REASSURE-NIRS Registry
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age20-95
SponsorNational Cerebral and Cardiovascular Center, Japan
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
Study population should be patients with coronary artery disease who requires coronary angiography and/or percutaneous coronary intervention with NIRS imaging
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
near-infrared spectroscopy
DeviceNear-infrared spectroscopy is an intravascular imaging device to visualize lipid-rich plaque of coronary artery.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
MACE
major adverse cardiovascular events (=cardiac-cause death, non-fatal MI and clinically-driven non-restenotic coronary revascularization)
Time frame
at an average of 3 yearSecondary outcomes
1
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.
Time frame
Physiological measures are collected during the procedure: percutaneous coronary interventionOther outcomes
1
The occurrence of MACE in patients who achieved LDL-C <1.4 mmol/L
The efficacy of LDL-C \<1.4 mmol/L on MACE
Time frame
at an average of 2 year2
gender difference in NIRS-derived measures
sex-related difference in maxLCBI
Time frame
NIRS-derived measures are collected during the procedureSponsors and contacts
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Source ClinicalTrials.gov