Tokyo, Aug. 25 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062588) titled 'Comparison of coronary microvascular function assessment using continuous and conventional thermodilution in patients with angina and non-obstructive coronary arteries' on Aug. 25.

Study Type: Interventional

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

Primary Sponsor: Institute - Institute of Science Tokyo

Condition: Condition - Angina with Non-Obstructive Coronary Arteries (ANOCA) Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The objective of this study is to prospectively compare coronary flow reserve and microvascular resistance measured by conventional bolus thermodilution and continuous thermodilution using the RayFlow catheter in patients with suspected angina with non-obstructive coronary arteries (ANOCA), and to assess the agreement and differences between the two methods in diagnosing microvascular angina according to the COVADIS criteria. The study will also explore associations among vasospastic endotypes identified by acetylcholine provocation testing, coronary microvascular flow-resistance phenotypes, and clinical symptoms. Basic objectives2 - Bio-equivalence

Intervention: Interventions/Control_1 - All participants will undergo coronary angiography, conventional bolus thermodilution for measurement of CFR and IMR, and acetylcholine provocation testing as standard clinical care. As an additional research procedure, after completion of acetylcholine provocation testing and intracoronary nitroglycerin administration, continuous thermodilution will be performed once in the left anterior descending coronary artery using the RayFlow catheter and a pressure and temperature sensor guidewire. Room temperature normal saline will be infused at 10 mL/min for 60 seconds and then at 20 mL/min for 60 seconds. Qrest, Qhyper, Rmicro, CFRabs, and MRR will be calculated. Where feasible, ACh-CFR and ACh-IMR will also be measured during clinically indicated acetylcholine provocation testing using the guidewire already in place, without any additional device or drug administration.

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 with angina or angina-equivalent symptoms in whom ANOCA is suspected. 3. Patients without severe stenosis on coronary angiography, or patients with intermediate stenosis in whom flow-limiting epicardial coronary disease is excluded by an FFR greater than 0.80 or a negative iFR. 4. Patients for whom acetylcholine provocation testing and invasive coronary physiological assessment are considered clinically appropriate as part of routine clinical care. 5. Patients able to provide written informed consent to participate in the study. Key exclusion criteria - 1. Acute coronary syndrome, cardiogenic shock, or hemodynamic instability. 2. Left main coronary artery disease, significant coronary stenosis with an FFR of 0.80 or less, or severe coronary stenosis for which revascularization should take priority. 3. High-grade atrioventricular block, clinically significant bradyarrhythmia, uncontrolled tachyarrhythmia, or another condition that raises safety concerns regarding acetylcholine or adenosine or ATP provocation, unless the treating physician considers the procedure safe, such as in a patient with an implanted pacemaker. 4. Severe asthma or any contraindication to adenosine or ATP administration. 5. An eGFR below 30 mL/min/1.73 m2, contrast medium allergy, current pregnancy, or possible pregnancy. 6. Severe left ventricular dysfunction, severe valvular heart disease, decompensated heart failure, or a serious comorbidity associated with a life expectancy of less than 1 year. 7. A target vessel considered too small for safe insertion of a pressure-temperature sensor wire or RayFlow catheter. 8. Any other condition considered unsuitable for study participation by the principal investigator or a subinvestigator. 9. Inability to provide written informed consent for study participation. Target Size - 100

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 08 Month 16 Day Anticipated trial start date - 2026 Year 08 Month 25 Day Last follow-up date - 2029 Year 09 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071642

Disclaimer: Curated by HT Syndication.