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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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KCT |
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Last refreshed on:
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12 July 2021 |
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Main ID: |
KCT0006279 |
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Date of registration:
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2021-06-21 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Role of preoperative echocardiography for prevention of cardiovascular event after non-cardiac surgery; Prospective randomized-controlled trial for intermediate risk patients
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Scientific title:
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Role of pre-operative echocardiography for the prevention of cardiovascular accident after non-cardiac surgery (PREOP-ECHO Trial) |
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Date of first enrolment:
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2021-05-26 |
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Target sample size:
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2330 |
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Recruitment status: |
Recruiting |
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URL:
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https://cris.nih.go.kr/cris/search/detailSearchEn.do?seq=19559 |
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Study type:
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Interventional Study |
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Study design:
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Primary Purpose : Prevention, Intervention Model : Parallel, Blinding/Masking : Open, Allocation : RCT
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Phase:
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Not applicable
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Countries of recruitment
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Korea, Republic of
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Contacts
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Name:
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Eui young
Choi |
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Address:
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211, Eonju-ro, Gangnam-gu, Seoul, Republic of Korea
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Telephone:
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+82-2-1599-6114 |
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Email:
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choi0928@yuhs.ac |
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Affiliation:
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Yonsei University Health System, Gangnam Severance Hospital |
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Name:
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Eun Kyoung
Kim |
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Address:
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81, Irwon-ro, Gangnam-gu, Seoul, Republic of Korea
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Telephone:
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+82-2-3410-3419 |
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Email:
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ekbobi.kim@samsung.com |
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Affiliation:
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Samsung Medical Center |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. A patient expected to undergo intermediate-risk non-cardiovascular surgery according to the ESC/AHA guidelines and have two or less clinical cardiovascular risk factors from the revised cardiac risk index.
2. A patient without compelling indication for the echocardiography.
Exclusion criteria: 1. A patient undergoing low-risk or high-risk non-cardiovascular surgery according to the ESC/AHA guidelines.
2. A patient who conducted echocardiography within 3 months from the time of study registration
3. A patient whose life expectancy is less than 6 months.
4. A patient undergoing emergency surgery.
5. Functional capacity < 4 METs
Age minimum:
19?(Year)
Age maximum:
90?(Year)
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Not Applicable
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Intervention(s)
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Others(Echocardiography ) : In ECHO group, the echocardiography according to the standard protocol is performed before the previously scheduled non-cardiovascular surgery, and according to the results, a cardiologist performs appropriate intervention. In non-ECHO group, surgery is performed according to the conventional clinical strategy without an echocardiography before surgery.
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Primary Outcome(s)
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A composite of all-cause death, aborted sudden cardiac arrest, type I myocardial infarction, clinically diagnosed unstable angina, stress-induced cardiomyopathy, lethal arrhythmia such as sustained ventricular tachycardia or ventricular fibrillation, newly diagnosed or acutely decompensated heart failure.
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Secondary Outcome(s)
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cases in which cardiac interventions are necessary before surgery or significant cardiac disease are newly detected.
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A composite of cerebrovascular attack, transient ischemic attack, systemic embolization, pulmonary thromboembolism, type II myocardial infarction, non-lethal arrhythmia such as non-sustained ventricular tachycardia or atrial fibrillation, and change of NT-proBNP.
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Source(s) of Monetary Support
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Ministry of Health & Welfare
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Ethics review
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Status: Submitted approval
Approval date: 13/05/2021
Contact:
Institutional Review Board of Gangnam Severance Hospital
+82-2-2019-4624
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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