Clinical trial NCT05124249: Imaging and Physiologic Evaluation of Coronary Artery Disease
Official title: Imaging and Physiologic Evaluation of Coronary Artery Disease: a Prospective Registry Study (IP-CAD)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ischemic Heart Disease
Atherosclerosis
Keywords: Percutaneous Coronary Intervention
Intravascular Imaging
Intravascular Ultrasound
Optical Coherence Tomography
Fractional flow reserve
Lead sponsor: Chonnam National University Hospital
Sponsor class: OTHER
First posted: 2021-11-17
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

Eligibility criteria: 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

Primary outcomes:
measure: MACE
timeFrame: 3-Year after the index procedure
Secondary outcomes:
measure: Rate of all-cause death
timeFrame: 3-Year after the index procedure
measure: Rate of cardiac death
timeFrame: 3-Year after the index procedure
measure: Rate of myocardial infarction
timeFrame: 3-Year after the index procedure
measure: Rate of target lesion revascularization
timeFrame: 3-Year after the index procedure
measure: Rate of target vessel revascularization
timeFrame: 3-Year after the index procedure
measure: Rate of any revascularization
timeFrame: 3-Year after the index procedure
measure: Rate of stent thrombosis
timeFrame: 3-Year after the index procedure
measure: Rate of ischemic or hemorrhagic stroke
timeFrame: 3-Year after the index procedure
measure: Rate of BARC type 2,3, or 5 bleeding
timeFrame: 3-Year after the index procedure
measure: MACCE
timeFrame: 3-Year after the index procedure
Other outcomes:
Locations:
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
Study officials:
affiliation: Chonnam National University Medical School; Chonnam National University Hospital
name: Young Joon LeeHong, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: