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National Cardiogenic Shock Initiative

National Cardiogenic Shock Initiative

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03677180
Acronym
NCSI
Enrollment
406
Registered
2018-09-19
Start date
2016-05-19
Completion date
2020-12-31
Last updated
2025-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myocardial Infarction, Cardiogenic Shock, Heart Attack, NSTEMI - Non-ST Segment Elevation MI, STEMI - ST Elevation Myocardial Infarction

Keywords

Cardiogenic shock, Mechanical circulatory support, National Cardiogenic Shock Initiative, Myocardial infarction, Heart attack, Acute MI, NCSI, National CSI, Impella, Shock, Hemodynamic Support

Brief summary

This study evaluates the use of early mechanical circulatory support in patients presenting with acute myocardial infarction and cardiogenic shock. Patients are treated according to the National Cardiogenic Shock Initiative protocol, which emphasizes early identification of cardiogenic shock and rapid delivery of mechanical circulatory support based on invasive hemodynamics. All patients treated in this manner are enrolled in the National Cardiogenic Shock registry.

Detailed description

Acute myocardial infarction complicated by cardiogenic shock (AMICS) is a deadly condition with a historical in-hospital survival of only 50%. To date, the only therapy proven to benefit patients in AMICS using data from randomized control trials has been early mechanical reperfusion. Accordingly, current American and European guidelines confer a class IB indication for reperfusion therapy in the setting of AMICS. Unfortunately, little progress has been made on improving survival with subsequent therapies, including intra-aortic balloon pump counter-pulsation (IABP). This lack of progress is worrisome since the incidence of AMICS appears to be increasing. With the FDA approval of Impella (Abiomed, Danvers, MA) in AMICS, a powerful new tool has become available for hemodynamic support. Impella is a transcatheter axial flow pump, delivered percutaneous, with the ability to provide 2.5 to 4.0 liters/minute of forward flow. The device should provide sufficient forward cardiac flow to support vital organs in the majority of patients who present with AMICS. Since Impella is the only percutaneous temporary ventricular support device approved as safe and effective for use in AMICS, the use of the device has steadily grown. Unfortunately, there is little data available to providers as to the best practice patterns associated with the delivery and use of Impella in AMICS. Using the most up-to-date research, a treatment algorithm for AMICS was developed and subsequently implemented as a quality improvement initiative throughout southeast Michigan. Patient information was gathered by each of the sites and collected in a retrospective registry. Outcomes and results were shared during quarterly meetings and concluded with a 41-patient pilot feasibility study. This initial pilot study revealed a 76% survival to discharge, a significant improvement compared to prior historical controls. Given the promising outcomes, leaders from around the world have implemented the treatment algorithm in their local clinical practices with similar results. The investigators have therefore launched the National Cardiogenic Shock Initiative (NCSI). The aim of the NCSI is to bring together experienced centers across the nation who are experts in mechanical reperfusion therapies and have a large experience with the use of mechanical circulatory support devices to systematize care in AMICS. Our goal is to dramatically decrease the duration patients remain in cardiogenic shock and attempt to decrease total usage and duration of vasopressors and ionotropic agents. The investigators aim to further demonstrate that rapid delivery of mechanical circulatory support will improve hemodynamics, reverse the spiraling neuro-hormonal cascade associated with cardiogenic shock, allowing clinicians to decrease use of vasopressors and inotropic agents and ultimately improve survival. Healthcare systems that have agreed to adopt the NCSI treatment algorithm are being asked to participate in this prospective registry so that patient outcomes can be analyzed. Participating investigators will be asked to voluntarily provide data from patients completing the treatment algorithm to be included in the NCSI Registry.

Interventions

None listed

Sponsors

Abiomed Inc.
CollaboratorINDUSTRY
Chiesi Farmaceutici S.p.A.
CollaboratorINDUSTRY
Henry Ford Health System
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Registry Inclusion Criteria: 1. Symptoms of acute myocardial infarction (AMI) with ECG and/or biomarker evidence of S-T elevation myocardial infarction (STEMI) or non-S-T elevation myocardial infarction (NSTEMI) 2. Cardiogenic shock is defined as the presence of at least two of the following: 1. Hypotension (systolic blood pressure ≤90 mm Hg, or inotropes/vasopressors to maintain systolic blood pressure ≥90 mmHg) 2. Signs of end organ hypoperfusion (cool extremities, oliguria or anuria, or elevated lactate levels) 3. Hemodynamic criteria represented by a cardiac index of \<2.2 L/min/m2 or a cardiac power output ≤0.6 watts. 3. Patient is supported with an Impella 4. Patient undergoes PCI Registry

Exclusion criteria

1. Evidence of Anoxic Brain Injury 2. Unwitnessed out of hospital cardiac arrest or any cardiac arrest in which return of spontaneous circulation (ROSC) is not achieved within 30 minutes 3. IABP placed prior to Impella 4. Septic, anaphylactic, hemorrhagic, and neurologic causes of shock 5. Non-ischemic causes of shock/hypotension (pulmonary embolism, pneumothorax, myocarditis, tamponade, etc.) 6. Active bleeding for which mechanical circulatory support is contraindicated 7. Recent major surgery for which mechanical circulatory support is contraindicated 8. Mechanical complications of AMI (acute ventricular septal defect (VSD) or acute papillary muscle rupture) 9. Known left ventricular thrombus for which mechanical circulatory support is contraindicated 10. Mechanical aortic prosthetic valve 11. Contraindication to intravenous systemic anticoagulation

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants Who Survived at Dischargethrough study completion (hospital discharge), an average of 30 days.Number of Participants Who Survived at Discharge

Secondary

MeasureTime frameDescription
Number of Participants Who Survived to 30 Days Post Hospital Discharge.30 days post-hospital discharge.Number of Participants Who Survived to 30 Days Post Hospital Discharge.
Number of Participants Who Survived to 1 Year Post Hospital Discharge.1 yearNumber of Participants Who Survived to 1 Year Post Hospital Discharge.

Other

MeasureTime frameDescription
Number of Vasopressors & Inotropes UsedPrior to start of mechanical circulatory support during PCI (pre-PCI), post-PCI, 12-hours post-PCI, 24-hours post-PCINumber of vasopressor & inotropic medications being administered in patients being treated with early MCS (mechanical circulatory support) during percutaneous coronary intervention (PCI) treatment for AMICS (acute myocardial infarction with cardiogenic shock).
Use of MCS Pre-PCIAt index Cath Lab procedure/PCI (percutaneous coronary intervention)Number of patients who receive mechanical circulatory support (MCS) pre-PCI (percutaneous coronary intervention).
Average Cardiac Power Output (CPO) Measurements at Index PCI (Percutaneous Coronary Intervention), Post-PCI, 12 Hours Post-PCI, 24 Hours Post-PCIAt index PCI (percutaneous coronary intervention), post-PCI, 12-hours post-PCI, 24-hours post-PCIAbility to maintain a cardiac power output (CPO) measurement of \> 0.6 watts.
Door to Support Time < 90 MinutesAt index Cath Lab procedure/PCI (percutaneous coronary intervention)This outcome measures the time from the patient's arrival to the hospital to the time that MCS (mechanical circulatory support) was started and whether this was greater than or less than 90 minutes.
Number of Participants With Establishment of TIMI III Coronary Blood FlowAt index Cath Lab procedure/PCI (percutaneous coronary intervention).Establishment of TIMI III (thrombolysis in myocardial infarction) coronary blood flow during index PCI (percutaneous coronary intervention) in culprit lesions.

Countries

United States

Participant flow

Participants by arm

ArmCount
Acute Myocardial Infarction (STEMI or NSTEMI) With Cardiogenic Shock
Patients who presented to the hospital with an acute MI (STEMI or NSTEMI) and in cardiogenic shock (by protocol definition) prior to percutaneous coronary intervention (PCI).
406
Total406

Baseline characteristics

CharacteristicAcute Myocardial Infarction (STEMI or NSTEMI) With Cardiogenic Shock
Age, Continuous63.7 Years
STANDARD_DEVIATION 12.3
Race/Ethnicity, Customized
Black
34 Participants
Race/Ethnicity, Customized
Hispanic
28 Participants
Race/Ethnicity, Customized
Other
30 Participants
Race/Ethnicity, Customized
Patient refused to reveal or information not available
37 Participants
Race/Ethnicity, Customized
White
277 Participants
Sex: Female, Male
Female
96 Participants
Sex: Female, Male
Male
310 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
152 / 406
other
Total, other adverse events
0 / 0
serious
Total, serious adverse events
83 / 365

Outcome results

Primary

Number of Participants Who Survived at Discharge

Number of Participants Who Survived at Discharge

Time frame: through study completion (hospital discharge), an average of 30 days.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Acute Myocardial Infarction (STEMI or NSTEMI) With Cardiogenic ShockNumber of Participants Who Survived at Discharge287 Participants
Secondary

Number of Participants Who Survived to 1 Year Post Hospital Discharge.

Number of Participants Who Survived to 1 Year Post Hospital Discharge.

Time frame: 1 year

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Acute Myocardial Infarction (STEMI or NSTEMI) With Cardiogenic ShockNumber of Participants Who Survived to 1 Year Post Hospital Discharge.173 Participants
Secondary

Number of Participants Who Survived to 30 Days Post Hospital Discharge.

Number of Participants Who Survived to 30 Days Post Hospital Discharge.

Time frame: 30 days post-hospital discharge.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Acute Myocardial Infarction (STEMI or NSTEMI) With Cardiogenic ShockNumber of Participants Who Survived to 30 Days Post Hospital Discharge.272 Participants
Other Pre-specified

Average Cardiac Power Output (CPO) Measurements at Index PCI (Percutaneous Coronary Intervention), Post-PCI, 12 Hours Post-PCI, 24 Hours Post-PCI

Ability to maintain a cardiac power output (CPO) measurement of \> 0.6 watts.

Time frame: At index PCI (percutaneous coronary intervention), post-PCI, 12-hours post-PCI, 24-hours post-PCI

ArmMeasureGroupValue (MEAN)Dispersion
Acute Myocardial Infarction (STEMI or NSTEMI) With Cardiogenic ShockAverage Cardiac Power Output (CPO) Measurements at Index PCI (Percutaneous Coronary Intervention), Post-PCI, 12 Hours Post-PCI, 24 Hours Post-PCICPO pre-PCI0.67 Watts (W)Standard Deviation 0.29
Acute Myocardial Infarction (STEMI or NSTEMI) With Cardiogenic ShockAverage Cardiac Power Output (CPO) Measurements at Index PCI (Percutaneous Coronary Intervention), Post-PCI, 12 Hours Post-PCI, 24 Hours Post-PCICPO post-PCI0.88 Watts (W)Standard Deviation 0.44
Acute Myocardial Infarction (STEMI or NSTEMI) With Cardiogenic ShockAverage Cardiac Power Output (CPO) Measurements at Index PCI (Percutaneous Coronary Intervention), Post-PCI, 12 Hours Post-PCI, 24 Hours Post-PCICPO 12-hours post-PCI0.83 Watts (W)Standard Deviation 0.34
Acute Myocardial Infarction (STEMI or NSTEMI) With Cardiogenic ShockAverage Cardiac Power Output (CPO) Measurements at Index PCI (Percutaneous Coronary Intervention), Post-PCI, 12 Hours Post-PCI, 24 Hours Post-PCICPO 24-hours post-PCI0.98 Watts (W)Standard Deviation 1.32
Other Pre-specified

Door to Support Time < 90 Minutes

This outcome measures the time from the patient's arrival to the hospital to the time that MCS (mechanical circulatory support) was started and whether this was greater than or less than 90 minutes.

Time frame: At index Cath Lab procedure/PCI (percutaneous coronary intervention)

ArmMeasureValue (MEDIAN)
Acute Myocardial Infarction (STEMI or NSTEMI) With Cardiogenic ShockDoor to Support Time < 90 Minutes78 Minutes
Other Pre-specified

Number of Participants With Establishment of TIMI III Coronary Blood Flow

Establishment of TIMI III (thrombolysis in myocardial infarction) coronary blood flow during index PCI (percutaneous coronary intervention) in culprit lesions.

Time frame: At index Cath Lab procedure/PCI (percutaneous coronary intervention).

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Acute Myocardial Infarction (STEMI or NSTEMI) With Cardiogenic ShockNumber of Participants With Establishment of TIMI III Coronary Blood Flow356 Participants
Other Pre-specified

Number of Vasopressors & Inotropes Used

Number of vasopressor & inotropic medications being administered in patients being treated with early MCS (mechanical circulatory support) during percutaneous coronary intervention (PCI) treatment for AMICS (acute myocardial infarction with cardiogenic shock).

Time frame: Prior to start of mechanical circulatory support during PCI (pre-PCI), post-PCI, 12-hours post-PCI, 24-hours post-PCI

ArmMeasureGroupValue (MEAN)Dispersion
Acute Myocardial Infarction (STEMI or NSTEMI) With Cardiogenic ShockNumber of Vasopressors & Inotropes Used# of Inotropes/Vasopressors being administered Pre-PCI1.0 # of Inotropes/Vasopressors administeredStandard Deviation 0.9
Acute Myocardial Infarction (STEMI or NSTEMI) With Cardiogenic ShockNumber of Vasopressors & Inotropes Used# of Inotropes/Vasopressors being administered Post-PCI0.9 # of Inotropes/Vasopressors administeredStandard Deviation 1
Acute Myocardial Infarction (STEMI or NSTEMI) With Cardiogenic ShockNumber of Vasopressors & Inotropes Used# of Inotropes/Vasopressors being administered at 12-hours Post-PCI1.1 # of Inotropes/Vasopressors administeredStandard Deviation 1.1
Acute Myocardial Infarction (STEMI or NSTEMI) With Cardiogenic ShockNumber of Vasopressors & Inotropes Used# of Inotropes/Vasopressors being administered at 24-hours Post-PCI1.0 # of Inotropes/Vasopressors administeredStandard Deviation 1
Other Pre-specified

Use of MCS Pre-PCI

Number of patients who receive mechanical circulatory support (MCS) pre-PCI (percutaneous coronary intervention).

Time frame: At index Cath Lab procedure/PCI (percutaneous coronary intervention)

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Acute Myocardial Infarction (STEMI or NSTEMI) With Cardiogenic ShockUse of MCS Pre-PCIMCS placed pre-PCI287 Participants
Acute Myocardial Infarction (STEMI or NSTEMI) With Cardiogenic ShockUse of MCS Pre-PCIMCS placed interprocedurally35 Participants
Acute Myocardial Infarction (STEMI or NSTEMI) With Cardiogenic ShockUse of MCS Pre-PCIMCS placed post-PCI84 Participants

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026