An observational study in Stable Angina, Non ST Segment Elevation Myocardial Infarction and ST-segment Elevation Myocardial Infarction, sponsored by Samsung Medical Center. Active, not recruiting at 4 sites in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-14.
Sponsored by Samsung Medical Center · Observational
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Among 30 studies in Angina, Stable with a site in Korea, Republic of — 1 open to participants now, 5 under way, none of them phase 3. Angina, Stable · Korea, Republic of.
Among the 30 studies in Angina, Stable with a site in Korea, Republic of, this one is one of 3 that started in 2017, is one of 6 observational ones, and was the 22nd registered.
343 studies on the registry are indexed under Angina, Stable; 56 are open to participants now.
Browse Angina, Stable studies →1 of the 30 studies in Angina, Stable with a site in Korea, Republic of is open now. Recruiting first, the newest first:
Korea University Guro Hospital · Sites in Korea, Republic of
Ages 19+
A study can be open while its sites in Korea, Republic of have not opened yet or have stopped. Only those recruiting at a site in Korea, Republic of →
Of the 39 Angina, Stable studies recruiting now, 33 (85%) set no upper age limit and 2 (5%) stop at 75 or younger; 2 take children under 18; 1 takes healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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30 studies; the count open now beside each. This study's row is marked.
First in 2008; this study’s year is marked. 3 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 1,200 is above the median of 508 across 103 observational studies indexed under Angina, Stable.
Median enrollment 114 across the 24 interventional studies, 1,199 across the 6 observational. Of the 17 that completed or were terminated, 0 (0%) have results posted.
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6 of 30 have an industry lead sponsor. The 10 most frequent:
Samsung Medical Center is the lead sponsor of 1,011 studies on the registry; 152 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
Samsung Medical Center has 3 studies filed under Angina, Stable — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 30 studies in Angina, Stable with a site in Korea, Republic of, from their registry updates:
Nothing recorded among them since 2026-09-25.
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The current study sought to evaluate the clinical relevance of iFR-guided strategy in real world clinical practice using unrestricted study population from stable angina to acute coronary syndrome including acute ST-segment elevation myocardial infarction. Previous abundant historical data of FFR-guided strategy will be also included as historical control to validate the iFR-guided strategy.
In this study, the investigators will validate the clinical relevance of instantaneous wave free ratio (iFR)-guided strategy in real world clinical practice in Korea. The 1,200 patients who underwent iFR measurement will be prospectively enrolled at 5 centers in Republic of Korea. In patients who were indicated revascularization after iFR measurement (iFR\<0.90), iFR pullback system (iFR Scout) and post-revascularization iFR measurement will be routinely performed. The primary hypothesis will be tested for non-inferiority of iFR-guided strategy, compared with FFR-guided strategy in terms of 2-year clinical outcomes. For the clinical outcome data following FFR-guided strategy will be used from the pooled data of the DEFER-DES trial, the 3V FFR FRIENDS registry (NCT01621438), and Korean 4-center FFR registry. Using those data, 1200 patients will be selected from the pooled data. In addition, routine application of iFR Scout and post-revascularization iFR measurement will enable us to validate the clinical relevance of iFR-based prediction of acute procedural results and to compare FFR-pullback methods.
Primary Hypothesis: The iFR-guided strategy will be non-inferior regarding patient-oriented composite outcomes (a composite of any death, any MI, any revascularization) at 2-year, compared with FFR-guided strategy.
Primary Outcome:
1] Patient-oriented composite outcome (POCO), defined as a composite of any death, any myocardial infarction (MI) or any revascularization at 2-year after index procedure according to the ARC consensus [2] Difference between Predicted post-PCI iFR value from iFR Scout and Actual post-PCI iFR measurement
Sample Size 1,200 patients with suspected ischemic heart disease including stable angina, or acute coronary syndrome including unstable angina, non ST-segment elevation MI, or ST-segment elevation MI with non-culprit stenosis enrolled at 5 centers in Republic of Korea.
Inclusion Criteria
① Subject must be ≥18 years
② Patients suspected with ischemic heart disease
③ Patients with coronary artery stenosis with intermediate degree of stenosis (40-70% stenosis by visual estimation) in major epicardial coronary artery amenable to stent implantation or vessel size≥2.5 mm without definitive previous evidence of myocardial ischemia.
④ Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving invasive physiologic evaluation and he/she or his/her legally authorized representative provides
Exclusion criteria
Cardiogenic shock (systolic blood pressure \< 90mmHg or requiring inotropics to maintain blood pressure > 90mmHg) ② Patients with a known hypersensitivity or contraindication to any of the following medications: statin, ezetimibe, heparin, aspirin, clopidogrel, prasugrel, ticagrelor
Non-cardiac co-morbid conditions are present with life expectancy \<2 year (per site investigator's medical judgment).
1,200 patients with suspected ischemic heart disease including stable angina, or acute coronary syndrome including unstable angina, non ST-segment elevation MI, or ST-segment elevation MI with non-culprit stenosis who underwent iFR measurement and enrolled at 5 centers in Republic of Korea.
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Subject must be ≥18 years
Patients suspected with ischemic heart disease ③ Patients with coronary artery stenosis with intermediate degree of stenosis (40-70% stenosis by visual estimation) in major epicardial coronary artery amenable to stent implantation or vessel size≥2.5 mm without definitive previous evidence of myocardial ischemia.
Exclusion Criteria:
Cardiogenic shock (systolic blood pressure \< 90mmHg or requiring inotropics to maintain blood pressure > 90mmHg)
Patients with a known or to any of the following medications: statin, ezetimibe, heparin, aspirin, clopidogrel, prasugrel, ticagrelor ③ Non-cardiac co-morbid conditions are present with \<2 year (per site investigator's medical judgment).
History of bleeding diathesis, known coagulopathy (including heparin-induced thrombocytopenia)
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
1,200 patients with suspected ischemic heart disease including stable angina, or acute coronary syndrome including unstable angina, non ST-segment elevation MI, or ST-segment elevation MI with non-culprit stenosis who underwent iFR measurement and enrolled at 5 centers in Republic of Korea.
Other: Instantaneous wave-free ratio measurement
Instantaneous wave-free ratio measurement in order to evaluate functional significance of epicardial stenosis
Patient-oriented composite outcome (POCO)
a composite of any death, any myocardial infarction (MI) or any revascularization according to the ARC consensus
Time frame: at 2-year after index procedure
Difference between Predicted post-PCI iFR value from iFR Scout and Actual post-PCI iFR measurement
Difference between Predicted post-PCI iFR value from iFR Scout and Actual post-PCI iFR measurement
Time frame: Immediate after post revascularization
Plan to share: Undecided — Data will be shared upon request after thorough discussion in steering committee
No publications or documents are linked to this record.
Started Nov 2017 (actual). Primary completion is estimated for Dec 2025, 97 months after the start.
Of 52 observational studies under Angina, Stable, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 79. This study's planned 97 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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