Ischemic Heart DiseaseNCT05124249
Imaging and Physiologic Evaluation of Coronary Artery Disease
An observational study of Ischemic Heart Disease and Atherosclerosis, run by Chonnam National University Hospital at 1 site in South Korea.
Trial summary
To evaluate the long-term clinical outcomes and prognostic factors in patients with coronary artery disease (CAD) undergoing invasive coronary angiography (ICA), intravascular imaging, or invasive physiologic assessment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Heart Disease, Atherosclerosis
- What is being tested?
- Intravascular imaging (IVUS or OCT) or Invasive physiologic assessment and PCI
- Type of treatment
- Surgery or procedure
- How many people
- 2,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Nov 2021to 31 Dec 2030
- How long will I take part?
- 3 Years
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: About 2,000 patients with suspected ischemic heart disease and underwent ICA, intravascular imaging, or invasive physiologic assessment
Who may be able to join
- Subject must be at least 18 years of age
- Subjects who suspected ischemic heart disease and underwent ICA.
- Subjects who were performed intravascular imaging or invasive physiologic assessment
Who cannot join
- Subject with Age <18 years
- Pregnant women
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
Chonnam National University Hospital
Gwangju, 61469
Young Joon Hong, MD, PhD, 82-62-220-5778, hyj200@hanmail.net
Seung Hun Lee, MD, PhD, 82-62-220-4246, lsh8602@naver.com
About this study
Official title: Imaging and Physiologic Evaluation of Coronary Artery Disease: a Prospective Registry Study (IP-CAD)
To evaluate the long-term clinical outcomes and prognostic factors in patients with coronary artery disease (CAD) undergoing invasive coronary angiography (ICA), intravascular imaging, or invasive physiologic assessment.
Read the detailed description
The traditional standard method for evaluating coronary artery disease (CAD) is invasive coronary angiography (ICA). ICA enables the assessment of anatomic severity of the epicardial artery and the severity of diameter stenosis can be closely associated with myocardial ischemia. However, there remains concern that anatomical severity is not always identical with functional significance. Actually, even the patients showed positive non-invasive tests including treadmill test, stress echocardiography, coronary computed tomography angiography, or nuclear imaging, less than half of the patients showed significant stenosis on ICA. Therefore, the investigators need further investigation to overcome the limitations of ICA.
In this regard, intravascular imaging, such as intravascular ultrasound (IVUS) and optical coherence tomography (OCT), is a useful tool for assessing the anatomical severity in more detail. Those imaging modalities produce cross-sectional images of CAD and imaging modalities are allowing to assess lesion characteristics, plaque morphology, treatment planning, and optimization of the implanted stent. Furthermore, imaging-guided percutaneous coronary intervention (PCI) has been shown favorable outcomes, compared with angiography only-guided PCI, especially in complex lesions. Meanwhile, there has been an ample body of evidence that invasive coronary physiology assessment, such as fractional flow reserve (FFR), also can be useful for assessing the functional significance. Therefore, the current guidelines have continuously recommended intracoronary imaging and invasive physiologic assessment for guiding the treatment of CAD.
The aim of the IP-CAD (Imaging and Physiologic Evaluation of Coronary Artery Disease: a Prospective Registry Study) is to evaluate the long-term clinical outcomes according to the imaging-guided or physiology-guided PCI in real-world practice.
- Conditions
- Ischemic Heart Disease, Atherosclerosis
- Being tested
- Intravascular imaging (IVUS or OCT) or Invasive physiologic assessment, PCI
- Keywords
- Percutaneous Coronary Intervention, Intravascular Imaging, Intravascular Ultrasound, Optical Coherence Tomography, Fractional flow reserve
- Medical subject headings
- Myocardial Ischemia, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravascular imaging (IVUS or OCT) or Invasive physiologic assessmentDiagnostic test
Intravascular imaging (IVUS or OCT) or Invasive physiologic assessment
PCIProcedure or surgery
Patients who undergoing PCI
| Study group | Role | What they receive |
|---|---|---|
| Invasive coronary angiography (ICA) | Patients who undergoing invasive coronary angiography with intravascular imaging or invasive physiologic assessment Receives: Diagnostic Test: Intravascular imaging (IVUS or OCT) or Invasive physiologic assessment | |
| Percutaneous coronary intervention (PCI) | Patients who undergoing percutaneous coronary intervention with intravascular imaging or invasive physiologic assessment Receives: Diagnostic Test: Intravascular imaging (IVUS or OCT) or Invasive physiologic assessment; Procedure: PCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
MACE
a composite of all-cause death, myocardial infarction, or any revascularization
Measured: 3-Year after the index procedure
Secondary outcomes (10)
Rate of all-cause death
death from any-cause
Measured: 3-Year after the index procedure
Rate of cardiac death
death from cardiac-cause
Measured: 3-Year after the index procedure
Rate of myocardial infarction
Myocardial infarction without peri-procedural myocardial infarction
Measured: 3-Year after the index procedure
Rate of target lesion revascularization
ischemia-driven or all
Measured: 3-Year after the index procedure
Rate of target vessel revascularization
ischemia-driven or all
Measured: 3-Year after the index procedure
Rate of any revascularization
ischemia-driven or all
Measured: 3-Year after the index procedure
Rate of stent thrombosis
definite or probable
Measured: 3-Year after the index procedure
Rate of ischemic or hemorrhagic stroke
Ischemic or hemorrhagic stoke by braing imaging
Measured: 3-Year after the index procedure
Rate of BARC type 2,3, or 5 bleeding
Bleeding Academic Research Consortium (BARC) type 2,3 or 5 bleeding
Measured: 3-Year after the index procedure
MACCE
a composite of all-cause death, myocardial infarction, any revascularization, and ischemic or hemorrhagic stroke
Measured: 3-Year after the index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2021
- Study start1 Nov 2021
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Chonnam National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Young Joon Hong, Chonnam National University Hospital
- Investigators
- Young Joon LeeHong, MD, PhD, Principal investigator, Chonnam National University Medical School; Chonnam National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05124249
- Sponsor's protocol ID
- CNUH-2021-314
- Status last verified
- Mar 2026
- First submitted
- 4 Nov 2021
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After publication of first manuscript and trial results, the de-identified data will be shared by permission of principle investigator, when asked.
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging and Physiologic Evaluation of Coronary Artery Disease: a Prospective Registry Study (IP-CAD)
- ClinicalTrials.gov ID
- NCT05124249
- Acronym / sponsor ID
- CNUH-2021-314
- Conditions
- Ischemic Heart Disease, Atherosclerosis
- Keywords
- Percutaneous Coronary Intervention, Intravascular Imaging, Intravascular Ultrasound, Optical Coherence Tomography, Fractional flow reserve
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Chonnam National University HospitalUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 17 Nov 2021 (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 evaluate the long-term clinical outcomes and prognostic factors in patients with coronary artery disease (CAD) undergoing invasive coronary angiography (ICA), intravascular imaging, or invasive physiologic assessment.
Detailed description
The traditional standard method for evaluating coronary artery disease (CAD) is invasive coronary angiography (ICA). ICA enables the assessment of anatomic severity of the epicardial artery and the severity of diameter stenosis can be closely associated with myocardial ischemia. However, there remains concern that anatomical severity is not always identical with functional significance. Actually, even the patients showed positive non-invasive tests including treadmill test, stress echocardiography, coronary computed tomography angiography, or nuclear imaging, less than half of the patients showed significant stenosis on ICA. Therefore, the investigators need further investigation to overcome the limitations of ICA.
In this regard, intravascular imaging, such as intravascular ultrasound (IVUS) and optical coherence tomography (OCT), is a useful tool for assessing the anatomical severity in more detail. Those imaging modalities produce cross-sectional images of CAD and imaging modalities are allowing to assess lesion characteristics, plaque morphology, treatment planning, and optimization of the implanted stent. Furthermore, imaging-guided percutaneous coronary intervention (PCI) has been shown favorable outcomes, compared with angiography only-guided PCI, especially in complex lesions. Meanwhile, there has been an ample body of evidence that invasive coronary physiology assessment, such as fractional flow reserve (FFR), also can be useful for assessing the functional significance. Therefore, the current guidelines have continuously recommended intracoronary imaging and invasive physiologic assessment for guiding the treatment of CAD.
The aim of the IP-CAD (Imaging and Physiologic Evaluation of Coronary Artery Disease: a Prospective Registry Study) is to evaluate the long-term clinical outcomes according to the imaging-guided or physiology-guided PCI in real-world practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Invasive coronary angiography (ICA) | – | Diagnostic Test: Intravascular imaging (IVUS or OCT) or Invasive physiologic assessmentPatients who undergoing invasive coronary angiography with intravascular imaging or invasive physiologic assessment |
| Percutaneous coronary intervention (PCI) | – | Diagnostic Test: Intravascular imaging (IVUS or OCT) or Invasive physiologic assessment, Procedure: PCIPatients who undergoing percutaneous coronary intervention with intravascular imaging or invasive physiologic assessment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- About 2,000 patients with suspected ischemic heart disease and underwent ICA, intravascular imaging, or invasive physiologic assessment
Key inclusion criteria (3 listed)
- Subject must be at least 18 years of age
- Subjects who suspected ischemic heart disease and underwent ICA.
- Subjects who were performed intravascular imaging or invasive physiologic assessment
Key exclusion criteria (2 listed)
- Subject with Age <18 years
- Pregnant women
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 |
|---|---|---|
| Intravascular imaging (IVUS or OCT) or Invasive physiologic assessmentIntravascular imaging (IVUS or OCT) or Invasive physiologic assessment | Diagnostic test | Invasive coronary angiography (ICA), Percutaneous coronary intervention (PCI) |
| PCIPatients who undergoing PCI | Procedure or surgery | Percutaneous coronary intervention (PCI) |
Primary outcome
MACE
Time frame: 3-Year after the index procedure
a composite of all-cause death, myocardial infarction, or any revascularization
10 secondary outcomes
Rate of all-cause death
Time frame: 3-Year after the index procedure
Rate of cardiac death
Time frame: 3-Year after the index procedure
Rate of myocardial infarction
Time frame: 3-Year after the index procedure
Rate of target lesion revascularization
Time frame: 3-Year after the index procedure
Rate of target vessel revascularization
Time frame: 3-Year after the index procedure
Rate of any revascularization
Time frame: 3-Year after the index procedure
Rate of stent thrombosis
Time frame: 3-Year after the index procedure
Rate of ischemic or hemorrhagic stroke
Time frame: 3-Year after the index procedure
Rate of BARC type 2,3, or 5 bleeding
Time frame: 3-Year after the index procedure
MACCE
Time frame: 3-Year after the 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 18 Mar 2026.
- Individual participant dataSharing planned: Yes. After publication of first manuscript and trial results, the de-identified data will be shared by permission of principle investigator, when asked.
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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.
Young Joon LeeHong, MD, PhD principal investigator
Chonnam National University Medical School; Chonnam National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Heart Disease and Atherosclerosis, run by Chonnam 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 3 inclusion and 2 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 18 Mar 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 Young Joon Hong, MD, PhD (82-62-220-5778, hyj200@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MACE (time frame: 3-Year after the index procedure). 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 18 Mar 2026.