Cardiogenic ShockRESCUE IINCT04143893
The Current Status and Clinical Outcomes of Patients With Cardiogenic Shock II
An observational study of Cardiogenic Shock, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The investigation of patient characteristics and prognostic factors of the patients presented with cardiogenic shock (CS) will guide us to identify the better management strategy for these critically ill patients. Mechanical circulatory support (MCS) may improve the prognosis of some of severe subset of CS patients. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Cardiogenic Shock
- What is being tested?
- Mechanical circulatory support and Optimal medical treatment
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 May 2019to 31 Dec 2024
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: About 1000 patient with cardiogenic shock
Who may be able to join
- 19 years old or older
- Cardiogenic shock is defined as the presence of the following:
- Systolic blood pressure is less than 90mmHg for more than 30 minutes despite the fluid therapy, or the use of pressure boosting agents to maintain the systolic blood pressure more than 90 mmHg.
- Peripheral hypoperfusion (cold skin, urine less than 30 cc per hour, impaired consciousness, lactate ≥2.0 mmol/l) or a person with pulmonary edema.
- Causes of cardiogenic shock include ischemic (acute myocardial infarction or ischemic cardiomyopathy, shock during cardiac intervention), myocardial (end-stage heart failure, myocarditis), post-cardiotomy shock, cardiac tamponade, or pulmonary thromboembolism.
- Those voluntarily consenting to the medical records and the data necessary for the study during the entire study period.
Who cannot join
- Other causes except for cardiogenic shock: septic shock, cardiac arrest by serious ventricular arrhythmia not related to the myocardial ischemia or heart failure
- Shock with unwitnessed cardiac arrest outside the hospital
- Severe non-cardiac morbidity with expected survival less than 6 months (malignancy, respiratory failure)
- Those who refused active treatment
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, 06351
Jeong Hoon Yang, MD, PhD, 82-2-3410-3419, jhysmc@gmail.com
Ki Hong Choi, MD, 82-10-8875-1648, cardiokh@gmail.com
About this study
Official title: SMart Angioplasty Research Team: A Multi-centeR, prospEctive Observational Study to Investigate the Current Status and Clinical oUtcomes of Patients With cardiogEnic Shock II: SMART-RESCUE II
The investigation of patient characteristics and prognostic factors of the patients presented with cardiogenic shock (CS) will guide us to identify the better management strategy for these critically ill patients. Mechanical circulatory support (MCS) may improve the prognosis of some of severe subset of CS patients. The better understanding of the indications of initiation and weaning of MCS will improve the prognosis of critically ill CS patients.
Read the detailed description
Patients presented with cardiogenic shock (CS) still have a very poor prognosis with high in-hospital mortality even in current era of medical practice. Acute myocardial infarction (AMI) complicated by CS has been associated with is an in-hospital survival of around 50% historically. Recent development of mechanical circulatory support (MCS) showed a better survival in the patients who would have been associated with a very high mortality in conventional medical treatment. Still the most of the management strategy for this critically ill patient subset is empirical and mostly not based on scientific evidence. There have been few randomized controlled trials and well-designed registries have been rare.
Recent randomized controlled trial, IABP SHOCK II trial showed that use of IABP did not improve survival in CS patients complicating AMI. With the FDA approval of Impella in CS patients, a powerful new tool has become available for hemodynamic support. Impella is a transcatheter axial flow pump, delivered percutaneous, with the ability to provide 2.5 to 4.0 liters/minute of forward flow. In some countries where Impella is not available, extracorporeal membrane oxygenator (ECMO) has been widely used in patients with cardiac arrest or CS. ECMO is equipped with an oxygenator and may be more beneficial in the patients with cardiac and pulmonary failure. Impella is a more physiological device that does not compete with native blood flow. However, there is little data available to providers as to the best practice patterns associated with the delivery and use of mechanical circulatory devices in CS patients, furthermore, no data regarding CS patients originated by non-ischemic and post-cardiotomy situation as an etiology of cardiogenic shock.
Around 20 years ago, it is conducted CS registry and then, Cardshock registry launched in 2010 and enrolled only 219 patients. Well-designed large scale registries of CS patients are scarce. Recently, the investigators conducted retrospective and prospective registry of patient with cardiogenic shock (RESCUE I registry) and just finished to enroll 1247 patients from 12 centers in Korea between January 2014 and December 2018. ECMO device was used in 496 patients (40%) and IABP was used in 298 patients (24%). The registry is under analysis to investigate clinical characteristics and predictors of in-hospital mortality. The major weakness of RESCUE I registry are ;1) major proportion of the patients were enroll retrospectively, 2) the etiology of shock was not well defined, and most of enrolled population were of ischemic etiology, 3) the variables in the case record form was not systematically structured. Based on the RESCUE I registry, the investigators would like to launch RESCUE II registry as an prospective registry with well-defined subgroups of ischemic, myocardial, post-cardiotomy etiologies, and more systematically arranged variables based on prospective protocols or guidelines of management based on RESCUE I registry.
The investigators believe that the differences of races, management, and difference types of MCS can influence the outcomes of CS patients, but still there were no evidence. Mayo clinic is one of the top medical centers of excellence with experiences and science in the field of critically ill patients. The collaboration of Mayo Clinic team and RESCUE research team in Korea will be quite synergistic by sharing their knowledge and experience in the management and research in this filed.
The ultimate goal of RESCUE II is to develop the evidence-based medicine for the patients with cardiogenic shock by bringing experienced centers together across the 2 nations who are experts in mechanical circulatory support devices as well as the medical management in critically ill CS patients. The investigators aim to find optimal monitoring strategy, medical management, as well as best protocols for the application of mechanical circulatory support.
- Conditions
- Cardiogenic Shock
- Being tested
- Mechanical circulatory support, Optimal medical treatment
- Keywords
- Cardiogenic shock, Mechanical Circulatory Support
- Medical subject headings
- Shock, Cardiogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical circulatory supportDevice
Patients with cardiogenic shock who underwent MCS
Optimal medical treatmentDrug
Patients with cardiogenic shock who received optimal medical treatment including vasopressor
| Study group | Role | What they receive |
|---|---|---|
| Cardiogenic shock with MCS | Patients with cardiogenic shock who underwent MCS Receives: Device: Mechanical circulatory support; Drug: Optimal medical treatment | |
| Cardiogenic shock without MCS | Patients with cardiogenic shock who did not undergo MCS Receives: Drug: Optimal medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-hospital all-cause mortality
Death in-hospital
Measured: Up to 12 weeks
Secondary outcomes (7)
In-hospital cardiac mortality
Cardiac death in-hospital
Measured: Up to 12 weeks
In-hospital neurologic outcome
Defined by the cerebral performance category (CPC) scoring system (ranges from 1 to 5 / good outcome as a CPC score of 1 or 2, and a poor outcome [severe neurological disability, persistent vegetative state or death] as CPC scores 3, 4, or 5)
Measured: Up to 12 weeks
Death in 30days
30 Days mortality
Measured: 30 Days after admission
Cardiac death in 30 days
30 Days cardiac mortality
Measured: 30 Days after admission
MACE
Death, myocardial infarction, stroke, re-admission due to heart failure, and heart transplantation during follow-up.
Measured: through study completion, an average of 1 year
Lactate clearance
Lactate 24 hour clearance
Measured: 24 hours after admission
Successful weaning of mechanical circulatory support device
In-hospital successful weaning of mechanical circulatory support device, including IABP, Impella, and ECMO. (successful weaning or failed weaning)
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2019
- Study start30 May 2019
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyeon-Cheol Gwon, Samsung Medical Center
- Investigators
- Hyeon-Cheol Gwon, MD,PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04143893
- Sponsor's protocol ID
- RESCUEII
- Acronym
- RESCUE II
- Status last verified
- Oct 2019
- First submitted
- 23 Oct 2019
- Last updated
- 1 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SMart Angioplasty Research Team: A Multi-centeR, prospEctive Observational Study to Investigate the Current Status and Clinical oUtcomes of Patients With cardiogEnic Shock II: SMART-RESCUE II
- ClinicalTrials.gov ID
- NCT04143893
- Acronym / sponsor ID
- RESCUE II / RESCUEII
- Conditions
- Cardiogenic Shock
- Keywords
- Cardiogenic shock, Mechanical Circulatory Support
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 30 May 2019 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 29 Oct 2019 (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.
The investigation of patient characteristics and prognostic factors of the patients presented with cardiogenic shock (CS) will guide us to identify the better management strategy for these critically ill patients. Mechanical circulatory support (MCS) may improve the prognosis of some of severe subset of CS patients. The better understanding of the indications of initiation and weaning of MCS will improve the prognosis of critically ill CS patients.
Detailed description
Patients presented with cardiogenic shock (CS) still have a very poor prognosis with high in-hospital mortality even in current era of medical practice. Acute myocardial infarction (AMI) complicated by CS has been associated with is an in-hospital survival of around 50% historically. Recent development of mechanical circulatory support (MCS) showed a better survival in the patients who would have been associated with a very high mortality in conventional medical treatment. Still the most of the management strategy for this critically ill patient subset is empirical and mostly not based on scientific evidence. There have been few randomized controlled trials and well-designed registries have been rare.
Recent randomized controlled trial, IABP SHOCK II trial showed that use of IABP did not improve survival in CS patients complicating AMI. With the FDA approval of Impella in CS patients, a powerful new tool has become available for hemodynamic support. Impella is a transcatheter axial flow pump, delivered percutaneous, with the ability to provide 2.5 to 4.0 liters/minute of forward flow. In some countries where Impella is not available, extracorporeal membrane oxygenator (ECMO) has been widely used in patients with cardiac arrest or CS. ECMO is equipped with an oxygenator and may be more beneficial in the patients with cardiac and pulmonary failure. Impella is a more physiological device that does not compete with native blood flow. However, there is little data available to providers as to the best practice patterns associated with the delivery and use of mechanical circulatory devices in CS patients, furthermore, no data regarding CS patients originated by non-ischemic and post-cardiotomy situation as an etiology of cardiogenic shock.
Around 20 years ago, it is conducted CS registry and then, Cardshock registry launched in 2010 and enrolled only 219 patients. Well-designed large scale registries of CS patients are scarce. Recently, the investigators conducted retrospective and prospective registry of patient with cardiogenic shock (RESCUE I registry) and just finished to enroll 1247 patients from 12 centers in Korea between January 2014 and December 2018. ECMO device was used in 496 patients (40%) and IABP was used in 298 patients (24%). The registry is under analysis to investigate clinical characteristics and predictors of in-hospital mortality. The major weakness of RESCUE I registry are ;1) major proportion of the patients were enroll retrospectively, 2) the etiology of shock was not well defined, and most of enrolled population were of ischemic etiology, 3) the variables in the case record form was not systematically structured. Based on the RESCUE I registry, the investigators would like to launch RESCUE II registry as an prospective registry with well-defined subgroups of ischemic, myocardial, post-cardiotomy etiologies, and more systematically arranged variables based on prospective protocols or guidelines of management based on RESCUE I registry.
The investigators believe that the differences of races, management, and difference types of MCS can influence the outcomes of CS patients, but still there were no evidence. Mayo clinic is one of the top medical centers of excellence with experiences and science in the field of critically ill patients. The collaboration of Mayo Clinic team and RESCUE research team in Korea will be quite synergistic by sharing their knowledge and experience in the management and research in this filed.
The ultimate goal of RESCUE II is to develop the evidence-based medicine for the patients with cardiogenic shock by bringing experienced centers together across the 2 nations who are experts in mechanical circulatory support devices as well as the medical management in critically ill CS patients. The investigators aim to find optimal monitoring strategy, medical management, as well as best protocols for the application of mechanical circulatory support.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cardiogenic shock with MCS | – | Device: Mechanical circulatory support, Drug: Optimal medical treatmentPatients with cardiogenic shock who underwent MCS |
| Cardiogenic shock without MCS | – | Drug: Optimal medical treatmentPatients with cardiogenic shock who did not undergo MCS |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- About 1000 patient with cardiogenic shock
Key inclusion criteria (6 listed)
- 19 years old or older
- Cardiogenic shock is defined as the presence of the following:
- Causes of cardiogenic shock include ischemic (acute myocardial infarction or ischemic cardiomyopathy, shock during cardiac intervention), myocardial (end-stage heart failure, myocarditis), post-cardiotomy shock, cardiac tamponade, or pulmonary thromboembolism.
- Those voluntarily consenting to the medical records and the data necessary for the study during the entire study period.
Key exclusion criteria (4 listed)
- Other causes except for cardiogenic shock: septic shock, cardiac arrest by serious ventricular arrhythmia not related to the myocardial ischemia or heart failure
- Shock with unwitnessed cardiac arrest outside the hospital
- Severe non-cardiac morbidity with expected survival less than 6 months (malignancy, respiratory failure)
- Those who refused active treatment
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 |
|---|---|---|
| Mechanical circulatory supportPatients with cardiogenic shock who underwent MCS | Device | Cardiogenic shock with MCS |
| Optimal medical treatmentPatients with cardiogenic shock who received optimal medical treatment including vasopressor | Drug | Cardiogenic shock with MCS, Cardiogenic shock without MCS |
Primary outcome
In-hospital all-cause mortality
Time frame: Up to 12 weeks
Death in-hospital
7 secondary outcomes
In-hospital cardiac mortality
Time frame: Up to 12 weeks
In-hospital neurologic outcome
Time frame: Up to 12 weeks
Death in 30days
Time frame: 30 Days after admission
Cardiac death in 30 days
Time frame: 30 Days after admission
MACE
Time frame: through study completion, an average of 1 year
Lactate clearance
Time frame: 24 hours after admission
Successful weaning of mechanical circulatory support device
Time frame: Up to 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2019.
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. This study is not recruiting at the moment.
Hyeon-Cheol Gwon, MD,PhD 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?
An observational study of Cardiogenic Shock, 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 6 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 1 Nov 2019. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jeong Hoon Yang, MD, PhD (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?
In-hospital all-cause mortality (time frame: Up to 12 weeks). 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 1 Nov 2019.