Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Ischemic Heart Disease
Design
Observational Model: Case-ControlTime Perspective: Prospective

Participation Requirements

Age
Between 20 years and 85 years
Gender
Both males and females

Description

The current study cohort consisted with 3 cohort. In order to derive and validate the optimal cut-off values of FFR step-up amount for physiologic major vs minor stenosis and for physiologic minor stenosis vs. signal noise, the below 3 cohorts will be used. Derivation cohort of defining the optimal ...

The current study cohort consisted with 3 cohort. In order to derive and validate the optimal cut-off values of FFR step-up amount for physiologic major vs minor stenosis and for physiologic minor stenosis vs. signal noise, the below 3 cohorts will be used. Derivation cohort of defining the optimal cut off value of FFR step-up amount for physiologic major vs minor stenosis and for physiologic minor stenosis vs. signal noise. The cohort of no coronary atherosclerosis confirmed by both angiography and intravascular ultrasound will be derived from patients with heart transplantation (NCT02798731). The cohort of significant focal or diffuse obstructive coronary artery disease with functional significance defined by FFR<=0.80 will be derived from post-PCI registry of Samsung Medical Center. Internal validation cohort will be post-PCI registry of Samsung Medical Center which enrolled 236 patients who underwent both pre- and post-PCI physiologic assessment after angiographically successful PCI using 2nd generation drug-eluting stent. Among this cohort, 234 patients with available pre-PCI pullback recording will be analyzed. External validation cohort will be COE-PERSPECTIVE registry (NCT01873560) which enrolled patients who underwent PCI for lesions with FFR<=0.80 and underwent post-PCI physiologic assessment. Among the 835 patients, 252 patients with available pre-PCI pullback recording will be analyzed. For the association between physiologic major, minor, or mixed stenosis classified using the optimal cut-off values of FFR step-up amount for physiologic major vs minor stenosis and for physiologic minor stenosis vs. signal noise, the patient level pooled data of both Samsung Medical Center registry and COE-PERSPECTIVE registry will be used.

Tracking Information

NCT #
NCT04304677
Collaborators
  • Inje University
  • Keimyung University Dongsan Medical Center
  • Ulsan University Hospital
  • Sejong General Hospital
  • Seoul National University Hospital
Investigators
Not Provided