Imaging and Physiologic Evaluation of Coronary Artery Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intravascular imaging (IVUS or OCT) or Invasive physiologic assessment, PCI.
- Who it may be relevant to
- Registry conditions: Ischemic Heart Disease, Atherosclerosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Imaging and Physiologic Evaluation of Coronary Artery Disease: a Prospective Registry Study (IP-CAD)
Overview
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.
Interventions
- 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
Primary outcome measures
- MACE [Time frame: 3-Year after the index procedure]
Secondary outcome measures (10)
- Rate of all-cause death [Time frame: 3-Year after the index procedure]
- Rate of cardiac death [Time frame: 3-Year after the index procedure]
- Rate of myocardial infarction [Time frame: 3-Year after the index procedure]
- Rate of target lesion revascularization [Time frame: 3-Year after the index procedure]
- Rate of target vessel revascularization [Time frame: 3-Year after the index procedure]
- Rate of any revascularization [Time frame: 3-Year after the index procedure]
- Rate of stent thrombosis [Time frame: 3-Year after the index procedure]
- Rate of ischemic or hemorrhagic stroke [Time frame: 3-Year after the index procedure]
- Rate of BARC type 2,3, or 5 bleeding [Time frame: 3-Year after the index procedure]
- MACCE [Time frame: 3-Year after the index procedure]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
South Korea · 1 center
- Chonnam National University Hospital — Gwangju
Identifiers
NCT: NCT05124249 · CNUH-2021-314