Imaging and Physiologic Evaluation of Coronary Artery Disease

Recruiting

• Conditions: Atherosclerosis; Ischemic Heart Disease
• Interventions: Diagnostic Test: Intravascular imaging (IVUS or OCT) or Invasive physiologic assessment; Procedure: PCI

• Registration Number: NCT05124249
• Lead Sponsor: Chonnam National University Hospital

Brief 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.

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 Timeline

• Study Start: 2021-11-01
• Study First Submitted: 2021-11-04
• Study First Submitted QC: 2021-11-15
• Study First Posted: 2021-11-17
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-21
• Last Update Posted: 2024-02-23
• Primary Completion: 2024-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

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

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Exclusion Criteria

• Subject with Age <18 years
• Pregnant women

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Invasive coronary angiography (ICA)	Intravascular imaging (IVUS or OCT) or Invasive physiologic assessment	Patients who undergoing invasive coronary angiography with intravascular imaging or invasive physiologic assessment
Percutaneous coronary intervention (PCI)	Intravascular imaging (IVUS or OCT) or Invasive physiologic assessment	Patients who undergoing percutaneous coronary intervention with intravascular imaging or invasive physiologic assessment
Percutaneous coronary intervention (PCI)	PCI	Patients who undergoing percutaneous coronary intervention with intravascular imaging or invasive physiologic assessment

Primary Outcome Measures

Name	Time	Method
MACE	3-Year after the index procedure	a composite of all-cause death, myocardial infarction, or any revascularization

Secondary Outcome Measures

Name	Time	Method
MACCE	3-Year after the index procedure	a composite of all-cause death, myocardial infarction, any revascularization, and ischemic or hemorrhagic stroke
Rate of ischemic or hemorrhagic stroke	3-Year after the index procedure	Ischemic or hemorrhagic stoke by braing imaging
Rate of target lesion revascularization	3-Year after the index procedure	ischemia-driven or all
Rate of cardiac death	3-Year after the index procedure	death from cardiac-cause
Rate of stent thrombosis	3-Year after the index procedure	definite or probable
Rate of all-cause death	3-Year after the index procedure	death from any-cause
Rate of myocardial infarction	3-Year after the index procedure	Myocardial infarction without peri-procedural myocardial infarction
Rate of target vessel revascularization	3-Year after the index procedure	ischemia-driven or all
Rate of any revascularization	3-Year after the index procedure	ischemia-driven or all
Rate of BARC type 2,3, or 5 bleeding	3-Year after the index procedure	Bleeding Academic Research Consortium (BARC) type 2,3 or 5 bleeding

Trial Locations

Locations (1)

Chonnam National University Hospital; 🇰🇷 Gwangju, Korea, Republic of