Tokyo, Oct. 14 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059382) titled 'Automatic vs Manual Bolus Injection for Thermodilution Assessing Coronary Microvascular Disease' on Oct. 14.
Study Type:
Observational
Primary Sponsor:
Institute - Department of Cardiology, Sapporo Higashi Tokushukai Hospital
Condition:
Condition - Angina with nonobstructive coronary arteries
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To compare the reproducibility of manual saline injection thermodilution and automatic thermodilution using the Arcatena injection system in patients suspected of angina with nonobstructive coronary arteries (ANOCA).
Basic objectives2 - Others
Eligibility:
Age-lower limit - 20
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1) Patients with symptoms suggestive of angina.
2) Patients without epicardial coronary artery stenosis greater than 50%.
3) Patients suspected of having ANOCA based on criteria 1) and 2), who are scheduled to undergo invasive coronary physiological assessment.
4) Patients aged 20 years or older at the time of consent, regardless of sex.
5) Patients (or legally authorized representatives) who have received a full explanation of the study and have provided written informed consent of their own free will.
Key exclusion criteria - 1) Patients with decompensated heart failure.
2) Patients with a history of coronary artery bypass grafting (CABG).
3) Patients with significant valvular heart disease requiring surgical or percutaneous intervention.
4) Patients with coronary anatomy in which guidewire passage is expected to be difficult due to severe tortuosity or other anatomical reasons.
Target Size - 40
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2025 Year 06 Month 11 Day
Date of IRB - 2025 Year 06 Month 11 Day
Anticipated trial start date - 2025 Year 06 Month 11 Day
Last follow-up date - 2026 Year 05 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067918
Disclaimer: Curated by HT Syndication.