSI Study Team and performed together with their Global Database. Analysis of the whole HKCSI cohort will be conducted locally. Study sites will screen all acute myocardial infarction complicated by cardiogenic shock patients, NSTEMI and STEMI, for participation in this trial.

Description

Inclusion Criteria:

• Diagnosis of acute myocardial infarction (AMI) with the ECG and/or biomarker evidence of S-T elevation myocardial infarction (STEMI) or non -S-T elevation myocardial infarction (NSTEMI)

• Cardiogenic Shock is defined as presence of at least two of the following

  1. Hypotension (systolic blood pressure ≤ 100 mmHg, or inotropes/vasopressors to maintain systolic blood pressure ≥ 100 mmHg)
  2. Evidence of end organ perfusion: elevated serum lactate levels (venous or arterial), cool extremities, oliguria/anuria
  3. Hemodynamic criteria represented by cardiac index of <2.2 L/min/m² or a cardiac ≤ 0.6 watts
• Patient is supported with a transvalvular MCS as the initial device (criteria for GCSI-eligible Cohort)
• Patients undergo PCI within 12 hours of hospital presentation (criteria for GCSI-eligible Cohort)
• Subject or legally designated representative (LDR) has provided written informed consent. For patients not able to provide consent, data collection will be conducted in retrospective manner with study consent waived.

Exclusion Criteria:

• Unwitnessed out of hospital cardiac arrest or any cardiac arrest in which return of spontaneous circulation (ROSC) is not achieved within 20 minutes
• Patients demonstrate any signs of anoxic brain injury prior to the INDEX PCI (signs of anoxic injury include, posturing, seizures).
• IABP placed prior to MCS (criteria for GCSI-eligible Cohort)
• Septic, anaphylactic, hemorrhagic, and neurologic causes of shock
• Non-ischemic causes of shock/hypotension (pulmonary embolism, pneumothorax, myocarditis, tamponade, etc.)
• Active bleeding for which MCS in contraindicated
• Recent major surgery for which MCS is contraindicated
• Mechanical complication of AMI (acute ventricular septal defect (VSD) or acute papillary muscle rupture)
• Known left ventricular thrombus for which MCS in contraindicated (criteria for GCSI-eligible Cohort)
• Mechanical aortic prosthetic valve (criteria for GCSI-eligible Cohort)
• Contraindication to intravenous systemic anticoagulation which precludes placement of MCS.

Patients who fulfills all Eligibility Criteria would be recruited and considered GSCI-eligible. AMI-CS patients that did not use MCS, ie. Not fulfiliing both Inclusion Criteria 3, 4, would not be considered screen failure and would still be screened and recruited into HKCSI GCSI-ineligible cohort. Likewise, patients who meet any of Exclusion Criteria will not be GCSI-eligible. Specifically, patients who met exclusion criteria 3, 9, 10 only will be recruited into GCSI-ineligible cohort.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
GSCI-eligible; Cases that need mechanical cardiovascular support and meet all GSCI incluision and exclusion criterias
GSCI-ineligible; All other cases with Cardiogenic shock but do not meet all GSCI incluision and exclusion criterias

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MCS escalation rate during index hospitalisation	MCS escalation rate of AMI-CS patient with use of MCS	Perioperative
1-year mortality	1-year mortality of AMI-CS patient with use of MCS	1-year
1-year mortality	1-year mortality of AMI-CS patient without use of MCS	1-year
30-day mortality	30-day mortality of AMI-CS patient without use of MCS	30-day
30-day mortality	30-day mortality of AMI-CS patient with use of MCS	30-day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
180-day Mortality rate	180-day mortality rate of AMI-CS patient with use of MCS	180-day
180-day Mortality rate	180-day mortality rate of AMI-CS patient without use of MCS	180-day
30-day MCS escalation rate	MCS escalation rate of AMI-CS patient with use of MCS at 30-day	30-day
180-day MCS escalation rate	MCS escalation rate of AMI-CS patient with use of MCS at 30-day	180-day
360-day MCS escalation rate	MCS escalation rate of AMI-CS patient with use of MCS at 30-day	360-day
Rate of In-Hospital Access Site Bleeding	Rate of In-Hospital Access Site Bleeding rated by BARC Bleeding Events during index hospitalization	Perioperative
Rate of acute kidney injury	Acute kidney injury (AKI) per KIDIGO (modified AKIN level >=2) during index hospitalization	Perioperative
Rate of Acute Limb Ischemia	Acute Limb Ischemia requiring fasciotomy and/or amputation during index hospitalization	Perioperative
Lactate level	Lactate Clearance during index hospitalization	Perioperative
Blood Transfusion rate	Rate of Blood Transfusion due to Consumption during index hospitalization	Perioperative
Blood Transfusion rate	Rate of Blood Transfusion due to Hemolysis during index hospitalization	Perioperative
MCS escalation rate	MCS escalation rate of AMI-CS patient with use of MCS During index hospitalisation	Perioperative
MCS escalation rate	MCS escalation rate of AMI-CS patient with use of MCS During index hospitalisation within 12 hours of hemodynamic findings	First 12 hours during index hospitalisation
Rate of MCS re-introduction after removal	Rate of MCS re-introduction after removal in AMI-CS patient with use of MCS	Perioperative until discharge
Access Site Complication rate	Rate of MCS Access Site Complications within 48 hours of MCS removal	within 48 hours of MCS removal
Access Site bleeding rate	Rate of MCS Access Site bleeding within 48 hours of MCS removal	within 48 hours of MCS removal

Collaborators and Investigators

• Sponsor: Prince of Wales Hospital, Shatin, Hong Kong
• Collaborators: Queen Elizabeth Hospital, Hong Kong; Tuen Mun Hospital, Hospital Authority, Hong Koong

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): April 1, 2030
• Study Completion (Estimated): October 2, 2030

Study Registration Dates

• First Submitted: December 3, 2025
• First Submitted That Met QC Criteria: December 28, 2025
• First Posted (Estimated): January 7, 2026

Study Record Updates

• Last Update Posted (Actual): January 9, 2026
• Last Update Submitted That Met QC Criteria: January 7, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Infarction; Necrosis; Myocardial Ischemia; Myocardial Infarction; Ischemia; Shock; Pathological Conditions, Signs and Symptoms; ST Elevation Myocardial Infarction; Shock, Cardiogenic
• Other Study ID Numbers: 2025.671

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No