Imaging and Physiologic Evaluation of Coronary Artery Disease

Chonnam National University

Status: Enrolling

Conditions: Ischemic Heart Disease; Atherosclerosis

Treatments: Diagnostic Test: Intravascular imaging (IVUS or OCT) or Invasive physiologic assessment; Procedure: PCI

Study type: Observational

Funder types: Other

Identifiers

NCT05124249

CNUH-2021-314

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

2,000 participants in 2 patient groups

Invasive coronary angiography (ICA)

Description:

Patients who undergoing invasive coronary angiography with intravascular imaging or invasive physiologic assessment

Treatment:

Diagnostic Test: Intravascular imaging (IVUS or OCT) or Invasive physiologic assessment

Percutaneous coronary intervention (PCI)

Description:

Patients who undergoing percutaneous coronary intervention with intravascular imaging or invasive physiologic assessment

Treatment:

Procedure: PCI

Diagnostic Test: Intravascular imaging (IVUS or OCT) or Invasive physiologic assessment