Chronic Coronary Syndrome
Conditions
Interventions
During PCI, coronary physiological assessment will be performed using continuous thermodilution with the RayFlow catheter. Absolute coronary blood flow and coronary microvascular resistance will be me
Sponsors
Institute of Science Tokyo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients aged 20 years or older. 2) Patients diagnosed with chronic coronary syndrome, including stable angina, exertional angina, or silent myocardial ischemia, who are scheduled to undergo percutaneous coronary intervention (PCI). 3) Patients who agree to undergo coronary blood flow assessment using continuous thermodilution with the RayFlow catheter during PCI. 4) Patients who are able to provide written informed consent for participation in this study.
Exclusion criteria
Exclusion criteria: 1) Patients with acute coronary syndrome, including ST-elevation myocardial infarction, non-ST-elevation myocardial infarction, or unstable angina. 2) Patients with cardiogenic shock. 3) Patients with renal dysfunction, defined as eGFR less than 30 mL/min/1.73 m2. 4) Patients with allergy to contrast media. 5) Patients with contraindications to coronary angiography or PCI. 6) Patients with a target vessel diameter less than 2.0 mm in whom safe insertion or manipulation of the RayFlow catheter is considered difficult. 7) Patients with severe left ventricular dysfunction, defined as LVEF less than 30%. 8) Patients judged by the principal investigator to be unsuitable for the study. 9) Patients who do not provide consent for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in hyperemic absolute coronary blood flow Q in mL per min and hyperemic coronary microvascular resistance Rmu in Wood units in the target vessel from immediately before to immediately after PCI | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Changes in coronary flow reserve (CFR), fractional flow reserve (FFR), and microvascular resistance reserve (MRR) in the target vessel from immediately before to immediately after PCI. 2) Inter-vessel heterogeneity of coronary microvascular resistance (Rmu) among the three major coronary arteries before PCI, including standard deviation, coefficient of variation, and max-min difference. 3) Absolute coronary blood flow, coronary microvascular resistance, and MRR in non-target vessels before PCI, and the prevalence of coronary microvascular dysfunction (CMD), defined as MRR less than 3.0. 4) Associations of changes in absolute coronary blood flow and coronary microvascular resistance with FFR, QCA findings, intracoronary imaging findings, and patient background factors. 5) Changes in patient-reported outcomes, including SAQ-7, PHQ-9, and GAD-7, from before PCI to approximately 1 month after PCI, and their associations with coronary physiological indices. | — |
Countries
Japan
Contacts
Public ContactMasahiro Hoshino
Institute of Science Tokyo Hospital Department of cardiology
Outcome results
None listed