Clinical Trials Directory

Trials / Recruiting

RecruitingNCT05124249

Imaging and Physiologic Evaluation of Coronary Artery Disease

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

Status
Recruiting
Phase
Study type
Observational
Enrollment
2,000 (estimated)
Sponsor
Chonnam National University Hospital · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTIntravascular imaging (IVUS or OCT) or Invasive physiologic assessmentIntravascular imaging (IVUS or OCT) or Invasive physiologic assessment
PROCEDUREPCIPatients who undergoing PCI

Timeline

Start date
2021-11-01
Primary completion
2029-12-31
Completion
2030-12-31
First posted
2021-11-17
Last updated
2026-03-18

Locations

1 site across 1 country: South Korea

Source: ClinicalTrials.gov record NCT05124249. Inclusion in this directory is not an endorsement.