Ischemic CardiomyopathyIMPROVE-ICMPNCT06930092
RestoratIon of Myocardial Function by PeRcutaneous cOronary interVEntion in Patients With Ischemic CardioMyoPathy
A study testing Physiology-and imaging-guided PCI and Optimal medical treatment in people with Ischemic Cardiomyopathy, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
To compare the effects of physiology- and imaging-guided PCI combined with optimal medical therapy (OMT) versus OMT alone on the recovery of left ventricular systolic function in patients with ischemic cardiomyopathy and multivessel coronary artery disease. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Ischemic Cardiomyopathy
- What is being tested?
- Physiology-and imaging-guided PCI and Optimal medical treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 Aug 2025to 30 Apr 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 ≥ 19 years
- Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving invasive physiologic or imaging evaluation and PCI and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.
- Subject with LV ejection fraction <40% from cardiac MRI
- Subject with multivessel disease in major epicardial coronary artery disease or their major branches (vessel size of 2.5 mm or more than 2.5mm) considering coronary revascularization
Who cannot join
- Subjects with more than 50% transmural extent of infarction on GE-MRI in more than 25% of the dysfunctional myocardial segments
- Subject with suspicious of other cardiomyopathy (dilated cardiomyopathy, hypertrophic cardiomyopathy etc.)
- Subject with recent myocardial infarction within 4 weeks
- Subject with recent fatal arrhythmia (VT or VF) within 4 weeks
- Subject with hemodynamically unstable state
- Subject with complex coronary artery lesions, such as chronic total occlusions, in which complete revascularization is considered unfeasible
Show all 11Show fewer
- Subject for whom coronary artery bypass surgery is prioritized over coronary artery intervention
- Subject with severe valvular heart disease requiring open heart surgery
- Subject with history of coronary artery bypass surgery or valve surgery
- Subject with expected life expectancy of less than 1 year
- Subject considered ineligible for this study based on the investigator's discretion
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, Chongno-gu, 03080
Doyeon Hwang, MD, 01074462779, cardiol.intv@gmail.com
Junpil Yun, MD, 82-10-8001-9969, junpilyun@gmail.com
About this study
To compare the effects of physiology- and imaging-guided PCI combined with optimal medical therapy (OMT) versus OMT alone on the recovery of left ventricular systolic function in patients with ischemic cardiomyopathy and multivessel coronary artery disease.
Read the detailed description
This study is a prospective, open-label, randomized, multicenter trial to test the safety and efficacy of physiology- and imaging-guided complete revascularization with PCI combined with optimal medical therapy (OMT) versus OMT alone on the recovery of left ventricle ejection fraction (LVEF) in patients with ischemic cardiomyopathy and multivessel coronary artery disease.
The primary hypothesis is that physiology- and imaging-guided complete revascularization with PCI combined with OMT will show greater improvements in LV systolic function at 6 months after randomization compared with OMT alone.
Patients with left ventricular ejection fraction (LVEF) less than 40% on echocardiography will undergo gadolinium-enhanced cardiac MRI to determine the underlying cause of cardiac dysfunction and assess the presence of viable myocardium. Among patients suspected of having ischemic cardiomyopathy, those who provide informed consent will be considered for enrollment. Eligible patients undergoing invasive coronary angiography and meeting inclusion and exclusion criteria will be randomly assigned to either: a group receiving physiology- and imaging-guided PCI in combination with optimal medical therapy, or a group receiving optimal medical therapy alone.
Improvement in LVEF will be evaluated using follow-up gadolinium-enhanced cardiac MRI at 6 months. Clinical outcomes will be assessed at 6 and 12 months, and long-term outcomes will be analyzed through 36-month follow-up.
- Conditions
- Ischemic Cardiomyopathy
- Being tested
- Physiology-and imaging-guided PCI, Optimal medical treatment
- Keywords
- percutaneous coronary intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiology-and imaging-guided PCIProcedure or surgery
The criteria for performing revascularization are as follows
- Lesions with ≥50% diameter stenosis and FFR ≤ 0.80, or lesions with severe stenosis (>90%)
- In vessels meeting the above criteria, IVUS findings consistent with either:
- Minimum lumen area (MLA) ≤ 3 mm²
- 3 mm² < MLA ≤ 4 mm² and plaque burden >70%
For all target vessels and lesions identified for intervention, optimal revascularization should be pursued. The criteria for optimal revascularization are as follows, and operators are encouraged to achieve them:
- Post-PCI FFR > 0.86 in all treated vessels is recommended, with a minimum threshold of post-PCI FFR > 0.80 to achieve functional complete revascularization.
- Post-PCI ΔFFR (defined as [FFR at stent distal edge] - [FFR at stent proximal edge]) < 0.05 is recommended.
- On IVUS, achieving a minimum stent area (MSA) > 5.5 mm² and MSA/average reference lumen > 80% is recommended.
Optimal medical treatmentDrug
All study participants will receive guideline-directed medical therapy. Even for patients assigned to the optimal medical therapy group, revascularization may be performed during follow-up if clinically indicated. If such a decision is made prior to the primary endpoint assessment, a gadolinium-enhanced cardiac MRI will be performed at the time of consideration to reassess myocardial viability.
| Study group | Role | What they receive |
|---|---|---|
| Physiology-and imaging-guided PCI | Experimental | The goal is to achieve functional complete revascularization of major coronary arteries and their branches with diameters ≥2.5 mm. For lesions with ≥50% diameter stenosis, fractional flow reserve (FFR) measurement is mandatory. However, for severely stenotic lesions (>90%), revascularization may proceed at the operator's discretion without FFR assessment. In addition, intravascular ultrasound (IVUS) should be utilized during revascularization procedures and serve as an additional criterion for decision-making.
All patients in the intervention group will receive optimal medical therapy identical to that provided to the optimal medical therapy group following PCI. Receives: Procedure: Physiology-and imaging-guided PCI |
| Optimal medical treatment | Active comparator | All study participants will receive guideline-directed medical therapy, including an angiotensin receptor-neprilysin inhibitor (ARNi) or an angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB), a beta-blocker (carvedilol or bisoprolol), an aldosterone antagonist, and an SGLT2 inhibitor (empagliflozin or dapagliflozin). Medications will be administered even at low doses, as tolerated based on the patient's clinical status. Antiplatelet agents and statins will be maintained throughout the study period, and ezetimibe or PCSK9 inhibitors may be added as needed.
In addition, appropriate treatment will be provided for major cardiovascular risk factors such as hypertension, diabetes, and hyperlipidemia. Coexisting arrhythmias will be managed according to their respective guidelines. In the case of atrial fibrillation, active rate and rhythm control strategies will be implemented. Receives: Drug: Optimal medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
LV ejection fraction from GE-MRI
LV ejection fraction from gadolinium-enhanced MRI
Measured: At 6 months after randomization
Secondary outcomes (13)
Changes in the transmural extent of myocardial infarction from GE-MRI
Changes in the transmural extent of myocardial infarction from GE-MRI
Measured: At 6 months after randomization
Number of improved dysfunctional myocardial segments from GE-MRI
Number of improved dysfunctional myocardial segments from GE-MRI
Measured: At 6 months after randomization
Changes in the LV chamber size from GE MRI
Changes in the LV chamber size from GE MRI
Measured: At 6 months after randomization
LV ejection fraction from echocardiography
LV ejection fraction from echocardiography
Measured: At 6 months and 12 months after randomization
Number of improved dysfunctional myocardial segments from echocardiography
Number of improved dysfunctional myocardial segments from echocardiography
Measured: At 6 months and 12 months after randomization
Changes in the LV chamber size change from echocardiography
Changes in the LV chamber size change from echocardiography
Measured: At 6 months and 12 months after randomization
All-cause death
death from any cause
Measured: At 6 months, 12 months, and 36 months after randomization
Cardiovascular death
death from cardiovascular cause
Measured: At 6 months, 12 months, and 36 months after randomization
Non-fatal myocardial infarction
Non-fatal myocardial infarction
Measured: At 6 months, 12 months, and 36 months after randomization
Unplanned revascularization
Unplanned revascularization
Measured: At 6 months, 12 months, and 36 months after randomization
Hospitalization for heart failure
Hospitalization for heart failure
Measured: At 6 months, 12 months, and 36 months after randomization
EuroQol 5-Dimension 5-Level Questionnaire
EuroQol 5-Dimension 5-Level Questionnaire
Measured: At 6 months, 12 months, and 36 months after randomization
Brain natriuretic peptide (BNP or NT-Pro BNP) level
Brain natriuretic peptide (BNP or NT-Pro BNP) level
Measured: At 6 months, 12 months, and 36 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2025
- Study start3 Aug 2025
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic CardiomyopathyStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Masking
- None (open label)
- Enrolment
- 158 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Seoul National University Bundang Hospital, Seoul National University Boramae Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06930092
- Sponsor's protocol ID
- H-2411-106-1590
- Other IDs
- Not yet assigned, Not yet assigned
- Acronym
- IMPROVE-ICMP
- Status last verified
- Apr 2026
- First submitted
- 8 Apr 2025
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The deidentified data will be shared after publication of first manuscript
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RestoratIon of Myocardial Function by PeRcutaneous cOronary interVEntion in Patients With Ischemic CardioMyoPathy
- ClinicalTrials.gov ID
- NCT06930092
- Acronym / sponsor ID
- IMPROVE-ICMP / H-2411-106-1590
- Conditions
- Ischemic Cardiomyopathy
- Keywords
- percutaneous coronary intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 158 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Seoul National University Bundang Hospital, Seoul National University Boramae Hospital
- Study start
- 3 Aug 2025 (actual)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Apr 2029 (estimated)
- First posted
- 16 Apr 2025 (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.
To compare the effects of physiology- and imaging-guided PCI combined with optimal medical therapy (OMT) versus OMT alone on the recovery of left ventricular systolic function in patients with ischemic cardiomyopathy and multivessel coronary artery disease.
Detailed description
This study is a prospective, open-label, randomized, multicenter trial to test the safety and efficacy of physiology- and imaging-guided complete revascularization with PCI combined with optimal medical therapy (OMT) versus OMT alone on the recovery of left ventricle ejection fraction (LVEF) in patients with ischemic cardiomyopathy and multivessel coronary artery disease.
The primary hypothesis is that physiology- and imaging-guided complete revascularization with PCI combined with OMT will show greater improvements in LV systolic function at 6 months after randomization compared with OMT alone.
Patients with left ventricular ejection fraction (LVEF) less than 40% on echocardiography will undergo gadolinium-enhanced cardiac MRI to determine the underlying cause of cardiac dysfunction and assess the presence of viable myocardium. Among patients suspected of having ischemic cardiomyopathy, those who provide informed consent will be considered for enrollment. Eligible patients undergoing invasive coronary angiography and meeting inclusion and exclusion criteria will be randomly assigned to either: a group receiving physiology- and imaging-guided PCI in combination with optimal medical therapy, or a group receiving optimal medical therapy alone.
Improvement in LVEF will be evaluated using follow-up gadolinium-enhanced cardiac MRI at 6 months. Clinical outcomes will be assessed at 6 and 12 months, and long-term outcomes will be analyzed through 36-month follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physiology-and imaging-guided PCI | Experimental | Procedure: Physiology-and imaging-guided PCIThe goal is to achieve functional complete revascularization of major coronary arteries and their branches with diameters ≥2.5 mm. For lesions with ≥50% diameter stenosis, fractional flow reserve (FFR) measurement is mandatory. However, for severely stenotic lesions (>90%), revascularization may proceed at the operator's discretion without FFR assessment. In addition, intravascular ultrasound (IVUS) should be utilized during revascularization procedures and serve as an additional criterion for decision-making. All patients in the intervention group will receive optimal medical therapy identical to that provided to the optimal medical therapy group following PCI. |
| Optimal medical treatment | Active comparator | Drug: Optimal medical treatmentAll study participants will receive guideline-directed medical therapy, including an angiotensin receptor-neprilysin inhibitor (ARNi) or an angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB), a beta-blocker (carvedilol or bisoprolol), an aldosterone antagonist, and an SGLT2 inhibitor (empagliflozin or dapagliflozin). Medications will be administered even at low doses, as tolerated based on the patient's clinical status. Antiplatelet agents and statins will be maintained throughout the study period, and ezetimibe or PCSK9 inhibitors may be added as needed. In addition, appropriate treatment will be provided for major cardiovascular risk factors such as hypertension, diabetes, and hyperlipidemia. Coexisting arrhythmias will be managed according to their respective guidelines. In the case of atrial fibrillation, active rate and rhythm control strategies will be implemented. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject must be ≥ 19 years
- Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving invasive physiologic or imaging evaluation and PCI and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.
- Subject with LV ejection fraction <40% from cardiac MRI
- Subject with multivessel disease in major epicardial coronary artery disease or their major branches (vessel size of 2.5 mm or more than 2.5mm) considering coronary revascularization
Key exclusion criteria (11 listed)
- Subjects with more than 50% transmural extent of infarction on GE-MRI in more than 25% of the dysfunctional myocardial segments
- Subject with suspicious of other cardiomyopathy (dilated cardiomyopathy, hypertrophic cardiomyopathy etc.)
- Subject with recent myocardial infarction within 4 weeks
- Subject with recent fatal arrhythmia (VT or VF) within 4 weeks
- Subject with hemodynamically unstable state
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 |
|---|---|---|
| Physiology-and imaging-guided PCIThe criteria for performing revascularization are as follows 1. Lesions with ≥50% diameter stenosis and FFR ≤ 0.80, or lesions with severe stenosis (>90%) 2. In vessels meeting the above criteria, IVUS findings consistent with either: * Minimum lumen area (MLA) ≤ 3 mm² * 3 mm² < MLA ≤ 4 mm² and plaque burden >70% For all target vessels and lesions identified for intervention, optimal revascularization should be pursued. The criteria for optimal revascularization are as follows, and operators are encouraged to achieve them: 1. Post-PCI FFR > 0.86 in all treated vessels is recommended, with a minimum threshold of post-PCI FFR > 0.80 to achieve functional complete revascularization. 2. Post-PCI ΔFFR (defined as [FFR at stent distal edge] - [FFR at stent proximal edge]) < 0.05 is recommended. 3. On IVUS, achieving a minimum stent area (MSA) > 5.5 mm² and MSA/average reference lumen > 80% is recommended. | Procedure or surgery | Physiology-and imaging-guided PCI |
| Optimal medical treatmentAll study participants will receive guideline-directed medical therapy. Even for patients assigned to the optimal medical therapy group, revascularization may be performed during follow-up if clinically indicated. If such a decision is made prior to the primary endpoint assessment, a gadolinium-enhanced cardiac MRI will be performed at the time of consideration to reassess myocardial viability. | Drug | Optimal medical treatment |
Primary outcome
LV ejection fraction from GE-MRI
Time frame: At 6 months after randomization
LV ejection fraction from gadolinium-enhanced MRI
13 secondary outcomes
Changes in the transmural extent of myocardial infarction from GE-MRI
Time frame: At 6 months after randomization
Number of improved dysfunctional myocardial segments from GE-MRI
Time frame: At 6 months after randomization
Changes in the LV chamber size from GE MRI
Time frame: At 6 months after randomization
LV ejection fraction from echocardiography
Time frame: At 6 months and 12 months after randomization
Number of improved dysfunctional myocardial segments from echocardiography
Time frame: At 6 months and 12 months after randomization
Changes in the LV chamber size change from echocardiography
Time frame: At 6 months and 12 months after randomization
All-cause death
Time frame: At 6 months, 12 months, and 36 months after randomization
Cardiovascular death
Time frame: At 6 months, 12 months, and 36 months after randomization
Non-fatal myocardial infarction
Time frame: At 6 months, 12 months, and 36 months after randomization
Unplanned revascularization
Time frame: At 6 months, 12 months, and 36 months after randomization
Hospitalization for heart failure
Time frame: At 6 months, 12 months, and 36 months after randomization
EuroQol 5-Dimension 5-Level Questionnaire
Time frame: At 6 months, 12 months, and 36 months after randomization
Brain natriuretic peptide (BNP or NT-Pro BNP) level
Time frame: At 6 months, 12 months, and 36 months after randomization
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 Apr 2026.
- Individual participant dataSharing planned: Yes. The deidentified data will be shared after publication of first manuscript
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiology-and imaging-guided PCI and Optimal medical treatment in people with Ischemic Cardiomyopathy, run by Seoul National University Hospital at 1 site 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 4 inclusion and 11 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 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Doyeon Hwang, MD (82-10-7446-2779, cardiol.intv@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LV ejection fraction from GE-MRI (time frame: At 6 months after randomization). 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 Apr 2026.