Clinical Outcomes and Efficacy of Left Ventricular Assist Device for Korean Patients With Cardiogenic Shock (SMART-RESCUE)
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|ClinicalTrials.gov Identifier: NCT02985008|
Recruitment Status : Unknown
Verified December 2016 by Jeong Hoon Yang, Samsung Medical Center.
Recruitment status was: Recruiting
First Posted : December 7, 2016
Last Update Posted : December 7, 2016
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|Condition or disease|
- The selection / exclusion criteria for persons with cardiogenic shock should be verified by medical records from January 1, 2014 before the approval date of each institution's clinical trial screening committee.
- If a cardiogenic shock to the selection criteria is found in the emergency room, general ward, or intensive care unit of the participating institutions, enroll in this study and fill in the information according to the e-CRF.
- After 1, 6 and 12 months, visit the hospital for examination and procedures. The person in charge of the examination or the delegate of the examiner may follow the person by telephone or an outpatient visit.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||1000 participants|
|Target Follow-Up Duration:||1 Year|
|Official Title:||SMart Angioplasty Research Team: A Multi-center, Open, REtrospective and Prospective Observational Study to Investigate Clinical oUtcomes and Efficacy of Left Ventricular Assist Device for Korean Patients With Cardiogenic Shock : RESCUE|
|Study Start Date :||April 2016|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
- In hospital death [ Time Frame: for 1 year ]
- Death in 28days [ Time Frame: 28days ]
- Death in 1 year [ Time Frame: 1 year ]
- Death, myocardial infarction, stroke, re-admission due to heart failure during follow-up. [ Time Frame: 1 year ]
- Number of days of intensive care unit Number of days of intensive care unit [ Time Frame: 1 year ]
- hospitalization days [ Time Frame: 1 year ]
- Lactate 24 hour clearance [ Time Frame: 1 year ]
- Successful removal of left ventricular assist device (IABP, ECMO) [ Time Frame: 1 year ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||19 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Probability Sample|
- Cardiogenic shock group with inserted IABP, ECMO : 400
- Cardiogenic shock group without inserted IABP, ECMO : 600
- 19 years old or older
① Systolic blood pressure is less than 90mmHg for more than 30 minutes despite the fluid therapy, or Use of pressure boosting agents is necessary.
② Peripheral hypopnea (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 acute myocardial infarction (including in coronary intervention), cardiomyopathy, myocarditis, pulmonary embolism, refractory ventricular tachycardia, shock during coronary intervention.
- Those voluntarily consenting to the medical records and the data necessary for the study during the entire study period.
- Other causes except for cardiogenic shock (low blood pressure, septic, obstructive shock)
- Shock with cardiac arrest outside the hospital
- People with allergic reactions to anticoagulants such as heparin.
- Those who refused active treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02985008
|Contact: Jeong Hoon Yangemail@example.com|
|Contact: Jin Hee Seofirstname.lastname@example.org|
|Korea, Republic of|
|Samsung Medical Center||Recruiting|
|Seoul City, Seoul, Korea, Republic of, KS013|
|Contact: Jeong Hoon Yang email@example.com|
|Study Chair:||Jeong Hoon Yang||Samsung Medical Center|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Jeong Hoon Yang, Professor, Samsung Medical Center|
|Other Study ID Numbers:||
|First Posted:||December 7, 2016 Key Record Dates|
|Last Update Posted:||December 7, 2016|
|Last Verified:||December 2016|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
Shock, IVBP, ECMO, In hospital death