NCT07817472Not yet recruiting
Optimal Timing of Microaxial Flow Pump(Impella CP) in AMI-related Cardiogenic Shock
Routine PRe-PCI Versus Selective Post-PCI Impella CP Management and Evaluation in Acute Myocardial Infarction-Related Cardiogenic SHOCK
Source: ClinicalTrials.gov · Last updated 14 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 126 (estimated)
- First submitted
- 6 Sept 2026
- Start date
- 1 Oct 2026
- Primary completion date
- 31 Aug 2029
- Lead sponsor
- Chonnam National University Hospital
- Diseases
- Coronary artery disease
- NCT number
- NCT07817472
What you commit to
- Study type: Interventional
- Planned participants: 126
- From 1 Oct 2026 to the primary completion date, 31 Aug 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior mechanical circulatory support before randomization
Other illness
- Non-acute myocardial infarction-related shock
- Mechanical complication of myocardial infarction
- Refractory ventricular arrhythmia
- Unwitnessed cardiac arrest without bystander cardiopulmonary resuscitation
- Active major bleeding or inability to receive anticoagulation or antiplatelet therapy required for percutaneous coronary intervention and Impella CP support
Other
- No clear culprit lesion
- Predominant right ventricular or biventricular shock
- Ongoing cardiopulmonary resuscitation at the time of screening
- Cardiopulmonary resuscitation duration \>45 minutes
- Glasgow Coma Scale \<8 after return of spontaneous circulation
- Contraindication to Impella CP use
- Life expectancy \<1 year
Who the study is looking for
- Age ≥19 years old
- Acute myocardial infarction with culprit lesion requiring urgent percutaneous coronary intervention
- Cardiogenic shock before culprit lesion percutaneous coronary intervention
- Left ventricular ejection fraction ≤40%
- Patients with persistent signs of shock despite medical therapy who are scheduled to undergo Impella CP insertion
- Shock onset to randomization ≤12 hours
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chonnam National University Hospital Coordinator of this site? Confirm its status | Gwangju | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.