Imaging and Physiologic Evaluation of Coronary Artery Disease

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.

Study Overview

• Status: Recruiting
• Conditions: Atherosclerosis; Ischemic Heart Disease
• Intervention / Treatment: Diagnostic test: Intravascular imaging (IVUS or OCT) or Invasive physiologic assessment; Procedure: PCI

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 Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

• Study Contact: Name: Seung Hun Lee, MD, PhD; Phone Number: 82-62-220-4246; Email: lsh8602@naver.com
• Study Contact Backup: Name: Young Joon Hong, MD, PhD; Phone Number: 82-62-220-5778; Email: hyj200@hanmail.net

Study Locations

• South Korea
  • Gwangju, South Korea, 61469
    • Recruiting
    • Chonnam National University Hospital
    • Principal Investigator: Young Joon Hong, MD, PhD
    • Contact: Seung Hun Lee, MD, PhD; Phone Number: 82-62-220-4246; Email: lsh8602@naver.com
    • Contact: Young Joon Hong, MD, PhD; Phone Number: 82-62-220-5778; Email: hyj200@hanmail.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

About 2,000 patients with suspected ischemic heart disease and underwent ICA, intravascular imaging, or invasive physiologic assessment

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Subject with Age <18 years
• Pregnant women

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Invasive coronary angiography (ICA); Patients who undergoing invasive coronary angiography with intravascular imaging or invasive physiologic assessment	Diagnostic test: Intravascular imaging (IVUS or OCT) or Invasive physiologic assessment; 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	Diagnostic test: Intravascular imaging (IVUS or OCT) or Invasive physiologic assessment; Intravascular imaging (IVUS or OCT) or Invasive physiologic assessment; Procedure: PCI; Patients who undergoing PCI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MACE	a composite of all-cause death, myocardial infarction, or any revascularization	3-Year after the index procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of all-cause death	death from any-cause	3-Year after the index procedure
Rate of cardiac death	death from cardiac-cause	3-Year after the index procedure
Rate of myocardial infarction	Myocardial infarction without peri-procedural myocardial infarction	3-Year after the index procedure
Rate of target lesion revascularization	ischemia-driven or all	3-Year after the index procedure
Rate of target vessel revascularization	ischemia-driven or all	3-Year after the index procedure
Rate of any revascularization	ischemia-driven or all	3-Year after the index procedure
Rate of stent thrombosis	definite or probable	3-Year after the index procedure
Rate of ischemic or hemorrhagic stroke	Ischemic or hemorrhagic stoke by braing imaging	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	3-Year after the index procedure
MACCE	a composite of all-cause death, myocardial infarction, any revascularization, and ischemic or hemorrhagic stroke	3-Year after the index procedure

Collaborators and Investigators

• Sponsor: Chonnam National University Hospital
• Investigators: Principal Investigator: Young Joon LeeHong, MD, PhD, Chonnam National University Medical School; Chonnam National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: November 4, 2021
• First Submitted That Met QC Criteria: November 15, 2021
• First Posted (Actual): November 17, 2021

Study Record Updates

• Last Update Posted (Actual): March 18, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Percutaneous Coronary Intervention; Fractional flow reserve; Optical Coherence Tomography; Intravascular Ultrasound; Intravascular Imaging
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Myocardial Ischemia; Atherosclerosis; Investigative Techniques; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Diagnostic Imaging; Tomography, Optical; Optical Imaging; Tomography, Optical Coherence
• Other Study ID Numbers: CNUH-2021-314

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: After publication of first manuscript and trial results, the de-identified data will be shared by permission of principle investigator, when asked.
• IPD Sharing Time Frame: 1 year after study completion
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No