REASSURE-NIRS Registry

Study Overview
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Brief Summary
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RESSURE-NIRS registry is designed to investigate clinical and pathophysiological characteristics of NIRS-derived lipid-rich plaque in patients with coronary artery disease. This is an on-going multi-center prospective registry in Japan.

Detailed Description
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NIRS imaging is an invasive intravascular imaging modality to quantitatively visualize lipid-rich atheroma in vivo. While NIRS-derived lipid-rich plaque has been shown to associate with cardiovascular events, there is limited clinical data about the association of this high-risk plaque with risk factors, medication use, prognosis and response of PCI. RESSURE-NIRS registry is an on-going multi-center prospective registry in Japan, which enroll subjects with coronary artery disease who received NIRS imaging to evaluate coronary atherosclerosis. The primary outcome is maximum 4-mm lipid core burden index at coronary lesions measured by NIRS imaging. Secondary major outcomes include entire lipid core burden index, plaque volume, plaque attenuation and echo-lucent area. The anticipated number of study subjects is 2000 cases.

Official Title
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REvelation of PAthophySiological PhenotypeS of VUlneRable Lipid-Rich PlaquE on Near-InfraRed Spectroscopy: REASSURE-NIRS

Conditions
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Lipid-Rich Atherosclerosis of Coronary Artery

Intervention / Treatment
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* Device: near-infrared spectroscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with coronary artery disease clinical indication for coronary angiography and/or percutaneous coronary intervention visualization of coronary lesions with NIRS Exclusion Criteria: poor quality of NIRS images

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: near-infrared spectroscopy|Near-infrared spectroscopy is an intravascular imaging device to visualize lipid-rich plaque of coronary artery.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACE | major adverse cardiovascular events (=cardiac-cause death, non-fatal MI and clinically-driven non-restenotic coronary revascularization) | at an average of 2 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coronary physiological characteristics at lipid-rich plaques | Identify and quantify coronary physiological findings (=fractional flow reserve and delta fractional flow reserve) for cardiovascular risk stratification of persons with lipid-rich plaques. | Physiological measures are collected during the procedure: percutaneous coronary intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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near-infrared spectroscopy, lipid-rich plaque, coronary artery disease, intravascular imaging