Clinical Trial: A Prospective Observational Study Comparing Coronary Blood Flow and Microcirculation Assessment Between Photon-Counting CT and N-13 Ammonia PET (Japan)

Tokyo, Oct. 14 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059360) titled 'A Prospective Observational Study Comparing Coronary Blood Flow and Microcirculation Assessment Between Photon-Counting CT and N-13 Ammonia PET' on Oct. 14.

Study Type: Observational

Primary Sponsor: Institute - Institute of Science Tokyo

Condition: Condition - Symptomatic Stable Angina Pectoris Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The purpose of this study is to prospectively evaluate the degree of agreement between coronary flow reserve (CFR) calculated using photon-counting CT (PCCT) and those obtained by N-13 ammonia PET in patients with symptomatic stable angina pectoris. Basic objectives2 - Others

Eligibility: Age-lower limit - 18 years-old

Gender - Male and Female Key inclusion criteria - Patients clinically diagnosed with symptomatic stable angina pectoris

Aged 20 years or older and under 85 years at the time of obtaining informed consent

Physically suitable for both cardiac CT and PET examinations, and able to undergo pharmacologic stress testing (e.g., adenosine)

Provided written informed consent after receiving adequate explanation of the study Key exclusion criteria - Patients with obesity that may cause technical difficulty or significant image degradation (e.g., BMI > 35) Patients with significant arrhythmias (e.g., frequent premature beats or atrial fibrillation) that preclude stable ECG gating, as judged by the investigator Pregnant or breastfeeding women Patients with severe renal dysfunction (eGFR < 30 mL/min/1.73m2) Patients with severe hepatic dysfunction (equivalent to Child-Pugh class C) Patients with a history of severe allergy to iodinated contrast agents or pharmacologic stress agents (e.g., adenosine) Patients with clinically significant comorbidities (e.g., acute heart failure) that make participation unsafe Patients deemed inappropriate for participation by the principal investigator or sub-investigator Target Size - 50

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 10 Month 01 Day Anticipated trial start date - 2025 Year 10 Month 15 Day Last follow-up date - 2027 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067891

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