An observational study in Cardiogenic Shock, Acute Myocardial Infarction and STEMI - ST Elevation Myocardial Infarction, sponsored by Henry Ford Health System. Completed at 75 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-01.
Sponsored by Henry Ford Health System · Observational
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.
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.
277 studies on the registry are indexed under Shock, Cardiogenic; 127 are open to participants now.
This study's enrollment of 406 is above the median of 200 across 142 observational studies indexed under Shock, Cardiogenic.
Browse Shock, Cardiogenic studies →Henry Ford Health System is the lead sponsor of 293 studies on the registry; 50 are open to participants now.
Of its 35 completed or terminated interventional studies of FDA-regulated products, 23 (66%) have results posted.
Counted across the registry records on this site, refreshed daily.
Adult patients presenting with acute myocardial infarction and cardiogenic shock treated with mechanical circulatory support.
Registry Inclusion Criteria:
Cardiogenic shock is defined as the presence of at least two of the following:
Registry Exclusion Criteria:
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.
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.
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
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)
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)
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).
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
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
| Milestone | Acute Myocardial Infarction (STEMI or NSTEMI) With Cardiogenic Shock |
|---|---|
| Started | 406 |
| Completed | 406 |
| Not completed | 0 |
Number of Participants Who Survived at Discharge
| Participants | Acute Myocardial Infarction (STEMI or NSTEMI) With Cardiogenic Shock |
|---|---|
| Number of Participants Who Survived at Discharge | 287 |
Number of Participants Who Survived to 30 Days Post Hospital Discharge.
| Participants | Acute Myocardial Infarction (STEMI or NSTEMI) With Cardiogenic Shock |
|---|---|
| Number of Participants Who Survived to 30 Days Post Hospital Discharge. | 272 |
Number of Participants Who Survived to 1 Year Post Hospital Discharge.
| Participants | Acute Myocardial Infarction (STEMI or NSTEMI) With Cardiogenic Shock |
|---|---|
| Number of Participants Who Survived to 1 Year Post Hospital Discharge. | 173 |
Number of patients who receive mechanical circulatory support (MCS) pre-PCI (percutaneous coronary intervention).
| Participants | Acute Myocardial Infarction (STEMI or NSTEMI) With Cardiogenic Shock |
|---|---|
| MCS placed pre-PCI | 287 |
| MCS placed interprocedurally | 35 |
| MCS placed post-PCI | 84 |
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.
| Minutes | Acute Myocardial Infarction (STEMI or NSTEMI) With Cardiogenic Shock |
|---|---|
| Door to Support Time < 90 Minutes | 78 (41 to 237) |
Establishment of TIMI III (thrombolysis in myocardial infarction) coronary blood flow during index PCI (percutaneous coronary intervention) in culprit lesions.
| Participants | Acute Myocardial Infarction (STEMI or NSTEMI) With Cardiogenic Shock |
|---|---|
| Number of Participants With Establishment of TIMI III Coronary Blood Flow | 356 |
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).
| # of Inotropes/Vasopressors administered | Acute Myocardial Infarction (STEMI or NSTEMI) With Cardiogenic Shock |
|---|---|
| # of Inotropes/Vasopressors being administered Pre-PCI | 1.0 ± 0.9 |
| # of Inotropes/Vasopressors being administered Post-PCI | 0.9 ± 1.0 |
| # of Inotropes/Vasopressors being administered at 12-hours Post-PCI | 1.1 ± 1.1 |
| # of Inotropes/Vasopressors being administered at 24-hours Post-PCI | 1.0 ± 1.0 |
Ability to maintain a cardiac power output (CPO) measurement of \> 0.6 watts.
| Watts (W) | Acute Myocardial Infarction (STEMI or NSTEMI) With Cardiogenic Shock |
|---|---|
| CPO pre-PCI | 0.67 ± 0.29 |
| CPO post-PCI | 0.88 ± 0.44 |
| CPO 12-hours post-PCI | 0.83 ± 0.34 |
| CPO 24-hours post-PCI | 0.98 ± 1.32 |
Collected over Through study completion (hospital discharge), an average of 1 month and assessed up to 1 year post hospital discharge, up to 13 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Acute Myocardial Infarction (STEMI or NSTEMI) With Cardiogenic Shock | 152/406 (37.4%) | 83/365 (22.7%) | — |
| Event | Acute Myocardial Infarction (STEMI or NSTEMI) With Cardiogenic Shock |
|---|---|
| Blood transfusionBlood and lymphatic system disorders | 83/365 |
| Limb IschemiaVascular disorders | 11/365 |
| StrokeVascular disorders | 7/365 |
| Age, Continuous(Years) | Acute Myocardial Infarction (STEMI or NSTEMI) With Cardiogenic Shock |
|---|---|
| Mean | 63.7 ± 12.3 |
| Sex: Female, Male(Participants) | Acute Myocardial Infarction (STEMI or NSTEMI) With Cardiogenic Shock |
|---|---|
| Female | 96 |
| Male | 310 |
| Race/Ethnicity, Customized(Participants) | Acute Myocardial Infarction (STEMI or NSTEMI) With Cardiogenic Shock |
|---|---|
| White | 277 |
| Black | 34 |
| Hispanic | 28 |
| Other | 30 |
| Patient refused to reveal or information not available | 37 |
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