Pragmatic Trial Comparing Symptom-Oriented Versus Routine Stress Testing in High-Risk Patients Undergoing Percutaneous Coronary Intervention
NCT ID: NCT03217877
Last Updated: 2022-04-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1700 participants
INTERVENTIONAL
2017-11-15
2021-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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No Routine stress testing after PCI
No Routine stress testing
In the group of symptom oriented stress testing group, the preselected functional test (exercise ECG, nuclear stress testing, or stress echocardiography) will be performed when chest pain or angina symptom is occured after the procedure according to the practice pattern of each participating center.
Routine stress testing at 9~15 months after PCI
routine stress testing
In the group of routine stress testing group, the preselected functional test (exercise ECG, nuclear stress testing, or stress echocardiography) will be performed at 9\~15 months after the procedure according to the practice pattern of each participating center.
Interventions
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routine stress testing
In the group of routine stress testing group, the preselected functional test (exercise ECG, nuclear stress testing, or stress echocardiography) will be performed at 9\~15 months after the procedure according to the practice pattern of each participating center.
No Routine stress testing
In the group of symptom oriented stress testing group, the preselected functional test (exercise ECG, nuclear stress testing, or stress echocardiography) will be performed when chest pain or angina symptom is occured after the procedure according to the practice pattern of each participating center.
Eligibility Criteria
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Inclusion Criteria
2. Subjects who underwent successful percutaneous coronary intervention with contemporary drug eluting stent, contemporary Bioresorbable Scaffold or drug eluting balloon at In-stent restenosis (ISR) lesion.
3. Patients must have at least one of the following high-risk clinical, lesion, or procedure-related risk factors.
3-1. Clinical factors; diabetes, renal insufficiency/failure, enzyme positive acute coronary syndrome (ACS) (STEMI or NSTEMI).
3-2. Lesion- or procedure-related factors ; left main lesion, bifurcation lesion, ostial lesion, chronic total occlusion lesion, multivessel disease (≥ 2 vessels stented), restenotic lesion, diffuse long lesion (lesion length ≥30 mm or stent length ≥32 mm), or vein bypass graft stented
4. The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.
Exclusion Criteria
2. Subject treated with only bare metal stent or balloon angioplasty during the index procedure.
3. Pregnant and/or lactating women.
4. Concurrent medical condition with a life expectancy of less than 1 years
5. Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
6 Subject was unable to provide written informed consent or participate in long-term follow-up.
20 Years
ALL
No
Sponsors
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CardioVascular Research Foundation, Korea
OTHER
Seung-Jung Park
OTHER
Responsible Party
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Seung-Jung Park
professor
Principal Investigators
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Duk-woo Park, MD
Role: PRINCIPAL_INVESTIGATOR
Asan Medical Center
Locations
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Gangwon National Univ. Hospital
Chuncheon, , South Korea
Daegu Catholic University Medical Center
Daegu, , South Korea
Keimyung University Dongsan Medical Center
Daegu, , South Korea
Chungnam National University Hospital
Daejeon, , South Korea
Bundang CHA Hospital
Seongnam, , South Korea
Seoul National University Bundang hospital
Seongnam, , South Korea
Asan Medical Center
Seoul, , South Korea
Eulji General Hospital
Seoul, , South Korea
The Catholic University of Korea, Yeouido St. Mary's Hospital
Seoul, , South Korea
The Catholic university of Korea, ST. Vincent's Hospital
Suwon, , South Korea
Wonju Severance Christian Hospital
Wŏnju, , South Korea
Countries
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References
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Choi Y, Kang DY, Kim H, Lee J, Jo S, Ahn JM, Kim N, Yoon YH, Hur SH, Lee CH, Kim WJ, Kang SH, Park CS, Lee BK, Suh JW, Choi JW, Kim KS, Lee SN, Park SJ, Park DW; POST-PCI Investigators. Role of routine surveillance stress testing in patients with or without imaging-guided or physiology-guided PCI. Heart. 2025 Oct 2:heartjnl-2025-326402. doi: 10.1136/heartjnl-2025-326402. Online ahead of print.
Lee J, Kang DY, Kim H, Choi Y, Jo S, Ahn JM, Kim S, Yoon YH, Hur SH, Lee CH, Kim WJ, Kang SH, Park CS, Lee BK, Suh JW, Choi JW, Kim KS, Lee SN, Park SJ, Park DW. Routine Stress Testing After PCI in Patients With and Without Acute Coronary Syndrome: A Secondary Analysis of the POST-PCI Randomized Clinical Trial. JAMA Cardiol. 2024 Sep 1;9(9):770-780. doi: 10.1001/jamacardio.2024.1556.
Lee JM, Kim H, Park YS, Jo HH, Lim SM, Lee J, Choi Y, Kang DY, Ahn JM, Kim S, Yoon YH, Hur SH, Lee CH, Kim WJ, Kang SH, Park CS, Lee BK, Suh JW, Choi JW, Kim KS, Lee SN, Park SJ, Park DW; POST-PCI Investigators. Surveillance Stress Testing After Percutaneous Intervention for Patients With Multivessel or Left Main Coronary Disease. J Am Coll Cardiol. 2024 Mar 5;83(9):890-900. doi: 10.1016/j.jacc.2023.12.027.
Park DW, Kang DY, Ahn JM, Yun SC, Yoon YH, Hur SH, Lee CH, Kim WJ, Kang SH, Park CS, Lee BK, Suh JW, Yoon JH, Choi JW, Kim KS, Choi SW, Lee SN, Park SJ; POST-PCI Investigators. Routine Functional Testing or Standard Care in High-Risk Patients after PCI. N Engl J Med. 2022 Sep 8;387(10):905-915. doi: 10.1056/NEJMoa2208335. Epub 2022 Aug 28.
Other Identifiers
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AMCCV2017-05
Identifier Type: -
Identifier Source: org_study_id
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