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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
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.

Jeong Hoon Yang, MD contact

82-2-3410-3419

jhysmc@gmail.com

Ki Hong Choi, MD contact

82-2-3410-6653

cardiokh@gmail.com

South Korea1 site, 1 recruiting
  • Samsung Medical Center

    Seoul, 06351

    Jeong Hoon Yang, MD, 82-2-3410-3419, jhysmc@gmail.com

    Recruiting

Other trials in South Korea

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).

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 groups in NCT05527717
Study groupRoleWhat they receive
Culprit-lesion only PCI armActive comparatorPatients will receive culprit-lesion only PCI.
Receives: Procedure: Culprit lesion only PCI
Immediate multi-vesesl PCI armExperimentalPatients 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.

  1. 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)
  1. Rates of In-hospital mortality

    Death by any cause in hospital

    Measured: Up to 30 days

  2. Rates of In-hospital cardiac mortality

    Death by cardiac cause in hospital

    Measured: Up to 30 days

  3. 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

  4. Time to VA-ECMO weaning

    Time from VA-ECMO insertion to VA-ECMO weaning

    Measured: Up to 30 days

  5. 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

  6. Cerebral Performance Category (CPC) 3-5 at discharge

    Neurologic performance scale at discharge

    Measured: Up to 30 days

  7. Length of intensive-care unit (ICU) stay

    ICU stay day

    Measured: Up to 30 days

  8. Total procedural time

    Procedural time (minutes)

    Measured: Immediate after the index procedure

  9. Total amount of contrast use

    Contrast use (cc)

    Measured: Immediate after the index procedure

  10. Rates of all-cause mortality

    Death by any cause

    Measured: 90 Days and 12 months after primary PCI

  11. Rates of cardiac mortality

    Death by cardiac cause

    Measured: 90 Days and 12 months after primary PCI

  12. Requirement of cardiac replacement therapy

    LVAD insertion or heart transplantation

    Measured: 90 Days and 12 months after primary PCI

  13. Requirement of renal replacement therapy

    Continuous renal replacement therapy, hemodialysis, or peritoneal dialysis

    Measured: 90 Days and 12 months after primary PCI

  14. Rates of myocardial infarction (MI)

    spontaneous MI during follow-up

    Measured: 90 Days and 12 months after primary PCI

  15. Rates of MI related to culprit vessel

    MI related to culprit vessel during follow-up

    Measured: 90 Days and 12 months after primary PCI

  16. 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

  17. Rates of stent thrombosis

    Academic Research Consortium (ARC)-defined definite or probable stent thrombosis

    Measured: 90 Days and 12 months after primary PCI

  18. 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

  19. 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

  20. Rates of target-lesion revascularization (TLR)

    TLR during follow-up

    Measured: 90 Days and 12 months after primary PCI

  21. Rates of target-vessel revascularization (TVR)

    TVR during follow-up

    Measured: 90 Days and 12 months after primary PCI

  22. Rates of repeat revascularization

    Repeat revascularization during follow-up

    Measured: 90 Days and 12 months after primary PCI

  23. Rates of cerebrovascular accident

    Cerebrovascular accident during follow-up

    Measured: 90 Days and 12 months after primary PCI

  24. Rates of bleeding

    Bleeding ARC [BARC] type 2, 3, or 5

    Measured: 90 Days and 12 months after primary PCI

  25. 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.

  1. First posted2 Sep 2022
  2. Study start16 Nov 2022
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

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)
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

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.

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