Cardiogenic ShockPhase 4RESCUE-SHOCKNCT05527717
Revascularization Strategy of Multivessel Disease for Patients with Acute Myocardial Infarction Complicated by Cardiogenic Shock Undergoing Veno-arterial Extracorporeal Membrane Oxygenator
A Phase 4 study testing Culprit lesion only PCI and Immediate multi-vessel PCI in people with Cardiogenic Shock and Acute Myocardial Infarction, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
This study is a prospective, open-label, two-arm, randomized multicenter trial to identify whether immediate multi-vessel PCI would be better in clinical outcomes compared with culprit lesion-only PCI for AMI and multi-vessel disease with an advanced form of CS patients who require veno-arterial extracorporeal… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Cardiogenic Shock, Acute Myocardial Infarction, Multi Vessel Coronary Artery Disease
- What is being tested?
- Culprit lesion only PCI and Immediate multi-vessel PCI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 560 participants
- Where
- 1 siteSouth Korea
- Study dates
- 16 Nov 2022to 31 Dec 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject must be at least 19 years of age
- Patients presented with AMI (ST-segment elevation MI [STEMI] or non-ST-segment elevation MI [NSTEMI]) complicated by CS (SCAI Shock classification C, D or E) who requiring VA-ECMO.
- Target lesions amenable for planned primary PCI by operators' decision
- Patients with multi-vessel disease
Who cannot join
- Other causes of shock (hypovolemia, sepsis, obstructive shock).
- Shock due to mechanical complication to MI (rupture of papillary muscle, the ventricular septum, or free wall).
- Unwitnessed out of hospital cardiac arrest with persistent Glasgow coma scale <8 after the return of spontaneous circulation.
- Patients with single-vessel disease (Patients with single-vessel disease will be enrolled in the RESCUE-SHOCK registry)
- Onset of shock >24 hours.
- Known heparin intolerance.
Show all 9Show fewer
- Other severe concomitant disease with limited life expectancy < 6 months
- Pregnancy or breast feeding
- Do not resuscitate wish
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, 06351
Jeong Hoon Yang, MD, 82-2-3410-3419, jhysmc@gmail.com
About this study
Official title: REvaSCUlarization StratEgy of Multivessel Coronary Artery Disease for Patients with Acute Myocardial Infarction Complicated by Cardiogenic SHOCK Undergoing Veno-arterial Extracorporeal Membrane Oxygenator: Randomized-Controlled Trial (RESCUE-SHOCK)
This study is a prospective, open-label, two-arm, randomized multicenter trial to identify whether immediate multi-vessel PCI would be better in clinical outcomes compared with culprit lesion-only PCI for AMI and multi-vessel disease with an advanced form of CS patients who require veno-arterial extracorporeal membrane oxygenator (VA-ECMO).
Read the detailed description
Cardiogenic shock (CS) is a fatal complication of acute myocardial infarction (AMI). Until now, in this setting, it has been well-known that early revascularization with percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) was associated with improved clinical outcomes although the rate of mortality remains still high in the mechanical circulatory support (MCS) era. In real-world practice, since clinically significant non-infarct related artery (non-IRA) stenosis or occlusion in addition to an IRA can be found in 70% to 80% of patients with AMI complicated by CS, the decision of revascularization strategy is a crucial issue to improve clinical outcomes in CS patients with multivessel disease. The 2013 American College of Cardiology (ACC)/American Heart Association (AHA) and the 2017 European Society of Cardiology (ESC) guidelines recommend considering PCI of severe stenosis in non-IRA during a primary procedure to improve overall myocardial perfusion and hemodynamic stability for patients with AMI and CS. However, the CULPRIT-SHOCK trial, which is the largest randomized trial in CS, demonstrated the 30-day risk of a composite of death or severe renal failure leading to renal-replacement therapy was higher in the immediate multi-vessel PCI than in the culprit lesion-only PCI group. In this regard, the recently updated guidelines do not recommend the routine non-IRA revascularization during primary PCI and it should be considered in selected cases in which there is a very severe flow-limiting non-IRA stenosis irrigating a large myocardial area. Nevertheless, there is still some unsolved issue regarding the role of non-IRA revascularization in AMI patients with CS. Majority of enrolled patients in the CULPRIT-SHOCK trial might have a mild form of CS (median systolic blood pressure of 100) and few patients received MCS devices (28.3% of study population). Furthermore, the mortality benefits of culprit-only PCI were attenuated at 1-year follow-up with an increased risk of repeat revascularization and hospitalization for heart failure. In contrast to the CULPRIT-SHOCK trial, the recent large United State registry from National Cardiovascular Data Registry demonstrated that the benefits of multi-vessel PCI in patients with non-ST-segment elevation MI and CS was more pronounced in those requiring MCS. In addition, recent data from the Korea Acute Myocardial Infarction National Health Registry showed that multivessel PCI was associated with a lower risk of all-cause death than culprit-only PCI, suggesting possible benefit of nonculprit lesion revascularization during the index hospitalization on long-term clinical outcomes.
Therefore, the current randomized trial sought to identify whether immediate multi-vessel PCI would be better in clinical outcomes compared with culprit lesion-only PCI for AMI and multi-vessel disease with advanced form of CS patients who requiring veno-arterial extracorporeal membrane oxygenator (VA-ECMO).
- Conditions
- Cardiogenic Shock, Acute Myocardial Infarction, Multi Vessel Coronary Artery Disease, Extracorporeal Membrane Oxygenation
- Being tested
- Culprit lesion only PCI, Immediate multi-vessel PCI
- Medical subject headings
- Shock, Cardiogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Culprit lesion only PCIProcedure or surgery
Randomization will be done after coronary angiography before or during primary PCI for IRA. Patients will be randomized to either immediate multi-vesesl PCI group or culprit-lesion only PCI group with 1:1 ratio.
This group will be taken culprit-lesion only PCI during primary PCI.
Immediate multi-vessel PCIProcedure or surgery
Randomization will be done after coronary angiography before or during primary PCI for IRA. Patients will be randomized to either immediate multi-vesesl PCI group or culprit-lesion only PCI group with 1:1 ratio.
This group will be taken immediate multi-vesesl PCI during primary PCI.
| Study group | Role | What they receive |
|---|---|---|
| Culprit-lesion only PCI arm | Active comparator | Patients will receive culprit-lesion only PCI. Receives: Procedure: Culprit lesion only PCI |
| Immediate multi-vesesl PCI arm | Experimental | Patients will receive immediate multi-vessel PCI. Receives: Procedure: Immediate multi-vessel PCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of all-cause mortality or advanced heart failure requiring cardiac replacement therapy
all-cause mortality or requiring left ventricular assisted device (LVAD) insertion or heart transplantation)
Measured: 90 days after primary PCI
Secondary outcomes (25)
Rates of In-hospital mortality
Death by any cause in hospital
Measured: Up to 30 days
Rates of In-hospital cardiac mortality
Death by cardiac cause in hospital
Measured: Up to 30 days
Rates of VA-ECMO weaning success
Successful weaning of VA-ECMO was defined as successful removal of VA-ECMO and not requiring further mechanical support because of recurring cardiogenic shock over the following 48 hours.
Measured: Up to 30 days
Time to VA-ECMO weaning
Time from VA-ECMO insertion to VA-ECMO weaning
Measured: Up to 30 days
Rates of critical limb ischemia after successful VA-ECMO weaning
Critical limb ischemia is defined as limb pain that occurs at rest, or impending limb loss that is caused by severe compromise of blood flow to the affected extremity. (Rutherford classification 4, 5, or 6)
Measured: Up to 30 days
Cerebral Performance Category (CPC) 3-5 at discharge
Neurologic performance scale at discharge
Measured: Up to 30 days
Length of intensive-care unit (ICU) stay
ICU stay day
Measured: Up to 30 days
Total procedural time
Procedural time (minutes)
Measured: Immediate after the index procedure
Total amount of contrast use
Contrast use (cc)
Measured: Immediate after the index procedure
Rates of all-cause mortality
Death by any cause
Measured: 90 Days and 12 months after primary PCI
Rates of cardiac mortality
Death by cardiac cause
Measured: 90 Days and 12 months after primary PCI
Requirement of cardiac replacement therapy
LVAD insertion or heart transplantation
Measured: 90 Days and 12 months after primary PCI
Requirement of renal replacement therapy
Continuous renal replacement therapy, hemodialysis, or peritoneal dialysis
Measured: 90 Days and 12 months after primary PCI
Rates of myocardial infarction (MI)
spontaneous MI during follow-up
Measured: 90 Days and 12 months after primary PCI
Rates of MI related to culprit vessel
MI related to culprit vessel during follow-up
Measured: 90 Days and 12 months after primary PCI
Rates of MI related to non-culprit vessel
MI related to non-culprit vessel during follow-up
Measured: 90 Days and 12 months after primary PCI
Rates of stent thrombosis
Academic Research Consortium (ARC)-defined definite or probable stent thrombosis
Measured: 90 Days and 12 months after primary PCI
Rates of Re-hospitalization due to heart failure
Re-hospitalization due to heart failure during follow-up
Measured: 90 Days and 12 months after primary PCI
Rates of Re-hospitalization due to any cause
Re-hospitalization due to any cause during follow-up
Measured: 90 Days and 12 months after primary PCI
Rates of target-lesion revascularization (TLR)
TLR during follow-up
Measured: 90 Days and 12 months after primary PCI
Rates of target-vessel revascularization (TVR)
TVR during follow-up
Measured: 90 Days and 12 months after primary PCI
Rates of repeat revascularization
Repeat revascularization during follow-up
Measured: 90 Days and 12 months after primary PCI
Rates of cerebrovascular accident
Cerebrovascular accident during follow-up
Measured: 90 Days and 12 months after primary PCI
Rates of bleeding
Bleeding ARC [BARC] type 2, 3, or 5
Measured: 90 Days and 12 months after primary PCI
Rates of major bleeding
(BARC type 3 or 5
Measured: 90 Days and 12 months after primary PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2022
- Study start16 Nov 2022
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiogenic ShockStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, open-label, two-arm, randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 560 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeong Hoon Yang, Samsung Medical Center
- Investigators
- Jeong Hoon Yang, MD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05527717
- Sponsor's protocol ID
- RESCUE-SHOCK
- Acronym
- RESCUE-SHOCK
- Status last verified
- Nov 2024
- First submitted
- 27 Aug 2022
- Last updated
- 6 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REvaSCUlarization StratEgy of Multivessel Coronary Artery Disease for Patients with Acute Myocardial Infarction Complicated by Cardiogenic SHOCK Undergoing Veno-arterial Extracorporeal Membrane Oxygenator: Randomized-Controlled Trial (RESCUE-SHOCK)
- ClinicalTrials.gov ID
- NCT05527717
- Acronym / sponsor ID
- RESCUE-SHOCK / RESCUE-SHOCK
- Conditions
- Cardiogenic Shock, Acute Myocardial Infarction, Multi Vessel Coronary Artery Disease, Extracorporeal Membrane Oxygenation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 560 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 16 Nov 2022 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 2 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a prospective, open-label, two-arm, randomized multicenter trial to identify whether immediate multi-vessel PCI would be better in clinical outcomes compared with culprit lesion-only PCI for AMI and multi-vessel disease with an advanced form of CS patients who require veno-arterial extracorporeal membrane oxygenator (VA-ECMO).
Detailed description
Cardiogenic shock (CS) is a fatal complication of acute myocardial infarction (AMI). Until now, in this setting, it has been well-known that early revascularization with percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) was associated with improved clinical outcomes although the rate of mortality remains still high in the mechanical circulatory support (MCS) era. In real-world practice, since clinically significant non-infarct related artery (non-IRA) stenosis or occlusion in addition to an IRA can be found in 70% to 80% of patients with AMI complicated by CS, the decision of revascularization strategy is a crucial issue to improve clinical outcomes in CS patients with multivessel disease. The 2013 American College of Cardiology (ACC)/American Heart Association (AHA) and the 2017 European Society of Cardiology (ESC) guidelines recommend considering PCI of severe stenosis in non-IRA during a primary procedure to improve overall myocardial perfusion and hemodynamic stability for patients with AMI and CS. However, the CULPRIT-SHOCK trial, which is the largest randomized trial in CS, demonstrated the 30-day risk of a composite of death or severe renal failure leading to renal-replacement therapy was higher in the immediate multi-vessel PCI than in the culprit lesion-only PCI group. In this regard, the recently updated guidelines do not recommend the routine non-IRA revascularization during primary PCI and it should be considered in selected cases in which there is a very severe flow-limiting non-IRA stenosis irrigating a large myocardial area. Nevertheless, there is still some unsolved issue regarding the role of non-IRA revascularization in AMI patients with CS. Majority of enrolled patients in the CULPRIT-SHOCK trial might have a mild form of CS (median systolic blood pressure of 100) and few patients received MCS devices (28.3% of study population). Furthermore, the mortality benefits of culprit-only PCI were attenuated at 1-year follow-up with an increased risk of repeat revascularization and hospitalization for heart failure. In contrast to the CULPRIT-SHOCK trial, the recent large United State registry from National Cardiovascular Data Registry demonstrated that the benefits of multi-vessel PCI in patients with non-ST-segment elevation MI and CS was more pronounced in those requiring MCS. In addition, recent data from the Korea Acute Myocardial Infarction National Health Registry showed that multivessel PCI was associated with a lower risk of all-cause death than culprit-only PCI, suggesting possible benefit of nonculprit lesion revascularization during the index hospitalization on long-term clinical outcomes.
Therefore, the current randomized trial sought to identify whether immediate multi-vessel PCI would be better in clinical outcomes compared with culprit lesion-only PCI for AMI and multi-vessel disease with advanced form of CS patients who requiring veno-arterial extracorporeal membrane oxygenator (VA-ECMO).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, open-label, two-arm, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Culprit-lesion only PCI arm | Active comparator | Procedure: Culprit lesion only PCIPatients will receive culprit-lesion only PCI. |
| Immediate multi-vesesl PCI arm | Experimental | Procedure: Immediate multi-vessel PCIPatients will receive immediate multi-vessel PCI. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject must be at least 19 years of age
- Patients presented with AMI (ST-segment elevation MI [STEMI] or non-ST-segment elevation MI [NSTEMI]) complicated by CS (SCAI Shock classification C, D or E) who requiring VA-ECMO.
- Target lesions amenable for planned primary PCI by operators' decision
- Patients with multi-vessel disease
Key exclusion criteria (9 listed)
- Other causes of shock (hypovolemia, sepsis, obstructive shock).
- Shock due to mechanical complication to MI (rupture of papillary muscle, the ventricular septum, or free wall).
- Unwitnessed out of hospital cardiac arrest with persistent Glasgow coma scale <8 after the return of spontaneous circulation.
- Patients with single-vessel disease (Patients with single-vessel disease will be enrolled in the RESCUE-SHOCK registry)
- Onset of shock >24 hours.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Culprit lesion only PCIRandomization will be done after coronary angiography before or during primary PCI for IRA. Patients will be randomized to either immediate multi-vesesl PCI group or culprit-lesion only PCI group with 1:1 ratio. This group will be taken culprit-lesion only PCI during primary PCI. | Procedure or surgery | Culprit-lesion only PCI arm |
| Immediate multi-vessel PCIRandomization will be done after coronary angiography before or during primary PCI for IRA. Patients will be randomized to either immediate multi-vesesl PCI group or culprit-lesion only PCI group with 1:1 ratio. This group will be taken immediate multi-vesesl PCI during primary PCI. | Procedure or surgery | Immediate multi-vesesl PCI arm |
Primary outcome
Rates of all-cause mortality or advanced heart failure requiring cardiac replacement therapy
Time frame: 90 days after primary PCI
all-cause mortality or requiring left ventricular assisted device (LVAD) insertion or heart transplantation)
25 secondary outcomes
Rates of In-hospital mortality
Time frame: Up to 30 days
Rates of In-hospital cardiac mortality
Time frame: Up to 30 days
Rates of VA-ECMO weaning success
Time frame: Up to 30 days
Time to VA-ECMO weaning
Time frame: Up to 30 days
Rates of critical limb ischemia after successful VA-ECMO weaning
Time frame: Up to 30 days
Cerebral Performance Category (CPC) 3-5 at discharge
Time frame: Up to 30 days
Length of intensive-care unit (ICU) stay
Time frame: Up to 30 days
Total procedural time
Time frame: Immediate after the index procedure
Total amount of contrast use
Time frame: Immediate after the index procedure
Rates of all-cause mortality
Time frame: 90 Days and 12 months after primary PCI
Rates of cardiac mortality
Time frame: 90 Days and 12 months after primary PCI
Requirement of cardiac replacement therapy
Time frame: 90 Days and 12 months after primary PCI
Requirement of renal replacement therapy
Time frame: 90 Days and 12 months after primary PCI
Rates of myocardial infarction (MI)
Time frame: 90 Days and 12 months after primary PCI
Rates of MI related to culprit vessel
Time frame: 90 Days and 12 months after primary PCI
Rates of MI related to non-culprit vessel
Time frame: 90 Days and 12 months after primary PCI
Rates of stent thrombosis
Time frame: 90 Days and 12 months after primary PCI
Rates of Re-hospitalization due to heart failure
Time frame: 90 Days and 12 months after primary PCI
Rates of Re-hospitalization due to any cause
Time frame: 90 Days and 12 months after primary PCI
Rates of target-lesion revascularization (TLR)
Time frame: 90 Days and 12 months after primary PCI
Rates of target-vessel revascularization (TVR)
Time frame: 90 Days and 12 months after primary PCI
Rates of repeat revascularization
Time frame: 90 Days and 12 months after primary PCI
Rates of cerebrovascular accident
Time frame: 90 Days and 12 months after primary PCI
Rates of bleeding
Time frame: 90 Days and 12 months after primary PCI
Rates of major bleeding
Time frame: 90 Days and 12 months after primary PCI
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2024.
- Individual participant dataSharing planned: No
Related trials for Cardiogenic Shock
RecruitingObservational study
Evaluation of Acid-base Disorders and Ventilation Settings in Cardiogenic Shock and Post-cardiac Arrest Patients: Comparison With VentilO Algorithm
Cardiac Arrest (CA), Cardiogenic Shock
Not yet recruitingObservational study
Hemodynamic Evaluation of Left Atrial Pressure in Relationship to Pulmonary Capillary Wedge Pressure in Cardio Thoracic Patients
Cardiogenic Shock, Pulmonary Edema Cardiac Cause
Not yet recruitingPhase 4
Capital Offload-Shock
Hypervolemia, Cardiogenic Shock
Recruiting
CRP Apheresis in Infarct-Related Cardiogenic Shock
Cardiogenic Shock, Acute Myocardial Infarction (AMI)
RecruitingObservational study
Cardiogenic Shock Working Group Registry
Cardiogenic Shock
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jeong Hoon Yang, MD principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Culprit lesion only PCI and Immediate multi-vessel PCI in people with Cardiogenic Shock and Acute Myocardial Infarction, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jeong Hoon Yang, MD (82-2-3410-3419, jhysmc@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rates of all-cause mortality or advanced heart failure requiring cardiac replacement therapy (time frame: 90 days after primary PCI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2024.