An interventional study of Routine pre-PCI Impella CP and Selective post-PCI Impella CP in Myocardial Infarction (MI), Cardiogenic Shock and ST-Segment Elevation Myocardial Infarction(STEMI), sponsored by Chonnam National University Hospital. Not yet recruiting at 1 site in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-09-14.
Sponsored by Chonnam National University Hospital · Not applicable, Interventional, and Treatment
PRIME-SHOCK is a prospective, single-center, open-label, randomized, superiority trial. Eligible participants with AMICS and a clinical decision to use Impella CP will be randomized in a 1:1 ratio before culprit-lesion PCI. The routine pre-PCI group will undergo Impella CP insertion immediately after allocation and before culprit-lesion PCI. The selective post-PCI group will undergo culprit-lesion PCI first; Impella CP will be inserted only if prespecified intra-procedural rescue criteria are met or shock persists or worsens after successful PCI. If all post-PCI recovery criteria are met, PCI will be concluded without Impella CP.
Vasopressors and inotropes are often required to maintain blood pressure and organ perfusion, but high doses or prolonged use can increase myocardial oxygen demand, provoke arrhythmia, and worsen peripheral vasoconstriction. Routine mechanical circulatory support for unselected AMICS populations has not consistently improved outcomes.
Impella CP is a percutaneous transvalvular microaxial flow pump inserted through the femoral artery. It transfers blood from the left ventricle to the ascending aorta, supporting systemic circulation while unloading the left ventricle and potentially reducing filling pressure, wall stress, and myocardial oxygen demand. The randomized DanGer-Shock (Danish Cardiogenic Shock) trial established a potential survival benefit in selected AMICS patients while reinforcing the need to optimize use and limit device-related harm.
The 2025 American guideline for the management of acute coronary syndromes states that, in selected patients with ST-segment elevation myocardial infarction (STEMI) and severe or refractory cardiogenic shock, the use of a microaxial flow pump may be reasonable to reduce the risk of death. However, in the DanGer-Shock trial, randomization concerned the use of the Impella CP, whereas the timing of device insertion, before or after PCI, was neither randomized nor specified by the study protocol. Accordingly, the guideline also acknowledges that the preferred timing of Impella insertion remains unclear. Therefore, the results of DanGer-Shock alone do not establish the superiority of pre-PCI over post-PCI insertion, and a randomized trial directly comparing these two strategies is warranted.
This study will randomly compare the clinical efficacy and safety of a routine pre-PCI Impella CP insertion strategy with a PCI-first strategy involving selective Impella CP insertion. It will determine whether the potential benefits of early left ventricular unloading and hemodynamic stabiliation outweigh the risks associated with pre-emptive device insertion in all patients, or whether restricting Impella CP use to patients with persistent shock after initial coronary revascularization can reduce unnecessary device use and related complications while providing comparable or superior clinical outcomes. This study has important clinical significance because it will address a key unresolved question following the DanGer-Shock trial, moving beyond "whether to use the Impella CP" to "in whom and when it should be used". By incorporating the potential benefit of avoiding device use in patients whose shock resolves with PCI alone, while simultaneously evaluating the risks of delaying circulatory support in those who require early mechanical support, this study is expected to provide a more individualized, evidence-based strategy for Impella CP use in patients with AMICS.
- Study Hypothesis: Routine pre-PCI Impella CP will reduce the composite of all-cause death within 30 days after randomization or refractory shock within 48 hours after index PCI compared with revascularization first and selective post-PCI Impella CP.
2,270 studies on the registry are indexed under Myocardial Infarction; 371 are open to participants now.
This study's planned enrollment of 126 is below the median of 150 across 1,314 interventional studies indexed under Myocardial Infarction.
Browse Myocardial Infarction studies →Chonnam National University Hospital is the lead sponsor of 72 studies on the registry; 15 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
In the pre-percutaneous coronary intervention (PCI) Impella CP group, Impella CP will be routinely inserted before culprit lesion PCI in patients with acute myocardial infarction-related cardiogenic shock.
Procedure: Routine pre-PCI Impella CP
The selective post-percutaneous coronary intervention (PCI) Impella CP group will undergo culprit-lesion PCI first; Impella CP will be inserted only if prespecified intra-procedural rescue criteria are met or shock persists or worsens after successful PCI for culprit lesion.
Procedure: Selective post-PCI Impella CP
In the PCI Impella CP group, Impella CP will be routinely inserted before culprit lesion PCI in patients with acute myocardial infarction-related cardiogenic shock.
The selective post-PCI Impella CP group will undergo culprit-lesion PCI first; Impella CP will be inserted only if prespecified intra-procedural rescue criteria are met or shock persists or worsens after successful PCI for culprit lesion. In the selective post-PCI group, immediate mechanical circulatory support will be instituted during PCI if any of the criteria are met. Impella CP is preferred when feasible. VA-ECMO may be initiated during resuscitation when Impella CP cannot be placed promptly or is insufficient. In the selective post-PCI group, successful culprit-lesion revascularization is done without shock progession, PCI will be concluded without Impella CP only when all of the criteria are met.
Composite of all-cause death or refractory shock within 48 hours after index percutaneous coronary intervention
Time frame: At 30 days after randomization
Composite of all-cause death or refractory shock within 48 hours after index percutaneous coronary intervention
Time frame: At 12 months after randomization
All-cause death
Time frame: At 30 days and 12 months after randomization
Number of participants with refractory shock within 48 hours after index percutaneous coronary intervention (PCI), assessed using prespecified clinical, hemodynamic, and arterial lactate criteria
Refractory shock is defined as any of: (1) rescue escalation to mechanical circulatory support beyond the randomized strategy, (2) acute cardiac arrest, or (3) persistent or worsening tissue hypoperfusion requiring at least one arterial lactate criterion AND at least one concurrent hemodynamic/organ-perfusion criterion. Lactate criteria: two consecutive increases at approximately 2-hour intervals, 24-hour lactate clearance \<40 percent with lactate ≥4 mmol/L at 24 hours, or persistent lactate ≥5 mmol/L during hours 24-48. Concurrent criteria: increasing vasopressor requirement, use of ≥2 vasoactive agents; persistent mean arterial pressure \<65 mm Hg, urine output \<0.5 mL/kg/h for ≥6 hours; cardiac power output \<0.6 W, or cardiac index \<2.2 L/min/m\^2. Protocol-concordant post-PCI Impella CP insertion in the selective group is not, by itself, rescue escalation.
Time frame: Within 48 hours after index percutaneous coronary intervention
Time from randomization to arterial lactate <2.0 mmol/L
Time frame: At 30 days after randomization
24-hour arterial lactate clearance
Time frame: At 24 hours after randomization
Cardiac death
Time frame: At 30 days and 12 months after randomization
Rate of ischemic or hemorrhagic stroke
Time frame: At 30 days and 12 months after randomization
Rate of renal replacement therapy
Time frame: At 30 days and 12 months after randomization
Rate of limb ischemia
Time frame: At 30 days and 12 months after randomization
Rate of clinically significant Impella CP-related hemolysis
Time frame: At hospital discharge (up to 30 days)
Major bleeding (Bleeding Academic Research Consortium [BARC] type 3 or 5 bleeding)
Time frame: At 30 days and 12 months after randomization
Major vascular complications
Time frame: At 30 days and 12 months after randomization
Sepsis or bloodstream infection
Time frame: At 30 days and 12 months after randomization
Impella CP malfunction, malposition, or device-related cardiac or vascular injury
Time frame: At hospital discharge (up to 30 days)
Rate of hospitalization for heart failure
Time frame: At 12 months after randomization
Rate of stent thrombosis
Time frame: At 30 days and 12 months after randomization
Plan to share: No
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Start is estimated for Oct 2026; primary completion for Aug 2029, 34 months later.
Of 321 non-industry interventional studies with no phase under Myocardial Infarction, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 58. This study's planned 34 months is close to that.
Counting every sponsor, half of 354 studies reached it within 34 months; a quarter within 15 and three quarters within 57.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Chonnam National University Hospital