Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Invasive coronary angiography (ICA) | Patients who undergoing invasive coronary angiography with intravascular imaging or invasive physiologic assessment |
| |
| Percutaneous coronary intervention (PCI) | Patients who undergoing percutaneous coronary intervention with intravascular imaging or invasive physiologic assessment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravascular imaging (IVUS or OCT) or Invasive physiologic assessment | Diagnostic Test | Intravascular imaging (IVUS or OCT) or Invasive physiologic assessment |
|
| Measure | Description | Time Frame |
|---|---|---|
| MACE | a composite of all-cause death, myocardial infarction, or any revascularization | 3-Year after the index procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of all-cause death | death from any-cause | 3-Year after the index procedure |
| Rate of cardiac death | death from cardiac-cause | 3-Year after the index procedure |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
About 2,000 patients with suspected ischemic heart disease and underwent ICA, intravascular imaging, or invasive physiologic assessment
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Young Joon Hong, MD, PhD | Contact | 82-62-220-5778 | hyj200@hanmail.net | |
| Seung Hun Lee, MD, PhD | Contact | 82-62-220-4246 | lsh8602@naver.com |
| Name | Affiliation | Role |
|---|---|---|
| Young Joon LeeHong, MD, PhD | Chonnam National University Medical School; Chonnam National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chonnam National University Hospital | Recruiting | Gwangju | 61469 | South Korea |
After publication of first manuscript and trial results, the de-identified data will be shared by permission of principle investigator, when asked.
1 year after study completion
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 4, 2021 | Nov 15, 2021 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D050197 | Atherosclerosis |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D001161 | Arteriosclerosis |
Not provided
Not provided
| ID | Term |
|---|---|
| D041623 | Tomography, Optical Coherence |
| ID | Term |
|---|---|
| D041622 | Tomography, Optical |
| D061848 | Optical Imaging |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
Not provided
Not provided
Not provided
Not provided
Not provided
| PCI | Procedure | Patients who undergoing PCI |
|
| Rate of myocardial infarction | Myocardial infarction without peri-procedural myocardial infarction | 3-Year after the index procedure |
| Rate of target lesion revascularization | ischemia-driven or all | 3-Year after the index procedure |
| Rate of target vessel revascularization | ischemia-driven or all | 3-Year after the index procedure |
| Rate of any revascularization | ischemia-driven or all | 3-Year after the index procedure |
| Rate of stent thrombosis | definite or probable | 3-Year after the index procedure |
| Rate of ischemic or hemorrhagic stroke | Ischemic or hemorrhagic stoke by braing imaging | 3-Year after the index procedure |
| 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 |
| MACCE | a composite of all-cause death, myocardial infarction, any revascularization, and ischemic or hemorrhagic stroke | 3-Year after the index procedure |
| D001157 |
| Arterial Occlusive Diseases |
| D003933 | Diagnosis |
| D014054 | Tomography |
| D008919 | Investigative Techniques |