Clinical Trial: A Prospective, Single-Center, Single-Arm Interventional Study Evaluating Changes in Absolute Coronary Blood Flow and Coronary Microvascular Resistance Before and After Percutaneous Coronary Intervention Using Continuous Thermodilution in Patients with Chronic Coronary Syndrome (Japan)

Tokyo, June 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061531) titled 'A study of coronary blood flow and small-vessel function before and after catheter-based coronary treatment in patients with chronic coronary syndrome' on June 15.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Institute of Science Tokyo

Condition: Condition - Chronic Coronary Syndrome Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To evaluate changes in absolute coronary blood flow and coronary microvascular resistance in the target vessel before and after percutaneous coronary intervention using continuous thermodilution in patients with chronic coronary syndrome scheduled to undergo PCI. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - 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 measured in the target vessel immediately before PCI. When feasible in terms of procedure time, contrast volume, and hemodynamic stability, measurements will also be performed in the three major coronary arteries including non-target vessels before PCI. After PCI, only the target vessel will be measured again. The intervention will be performed once in the catheterization laboratory on the day of PCI. The additional procedure time is approximately 10 minutes when only the target vessel is measured before and after PCI, and approximately 20 minutes when three-vessel measurements before PCI and target-vessel measurement after PCI are performed. For each vessel, room-temperature saline will be infused at 10 mL/min for 60 seconds for resting measurement, followed by infusion at 20 mL/min for 60 seconds for hyperemic measurement.

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key 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. Key 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. Target Size - 100

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 06 Month 15 Day Anticipated trial start date - 2026 Year 06 Month 15 Day Last follow-up date - 2030 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070408

Disclaimer: Curated by HT Syndication.