Trial Outcomes & Findings for National Cardiogenic Shock Initiative (NCT NCT03677180)

NCT ID: NCT03677180

Last Updated: 2025-07-01

Results Overview

Number of Participants Who Survived at Discharge

• Recruitment status: COMPLETED
• Target enrollment: 406 participants
• Primary outcome timeframe: through study completion (hospital discharge), an average of 30 days.
• Results posted on: 2025-07-01

Participant Flow

Participant milestones

Measure	Acute Myocardial Infarction (STEMI or NSTEMI) With Cardiogenic Shock Patients who presented with an acute MI (STEMI or NSTEMI) and in cardiogenic shock prior to percutaneous coronary intervention (PCI).
Overall Study STARTED	406
Overall Study COMPLETED	406
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

National Cardiogenic Shock Initiative

Baseline characteristics by cohort

Measure	Acute Myocardial Infarction (STEMI or NSTEMI) With Cardiogenic Shock n=406 Participants 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).
Age, Continuous	63.7 Years STANDARD_DEVIATION 12.3 • n=5 Participants
Sex: Female, Male Female	96 Participants n=5 Participants
Sex: Female, Male Male	310 Participants n=5 Participants
Race/Ethnicity, Customized White	277 Participants n=5 Participants
Race/Ethnicity, Customized Black	34 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	28 Participants n=5 Participants
Race/Ethnicity, Customized Other	30 Participants n=5 Participants
Race/Ethnicity, Customized Patient refused to reveal or information not available	37 Participants n=5 Participants

PRIMARY outcome

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

Number of Participants Who Survived at Discharge

Outcome measures

Measure	Acute Myocardial Infarction (STEMI or NSTEMI) With Cardiogenic Shock n=406 Participants Patients who presented to the hospital with an acute MI (STEMI or NSTEMI) and in cardiogenic shock prior to percutaneous coronary intervention (PCI).
Number of Participants Who Survived at Discharge	287 Participants

SECONDARY outcome

Timeframe: 30 days post-hospital discharge.

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

Outcome measures

Measure	Acute Myocardial Infarction (STEMI or NSTEMI) With Cardiogenic Shock n=399 Participants Patients who presented to the hospital with an acute MI (STEMI or NSTEMI) and in cardiogenic shock prior to percutaneous coronary intervention (PCI).
Number of Participants Who Survived to 30 Days Post Hospital Discharge.	272 Participants

SECONDARY outcome

Timeframe: 1 year

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

Outcome measures

Measure	Acute Myocardial Infarction (STEMI or NSTEMI) With Cardiogenic Shock n=325 Participants Patients who presented to the hospital with an acute MI (STEMI or NSTEMI) and in cardiogenic shock prior to percutaneous coronary intervention (PCI).
Number of Participants Who Survived to 1 Year Post Hospital Discharge.	173 Participants

OTHER_PRE_SPECIFIED outcome

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

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

Outcome measures

Measure	Acute Myocardial Infarction (STEMI or NSTEMI) With Cardiogenic Shock n=406 Participants Patients who presented to the hospital with an acute MI (STEMI or NSTEMI) and in cardiogenic shock prior to percutaneous coronary intervention (PCI).
Use of MCS Pre-PCI MCS placed pre-PCI	287 Participants
Use of MCS Pre-PCI MCS placed interprocedurally	35 Participants
Use of MCS Pre-PCI MCS placed post-PCI	84 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Measure	Acute Myocardial Infarction (STEMI or NSTEMI) With Cardiogenic Shock n=406 Participants Patients who presented to the hospital with an acute MI (STEMI or NSTEMI) and in cardiogenic shock prior to percutaneous coronary intervention (PCI).
Door to Support Time < 90 Minutes	78 Minutes Interval 41.0 to 237.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Measure	Acute Myocardial Infarction (STEMI or NSTEMI) With Cardiogenic Shock n=406 Participants Patients who presented to the hospital with an acute MI (STEMI or NSTEMI) and in cardiogenic shock prior to percutaneous coronary intervention (PCI).
Number of Participants With Establishment of TIMI III Coronary Blood Flow	356 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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).

Outcome measures

Measure	Acute Myocardial Infarction (STEMI or NSTEMI) With Cardiogenic Shock n=406 Participants Patients who presented to the hospital with an acute MI (STEMI or NSTEMI) and in cardiogenic shock prior to percutaneous coronary intervention (PCI).
Number of Vasopressors & Inotropes Used # of Inotropes/Vasopressors being administered Pre-PCI	1.0 # of Inotropes/Vasopressors administered Standard Deviation 0.9
Number of Vasopressors & Inotropes Used # of Inotropes/Vasopressors being administered Post-PCI	0.9 # of Inotropes/Vasopressors administered Standard Deviation 1.0
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
Number of Vasopressors & Inotropes Used # of Inotropes/Vasopressors being administered at 24-hours Post-PCI	1.0 # of Inotropes/Vasopressors administered Standard Deviation 1.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Measure	Acute Myocardial Infarction (STEMI or NSTEMI) With Cardiogenic Shock n=406 Participants Patients who presented to the hospital with an acute MI (STEMI or NSTEMI) and in cardiogenic shock prior to percutaneous coronary intervention (PCI).
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
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
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
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

Adverse Events

Acute Myocardial Infarction (STEMI or NSTEMI) With Cardiogenic Shock

Serious events: 83 serious events

Other events: 0 other events

Deaths: 152 deaths

Serious adverse events

Measure	Acute Myocardial Infarction (STEMI or NSTEMI) With Cardiogenic Shock n=365 participants at risk Patients who presented with an acute MI (STEMI or NSTEMI) and in cardiogenic shock prior to percutaneous coronary intervention (PCI).
Blood and lymphatic system disorders Blood transfusion	22.7% 83/365 • Number of events 83 • Through study completion (hospital discharge), an average of 1 month and assessed up to 1 year post hospital discharge, up to 13 months. All 406 participants were monitored up to hospital discharge, however only 325 participants assessed for All-Cause Mortality at 1 year. Data were only available for 365 of the subjects for Adverse Events. Adverse Event Data for the remaining 41 subjects were not able to be collected by the site for adverse events. Other \[non-serious\] adverse events were not collected or assessed as part of the study.
Vascular disorders Stroke	1.9% 7/365 • Number of events 7 • Through study completion (hospital discharge), an average of 1 month and assessed up to 1 year post hospital discharge, up to 13 months. All 406 participants were monitored up to hospital discharge, however only 325 participants assessed for All-Cause Mortality at 1 year. Data were only available for 365 of the subjects for Adverse Events. Adverse Event Data for the remaining 41 subjects were not able to be collected by the site for adverse events. Other \[non-serious\] adverse events were not collected or assessed as part of the study.
Vascular disorders Limb Ischemia	3.0% 11/365 • Number of events 11 • Through study completion (hospital discharge), an average of 1 month and assessed up to 1 year post hospital discharge, up to 13 months. All 406 participants were monitored up to hospital discharge, however only 325 participants assessed for All-Cause Mortality at 1 year. Data were only available for 365 of the subjects for Adverse Events. Adverse Event Data for the remaining 41 subjects were not able to be collected by the site for adverse events. Other \[non-serious\] adverse events were not collected or assessed as part of the study.

Other adverse events

Adverse event data not reported

Additional Information

Dr. Mir Babar Basir

Henry Ford Hospital

Phone: 313-916-2896

Email: mbasir1@hfhs.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place