ST Elevation Myocardial InfarctionFRAME-AMI2NCT05812963
IVUS Versus FFR for Non-infarct Related Artery Lesions in Patients With Multivessel Disease and Acute MI
A study testing IVUS-guided PCI group and FFR-guided PCI group in people with ST Elevation Myocardial Infarction and Non-ST Elevation Myocardial Infarction, run by Samsung Medical Center at 2 sites in South Korea.
Trial summary
The aim of the study is to compare clinical outcomes between intravascular ultrasound (IVUS)-guided treatment decision versus fractional flow reserve (FFR)-guided treatment decision for non-infarct related artery stenosis in patients with acute myocardial infarction (AMI) and multivessel disease. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- ST Elevation Myocardial Infarction, Non-ST Elevation Myocardial Infarction
- What is being tested?
- IVUS-guided PCI group and FFR-guided PCI group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,400 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 18 Sep 2023to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Subject must be at least 19 years of age
- Acute ST-segment elevation myocardial infarction (STEMI)
- STEMI: ST-segment elevation ≥0.1 mV in ≥2 contiguous leads or documented newly developed left bundle-branch block
- Acute non-ST-segment elevation myocardial infarction (NSTEMI)
- NSTEMI: NSTEMI is defined as a combination of criteria with mandated elevation of a cardiac biomarker, preferably high-sensitive cardiac troponin with at least one value above 99th percentile of the upper reference limit and at least one of the following:
- Symptoms of ischemia.
Show all 13Show fewer
- New or presumed new significant ST-T wave changes
- Development of pathological Q waves on electrocardiography.
- Imaging evidence of new or presumed new loss of viable myocardium or regional wall motion abnormality.
- Intracoronary thrombus detected on angiography.
- Successful primary percutaneous coronary intervention (PCI) in < 12 h after the onset of symptoms for STEMI patients (In case of NSTEMI, PCI should be performed within 72 hours of symptom onset)
- Multivessel disease (at least one stenosis of >50% in a non-IRA ≥2.25 mm by visual estimation)
- Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving invasive physiologic evaluation and PCI and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.
Who cannot join
- Non-IRA stenosis not amenable for PCI treatment by operators' decision
- Cardiogenic shock (Killip class IV) already at presentation or the completion of IRA PCI
- Intolerance to Aspirin, Clopidogrel, Prasugrel, Ticagrelor, Heparin, or Everolimus
- Known true anaphylaxis to contrast medium (not allergic reaction but anaphylactic shock)
- Pregnancy or breast feeding
- Non-cardiac co-morbid conditions are present with life expectancy <2 year or that may result in protocol non-compliance (per site investigator's medical judgment)
- Other primary valvular disease with severe degree: severe mitral regurgitation, mitral stenosis, severe aortic regurgitation, or aortic stenosis
- Unwillingness or inability to comply with the procedures described in this protocol.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea2 sites, 2 recruiting
- Not yet recruiting
Chonnam National University
Gwangju
Young Joon Hong, MD, PhD, hyj200@hanmail.net
Seung Hun Lee, MD, PhD, lsh8602@naver.com
- Recruiting
Samsung Medical Center
Seoul
Joo Myung Lee, MD, MPH, PhD, 82-2-3410-2575, drone80@hanmal.net
Joo-Yong Hahn, MD, PhD, 82-2-3410-2575, jooyong.hahn@gmail.com
About this study
Official title: Randomized Controlled Trial of Intravascular Ultrasound Versus Fractional Flow Reserve for Non-infarct Related Artery Lesions in Patients With Multivessel Disease and Acute Myocardial Infarction
The aim of the study is to compare clinical outcomes between intravascular ultrasound (IVUS)-guided treatment decision versus fractional flow reserve (FFR)-guided treatment decision for non-infarct related artery stenosis in patients with acute myocardial infarction (AMI) and multivessel disease.
Read the detailed description
The treatment of choice of acute myocardial infarction (AMI) including ST-segment elevation myocardial infarction (STEMI) and non-ST segment elevation myocardial infarction (NSTEMI) is reperfusion therapy, preferably with percutaneous coronary intervention (PCI). While need of treating the infarct related artery (IRA) is obvious, need for routine revascularization of non-infarct related artery (non-IRA) has been a topic of debate until recent years. Through a number of observational studies, randomized trials and meta-analyses, the benefits of non-IRA PCI have been continuously implied, and COMPLETE trial with 4041 patients of STEMI and multivessel coronary artery disease in 2019 demonstrated superiority of complete revascularization to culprit-only PCI in terms of cardiovascular death or MI (primary end point) and cardiovascular death, MI, or ischemia-driven revascularization (co-primary end point). As such, complete revascularization of a significant non-IRA stenosis is recommended after successful PCI for IRA in patients with AMI and multivessel disease in current clinical guidelines.
Nevertheless, it has been unclear which criteria should be used to decide non-IRA PCI. Although potential significance of non-IRA lesions can be estimated by angiography, the limitation of angiographic visual assessment or quantitative coronary angiography has been well known. Various measurements are used for incremental information in addition to angiographic assessment in guiding PCI - namely, intravascular ultrasound (IVUS) and fractional flow reserve (FFR). IVUS provides anatomical information regarding the lumen, plaque, and plaque characteristics, and can optimize stent placement minimizing stent-related problems and lead to better clinical outcomes. On the other hand, FFR provides information on amount of ischemia which the stenosis in question is causing, and also improves the quality of PCI which has been demonstrated by multiple previous trials, and current practice guidelines recommend the use of FFR to determine revascularization strategy as Class IA recommendation. Recent trials evaluated comparative prognosis between FFR-guided versus angiograph-guided PCI for non-IRA in patients with acute MI and multivessel disease. FLOWER-MI trial showed comparable clinical outcome between FFR-guided versus angiography-guided PCI for non-IRA in STEMI patients at 1-year follow-up. FRAME-AMI trial showed superiority of FFR-guided PCI over angiography-guided PCI in reducing death, MI, or repeat revascularization during median 3.5 years of follow-up in patients with STEMI or NSTEMI and multivessel disease.
Although IVUS and FFR differ in underlying basic concepts, previous studies demonstrated clinical outcomes following treatment decision by IVUS and FFR was similar between the 2 groups. However, these studies mainly evaluated low-risk stable ischemic heart disease patients with intermediate stenosis, and does not reflect population with acute myocardial infarction undergoing complete revascularization. Currently, the data directly comparing the benefit of IVUS and FFR for non-IRA PCI in AMI is lacking. Considering that coronary atherosclerotic plaque in non-IRA of STEMI patients is associated with significantly higher risk of future clinical events, IVUS would have potential strength of detecting high risk plaque in non-IRA and treatment decision based on plaque characteristics. Conversely, FFR-guided treatment decision for non-IRA would detect functionally significant non-IRA stenosis and treatment decision based on functional significance would reduce unnecessary PCI, as demonstrated by previous trials.
In this regard, randomized controlled trial comparing clinical outcome following non-IRA PCI in AMI patients with multivessel disease guided by IVUS or FFR would provide valuable evidence to enhance patient's prognosis after treatment of STEMI. Therefore, FRAME-AMI 2 trial is designed to compare clinical outcomes after non-IRA PCI using either IVUS-guided or FFR-guided strategy.
- Being tested
- IVUS-guided PCI group, FFR-guided PCI group
- Keywords
- ST-segment elevation MI, Fractional flow reserve, intravascular ultrasound, Multivessel disease, Complete revascularization, Non-ST Elevation Myocardial Infarction
- Medical subject headings
- ST Elevation Myocardial Infarction, Non-ST Elevated Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVUS-guided PCI groupDiagnostic test
In IVUS-guided PCI group, the current trial evaluates clinical outcome following IVUS-guided treatment decision for revascularization of non-IRA stenosis.
FFR-guided PCI groupDiagnostic test
In FFR-guided PCI group, FFR measurement for non-IRA stenosis (>50% visual estimation) will be performed by continuous infusion of adenosine (140~180 ug/kg/min) or intracoronary nicorandil (2 mg bolus) injection. The FFR ≤0.80 will be targeted for PCI. In case of non-IRA stenosis >90%, we will judge FFR value of ≤0.80.
| Study group | Role | What they receive |
|---|---|---|
| Fractional flow reserve-guided PCI | Active comparator | FFR measurement for non-IRA stenosis (>50% visual estimation) will be performed by continuous infusion of adenosine (140~180 ug/kg/min) or intracoronary nicorandil (2 mg bolus) injection. The FFR ≤0.80 will be targeted for PCI. In case of non-IRA stenosis >90%, we will judge FFR value of ≤0.80. Receives: Diagnostic Test: FFR-guided PCI group |
| Intravascular Ultrasound-guided PCI | Experimental | In IVUS-guided PCI group, the current trial evaluates clinical outcome following IVUS-guided treatment decision for revascularization of non-IRA stenosis. According to pre-defined criteria, the decision of revascularization will be made.
Revascularization criteria in the IVUS-guided PCI group is 1) minimal lumen area (MLA) ≤ 3mm2 or 2) 3mm2 < MLA ≤4mm2 and plaque burden >70%. Receives: Diagnostic Test: IVUS-guided PCI group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-Oriented Composite Outcome
a composite of death, myocardial infarction, or repeat revascularization
Measured: 2 years after last patient enrollment
Secondary outcomes (17)
All-cause death
All-cause death
Measured: 2 years after last patient enrollment
Cardiac death
Cardiac death
Measured: 2 years after last patient enrollment
Spontaneous myocardial infarction
Spontaneous myocardial infarction, defined by Forth Universal definition of myocardial infarction
Measured: 2 years after last patient enrollment
Procedure-related myocardial infarction
Procedure-related myocardial infarction, defined by ARC II definition
Measured: 2 years after last patient enrollment
Any revascularization
Any revascularization (clinically-driven or ischemia-driven)
Measured: 2 years after last patient enrollment
Infarct-related artery revascularization
Infarct-related artery revascularization
Measured: 2 years after last patient enrollment
Non-Infarct-related artery revascularization
Non-Infarct-related artery revascularization
Measured: 2 years after last patient enrollment
Definite or probable stent thrombosis
Definite or probable stent thrombosis
Measured: 2 years after last patient enrollment
Stroke (ischemic or hemorrhagic)
Stroke (ischemic or hemorrhagic)
Measured: 2 years after last patient enrollment
Total procedural time
Total procedural time (from the end of primary PCI for IRA to the completion of non-IRA PCI including amount of staged procedure)
Measured: at least 1 week after index procedure
Total fluoroscopy time
Total fluoroscopy time (from the end of primary PCI for IRA to the completion of non-IRA PCI including amount of staged procedure)
Measured: at least 1 week after index procedure
Total amount of contrast use
Total amount of contrast use (from the end of primary PCI for IRA to the completion of non-IRA PCI including amount of staged procedure)
Measured: at least 1 week after index procedure
Incidence of contrast-induced nephropathy
Incidence of contrast-induced nephropathy, defined as an increase in serum creatinine of ≥0.5mg/dL or ≥25% from baseline within 48-72 hours after contrast agent exposure.
Measured: at least 1 week after index procedure
A composite of all-cause death or myocardial infarction
A composite of all-cause death or myocardial infarction
Measured: 2 years after last patient enrollment
A composite of cardiac death or non-procedure-related myocardial infarction
A composite of cardiac death or non-procedure-related myocardial infarction
Measured: 2 years after last patient enrollment
Angina severity by Seattle Angina Questionnaire
Angina severity by Seattle Angina Questionnaire
Measured: At 2 years from index procedure
Quality of life by EQ-5D-5L Questionnaire
Quality of life by EQ-5D-5L Questionnaire
Measured: At 2 years from index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2023
- Study start18 Sep 2023
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ST Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, multicenter, randomized controlled non-inferiority trial to compare clinical outcomes between IVUS-guided PCI versus FFR-guided PCI in patients with acute MI and multivessel disease.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Chonnam National University
- Responsible party
- Principal investigator, Joo-Yong Hahn, Samsung Medical Center
- Investigators
- Joo-Yong Hahn, MD, PhD, Principal investigator, Samsung Medical CenterYoung Joon Hong, MD, PhD, Principal investigator, Chonnam National University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05812963
- Sponsor's protocol ID
- FRAMEAMI119023
- Acronym
- FRAME-AMI2
- Status last verified
- Oct 2024
- First submitted
- 22 Feb 2023
- Last updated
- 24 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After publication of main paper, de-identified data will be shared upon reasonable requests after discussion by Executive Committee.
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Intravascular Ultrasound Versus Fractional Flow Reserve for Non-infarct Related Artery Lesions in Patients With Multivessel Disease and Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT05812963
- Acronym / sponsor ID
- FRAME-AMI2 / FRAMEAMI119023
- Keywords
- ST-segment elevation MI, Fractional flow reserve, intravascular ultrasound, Multivessel disease, Complete revascularization, Non-ST Elevation Myocardial Infarction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,400 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- Chonnam National University
- Study start
- 18 Sep 2023 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 14 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to compare clinical outcomes between intravascular ultrasound (IVUS)-guided treatment decision versus fractional flow reserve (FFR)-guided treatment decision for non-infarct related artery stenosis in patients with acute myocardial infarction (AMI) and multivessel disease.
Detailed description
The treatment of choice of acute myocardial infarction (AMI) including ST-segment elevation myocardial infarction (STEMI) and non-ST segment elevation myocardial infarction (NSTEMI) is reperfusion therapy, preferably with percutaneous coronary intervention (PCI). While need of treating the infarct related artery (IRA) is obvious, need for routine revascularization of non-infarct related artery (non-IRA) has been a topic of debate until recent years. Through a number of observational studies, randomized trials and meta-analyses, the benefits of non-IRA PCI have been continuously implied, and COMPLETE trial with 4041 patients of STEMI and multivessel coronary artery disease in 2019 demonstrated superiority of complete revascularization to culprit-only PCI in terms of cardiovascular death or MI (primary end point) and cardiovascular death, MI, or ischemia-driven revascularization (co-primary end point). As such, complete revascularization of a significant non-IRA stenosis is recommended after successful PCI for IRA in patients with AMI and multivessel disease in current clinical guidelines.
Nevertheless, it has been unclear which criteria should be used to decide non-IRA PCI. Although potential significance of non-IRA lesions can be estimated by angiography, the limitation of angiographic visual assessment or quantitative coronary angiography has been well known. Various measurements are used for incremental information in addition to angiographic assessment in guiding PCI - namely, intravascular ultrasound (IVUS) and fractional flow reserve (FFR). IVUS provides anatomical information regarding the lumen, plaque, and plaque characteristics, and can optimize stent placement minimizing stent-related problems and lead to better clinical outcomes. On the other hand, FFR provides information on amount of ischemia which the stenosis in question is causing, and also improves the quality of PCI which has been demonstrated by multiple previous trials, and current practice guidelines recommend the use of FFR to determine revascularization strategy as Class IA recommendation. Recent trials evaluated comparative prognosis between FFR-guided versus angiograph-guided PCI for non-IRA in patients with acute MI and multivessel disease. FLOWER-MI trial showed comparable clinical outcome between FFR-guided versus angiography-guided PCI for non-IRA in STEMI patients at 1-year follow-up. FRAME-AMI trial showed superiority of FFR-guided PCI over angiography-guided PCI in reducing death, MI, or repeat revascularization during median 3.5 years of follow-up in patients with STEMI or NSTEMI and multivessel disease.
Although IVUS and FFR differ in underlying basic concepts, previous studies demonstrated clinical outcomes following treatment decision by IVUS and FFR was similar between the 2 groups. However, these studies mainly evaluated low-risk stable ischemic heart disease patients with intermediate stenosis, and does not reflect population with acute myocardial infarction undergoing complete revascularization. Currently, the data directly comparing the benefit of IVUS and FFR for non-IRA PCI in AMI is lacking. Considering that coronary atherosclerotic plaque in non-IRA of STEMI patients is associated with significantly higher risk of future clinical events, IVUS would have potential strength of detecting high risk plaque in non-IRA and treatment decision based on plaque characteristics. Conversely, FFR-guided treatment decision for non-IRA would detect functionally significant non-IRA stenosis and treatment decision based on functional significance would reduce unnecessary PCI, as demonstrated by previous trials.
In this regard, randomized controlled trial comparing clinical outcome following non-IRA PCI in AMI patients with multivessel disease guided by IVUS or FFR would provide valuable evidence to enhance patient's prognosis after treatment of STEMI. Therefore, FRAME-AMI 2 trial is designed to compare clinical outcomes after non-IRA PCI using either IVUS-guided or FFR-guided strategy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, multicenter, randomized controlled non-inferiority trial to compare clinical outcomes between IVUS-guided PCI versus FFR-guided PCI in patients with acute MI and multivessel disease.
| Arm | Type | Receives |
|---|---|---|
| Fractional flow reserve-guided PCI | Active comparator | Diagnostic Test: FFR-guided PCI groupFFR measurement for non-IRA stenosis (>50% visual estimation) will be performed by continuous infusion of adenosine (140~180 ug/kg/min) or intracoronary nicorandil (2 mg bolus) injection. The FFR ≤0.80 will be targeted for PCI. In case of non-IRA stenosis >90%, we will judge FFR value of ≤0.80. |
| Intravascular Ultrasound-guided PCI | Experimental | Diagnostic Test: IVUS-guided PCI groupIn IVUS-guided PCI group, the current trial evaluates clinical outcome following IVUS-guided treatment decision for revascularization of non-IRA stenosis. According to pre-defined criteria, the decision of revascularization will be made. Revascularization criteria in the IVUS-guided PCI group is 1) minimal lumen area (MLA) ≤ 3mm2 or 2) 3mm2 < MLA ≤4mm2 and plaque burden >70%. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Subject must be at least 19 years of age
- Acute ST-segment elevation myocardial infarction (STEMI)
- STEMI: ST-segment elevation ≥0.1 mV in ≥2 contiguous leads or documented newly developed left bundle-branch block
- Acute non-ST-segment elevation myocardial infarction (NSTEMI)
- NSTEMI: NSTEMI is defined as a combination of criteria with mandated elevation of a cardiac biomarker, preferably high-sensitive cardiac troponin with at least one value above 99th percentile of the upper reference limit and at least one of the following:
Key exclusion criteria (8 listed)
- Non-IRA stenosis not amenable for PCI treatment by operators' decision
- Cardiogenic shock (Killip class IV) already at presentation or the completion of IRA PCI
- Intolerance to Aspirin, Clopidogrel, Prasugrel, Ticagrelor, Heparin, or Everolimus
- Known true anaphylaxis to contrast medium (not allergic reaction but anaphylactic shock)
- Pregnancy or breast feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IVUS-guided PCI groupIn IVUS-guided PCI group, the current trial evaluates clinical outcome following IVUS-guided treatment decision for revascularization of non-IRA stenosis. | Diagnostic test | Intravascular Ultrasound-guided PCI |
| FFR-guided PCI groupIn FFR-guided PCI group, FFR measurement for non-IRA stenosis (>50% visual estimation) will be performed by continuous infusion of adenosine (140~180 ug/kg/min) or intracoronary nicorandil (2 mg bolus) injection. The FFR ≤0.80 will be targeted for PCI. In case of non-IRA stenosis >90%, we will judge FFR value of ≤0.80. | Diagnostic test | Fractional flow reserve-guided PCI |
Primary outcome
Patient-Oriented Composite Outcome
Time frame: 2 years after last patient enrollment
a composite of death, myocardial infarction, or repeat revascularization
17 secondary outcomes
All-cause death
Time frame: 2 years after last patient enrollment
Cardiac death
Time frame: 2 years after last patient enrollment
Spontaneous myocardial infarction
Time frame: 2 years after last patient enrollment
Procedure-related myocardial infarction
Time frame: 2 years after last patient enrollment
Any revascularization
Time frame: 2 years after last patient enrollment
Infarct-related artery revascularization
Time frame: 2 years after last patient enrollment
Non-Infarct-related artery revascularization
Time frame: 2 years after last patient enrollment
Definite or probable stent thrombosis
Time frame: 2 years after last patient enrollment
Stroke (ischemic or hemorrhagic)
Time frame: 2 years after last patient enrollment
Total procedural time
Time frame: at least 1 week after index procedure
Total fluoroscopy time
Time frame: at least 1 week after index procedure
Total amount of contrast use
Time frame: at least 1 week after index procedure
Incidence of contrast-induced nephropathy
Time frame: at least 1 week after index procedure
A composite of all-cause death or myocardial infarction
Time frame: 2 years after last patient enrollment
A composite of cardiac death or non-procedure-related myocardial infarction
Time frame: 2 years after last patient enrollment
Angina severity by Seattle Angina Questionnaire
Time frame: At 2 years from index procedure
Quality of life by EQ-5D-5L Questionnaire
Time frame: At 2 years from index procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2024.
- Individual participant dataSharing planned: Yes. After publication of main paper, de-identified data will be shared upon reasonable requests after discussion by Executive Committee.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joo-Yong Hahn, MD, PhD principal investigator
Samsung Medical Center
Young Joon Hong, MD, PhD principal investigator
Chonnam National University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IVUS-guided PCI group and FFR-guided PCI group in people with ST Elevation Myocardial Infarction and Non-ST Elevation Myocardial Infarction, run by Samsung Medical Center at 2 sites 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 13 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 24 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joo Myung Lee, MD, MPH, PhD (82-2-3410-2575, drone80@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-Oriented Composite Outcome (time frame: 2 years after last patient enrollment). 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 24 Oct 2024.