Imaging and Physiologic Evaluation of Coronary Artery Disease

Atherosclerosis Clinical Trial

Official title:

Imaging and Physiologic Evaluation of Coronary Artery Disease: a Prospective Registry Study (IP-CAD)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05124249
• Other study ID #: CNUH-2021-314
• Status: Recruiting
• Start date: November 1, 2021
• Est. completion date: December 31, 2027

Study information

• Verified date: February 2024
• Source: Chonnam National University Hospital
• Contact: Young Joon Hong, MD, PhD
• Phone: 82-62-220-5778
• Email: hyj200[@]hanmail.net
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerosis
• Coronary Artery Disease
• Coronary Disease
• Heart Diseases
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Chonnam National University Hospital	Gwangju

Sponsors (1)

Lead Sponsor	Collaborator
Chonnam National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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