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NCT Number: NCT05124249

Imaging and Physiologic Evaluation of Coronary Artery Disease

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intravascular imaging (IVUS or OCT) or Invasive physiologic assessment

Diagnostic Test

Intravascular imaging (IVUS or OCT) or Invasive physiologic assessment

PCI

Procedure

Patients who undergoing PCI

Primary outcomes

  1. MACE

    Time frame: 3-Year after the index procedure

    a composite of all-cause death, myocardial infarction, or any revascularization

Secondary outcomes

  1. Rate of all-cause death

    Time frame: 3-Year after the index procedure

    death from any-cause

  2. Rate of cardiac death

    Time frame: 3-Year after the index procedure

    death from cardiac-cause

  3. Rate of myocardial infarction

    Time frame: 3-Year after the index procedure

    Myocardial infarction without peri-procedural myocardial infarction

  4. Rate of target lesion revascularization

    Time frame: 3-Year after the index procedure

    ischemia-driven or all

  5. Rate of target vessel revascularization

    Time frame: 3-Year after the index procedure

    ischemia-driven or all

  6. Rate of any revascularization

    Time frame: 3-Year after the index procedure

    ischemia-driven or all

  7. Rate of stent thrombosis

    Time frame: 3-Year after the index procedure

    definite or probable

  8. Rate of ischemic or hemorrhagic stroke

    Time frame: 3-Year after the index procedure

    Ischemic or hemorrhagic stoke by braing imaging

  9. Rate of BARC type 2,3, or 5 bleeding

    Time frame: 3-Year after the index procedure

    Bleeding Academic Research Consortium (BARC) type 2,3 or 5 bleeding

  10. MACCE

    Time frame: 3-Year after the index procedure

    a composite of all-cause death, myocardial infarction, any revascularization, and ischemic or hemorrhagic stroke

Study contacts

Contact information is provided by the study sponsor or research team.

Seung Hun Lee, MD, PhD

CONTACT

[email protected]

82-62-220-4246

Young Joon Hong, MD, PhD

CONTACT

[email protected]

82-62-220-5778

Sponsors and collaborators

Lead sponsor

Chonnam National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2029
Study completion
2030
First posted
Nov 17, 2021
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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