An observational study in Coronary Artery Disease, sponsored by Sejong General Hospital. Recruiting at 1 site in Korea, Republic of. Open to participants aged 20 Years to 90 Years. Per ClinicalTrials.gov, last updated 2023-10-10.
Sponsored by Sejong General Hospital · Observational
The goal of this observational study is to evaluate diagnostic performance of resting full-cycle rate (RFR) in side branch lesion.
We aims to evaluate whether the diagnostic performance of RFR in the side branch lesion is non-inferior compared to that in the main vessel lesion RFR and FFR measurements will be performed to define functional significance in patients with side branch lesion with or without main vessel lesion
The presence of myocardial ischemia is the most important prognostic indicator in patients with coronary artery disease. Pressure-based functional assessment has been recommended to assess the presence of myocardial ischemia due to low accuracy of image-based assessment in intermediate coronary artery disease. Selective revascularization for only ischemia-producing lesion with fractinal flow reserve(FFR) guidance proved to decrease adverse cardiac events and avoid unnecessary coronary stenting, compared to angiography-guided revascularization. Therefore, Current guidelines strongly recommend FFR measurement for the assessment of the functional severity of moderate stenosis of a culprit lesion in stable coronary artery disease, and non-culprit lesion in acute coronary syndrome. However, it's clinical adaption in a real world was still very low, because of the need of pressure wire and hyperemic agent. Instantaneous flow ratio (iFR), which the ratio of distal coronary artery pressure to aortic pressure during wave-free period at rest, had a high diagnostic accuracy to define functional significance without need of adenosine. According to two large randomized trials, iFR-guided coronary revascularization proved to be non-inferior to FFR-guided revascularization with respect to one-year risk of major adverse cardiac events. Recently, new adenosine-free index, called as a resting full-cycle ratio (RFR), which is completely independent of the ECG and irrespective of systole or diastole has been validated to detect myocardial ischemia. RFR is not limited by sensitive land marking of components of the pressure waveform unlike iFR, and is diagnostically equivalent to iFR.
This novel physiologic index without need of adenosine have a potential to widely spread of functional assessment for coronary artery stenosis in daily clinical practice, and simplify procedure in complex coronary artery disease. Therefore, we sought to investigate diagnostic performance of this novel physiologic index to define myocardial ischemia in coronary bifurcation lesion, which is one of complex lesion subset.
4,857 studies on the registry are indexed under Coronary Artery Disease; 890 are open to participants now.
This study's planned enrollment of 286 is below the median of 320 across 1,687 observational studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Sejong General Hospital is the lead sponsor of 8 studies on the registry; 3 are open to participants now.
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Patients with side branch lesion, who need functional evaluation
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RFR and FFR measurements in main vessel and side branch lesions
Also known as: fractional flow ratio (FFR) measurments
diagnostic sensitivity of RFR in side branch lesions
diagnostic sensitivity of RFR to predict FFR \< 0.80
Time frame: during index coronary angiography
Specificity, positive predictability, negative predictability, diagnostic accuracy, area under the curve (AUC) value in side branch
diagnostic performances of RFR to predict FFR \< 0.80
Time frame: during index coronary angiography
Plan to share: No
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Sejong General Hospital