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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Jeong Hoon Yang, MD, PhD contact

82-2-3410-3419

jhysmc@gmail.com

Ki Hong Choi, MD contact

82-10-8875-1648

cardiokh@gmail.com

South Korea1 site, 1 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

    Recruiting

Other trials in South Korea

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.

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 groups in NCT04143893
Study groupRoleWhat they receive
Cardiogenic shock with MCSPatients with cardiogenic shock who underwent MCS
Receives: Device: Mechanical circulatory support; Drug: Optimal medical treatment
Cardiogenic shock without MCSPatients 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.

  1. In-hospital all-cause mortality

    Death in-hospital

    Measured: Up to 12 weeks

Secondary outcomes (7)
  1. In-hospital cardiac mortality

    Cardiac death in-hospital

    Measured: Up to 12 weeks

  2. 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

  3. Death in 30days

    30 Days mortality

    Measured: 30 Days after admission

  4. Cardiac death in 30 days

    30 Days cardiac mortality

    Measured: 30 Days after admission

  5. 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

  6. Lactate clearance

    Lactate 24 hour clearance

    Measured: 24 hours after admission

  7. 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.

  1. First posted29 Oct 2019
  2. Study start30 May 2019
  3. Primary completion31 Dec 2023 (estimated)
  4. Study completion31 Dec 2024 (estimated)

Resources

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
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

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.

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