Acute Myocardial Infarction, Cardiogenic Shock, Heart Attack, NSTEMI - Non-ST Segment Elevation MI, STEMI - ST Elevation Myocardial Infarction
Conditions
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
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Survived at Discharge | through study completion (hospital discharge), an average of 30 days. | Number of Participants Who Survived at Discharge |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 year | Number of Participants Who Survived to 1 Year Post Hospital Discharge. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Vasopressors & Inotropes Used | Prior to start of mechanical circulatory support during PCI (pre-PCI), post-PCI, 12-hours post-PCI, 24-hours post-PCI | 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). |
| Use of MCS Pre-PCI | At 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-PCI | 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. |
| Door to Support Time < 90 Minutes | At 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 Flow | At 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
| Arm | Count |
|---|---|
| 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 |
| Total | 406 |
Baseline characteristics
| Characteristic | Acute Myocardial Infarction (STEMI or NSTEMI) With Cardiogenic Shock |
|---|---|
| Age, Continuous | 63.7 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 type | EG000 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
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Acute Myocardial Infarction (STEMI or NSTEMI) With Cardiogenic Shock | Number of Participants Who Survived at Discharge | 287 Participants |
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Acute Myocardial Infarction (STEMI or NSTEMI) With Cardiogenic Shock | Number of Participants Who Survived to 1 Year Post Hospital Discharge. | 173 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Acute Myocardial Infarction (STEMI or NSTEMI) With Cardiogenic Shock | Number of Participants Who Survived to 30 Days Post Hospital Discharge. | 272 Participants |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Acute Myocardial Infarction (STEMI or NSTEMI) With Cardiogenic Shock | Average Cardiac Power Output (CPO) Measurements at Index PCI (Percutaneous Coronary Intervention), Post-PCI, 12 Hours Post-PCI, 24 Hours Post-PCI | CPO pre-PCI | 0.67 Watts (W) | Standard Deviation 0.29 |
| Acute Myocardial Infarction (STEMI or NSTEMI) With Cardiogenic Shock | Average Cardiac Power Output (CPO) Measurements at Index PCI (Percutaneous Coronary Intervention), Post-PCI, 12 Hours Post-PCI, 24 Hours Post-PCI | CPO post-PCI | 0.88 Watts (W) | Standard Deviation 0.44 |
| Acute Myocardial Infarction (STEMI or NSTEMI) With Cardiogenic Shock | Average Cardiac Power Output (CPO) Measurements at Index PCI (Percutaneous Coronary Intervention), Post-PCI, 12 Hours Post-PCI, 24 Hours Post-PCI | CPO 12-hours post-PCI | 0.83 Watts (W) | Standard Deviation 0.34 |
| Acute Myocardial Infarction (STEMI or NSTEMI) With Cardiogenic Shock | Average Cardiac Power Output (CPO) Measurements at Index PCI (Percutaneous Coronary Intervention), Post-PCI, 12 Hours Post-PCI, 24 Hours Post-PCI | CPO 24-hours post-PCI | 0.98 Watts (W) | Standard Deviation 1.32 |
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)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Acute Myocardial Infarction (STEMI or NSTEMI) With Cardiogenic Shock | Door to Support Time < 90 Minutes | 78 Minutes |
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).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Acute Myocardial Infarction (STEMI or NSTEMI) With Cardiogenic Shock | Number of Participants With Establishment of TIMI III Coronary Blood Flow | 356 Participants |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Acute Myocardial Infarction (STEMI or NSTEMI) With Cardiogenic Shock | Number of Vasopressors & Inotropes Used | # of Inotropes/Vasopressors being administered Pre-PCI | 1.0 # of Inotropes/Vasopressors administered | Standard Deviation 0.9 |
| Acute Myocardial Infarction (STEMI or NSTEMI) With Cardiogenic Shock | Number of Vasopressors & Inotropes Used | # of Inotropes/Vasopressors being administered Post-PCI | 0.9 # of Inotropes/Vasopressors administered | Standard Deviation 1 |
| Acute Myocardial Infarction (STEMI or NSTEMI) With Cardiogenic Shock | Number of Vasopressors & Inotropes Used | # of Inotropes/Vasopressors being administered at 12-hours Post-PCI | 1.1 # of Inotropes/Vasopressors administered | Standard Deviation 1.1 |
| Acute Myocardial Infarction (STEMI or NSTEMI) With Cardiogenic Shock | Number of Vasopressors & Inotropes Used | # of Inotropes/Vasopressors being administered at 24-hours Post-PCI | 1.0 # of Inotropes/Vasopressors administered | Standard Deviation 1 |
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)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Acute Myocardial Infarction (STEMI or NSTEMI) With Cardiogenic Shock | Use of MCS Pre-PCI | MCS placed pre-PCI | 287 Participants |
| Acute Myocardial Infarction (STEMI or NSTEMI) With Cardiogenic Shock | Use of MCS Pre-PCI | MCS placed interprocedurally | 35 Participants |
| Acute Myocardial Infarction (STEMI or NSTEMI) With Cardiogenic Shock | Use of MCS Pre-PCI | MCS placed post-PCI | 84 Participants |