Tokyo, Aug. 2 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058653) titled 'Validation of Free-Breathing Cardiac Cine: A single-center prospective study' on July 31.
Study Type:
Observational
Primary Sponsor:
Institute - Tohoku University
Condition:
Condition - Patients requiring cardiac MRI due to ischemic heart disease, cardiomyopathy, valvular heart disease, congenital heart disease, etc.
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The objective of this prospective observational study is to assess the clinical validity of a novel free-breathing cardiac cine MRI technique by comparing left ventricular ejection fraction (LVEF) measurements obtained with the conventional breath-hold cine against those acquired with the free-breathing cine in patients clinically indicated for cardiac MRI at Tohoku University Hospital. The primary endpoint is the difference in LVEF between the two methods.
Basic objectives2 - Efficacy
Eligibility:
Age-lower limit - 18
years-old
Gender - Male and Female
Key inclusion criteria - 1. Patients clinically indicated for cardiac MRI.
2. Age 18 years or older and under 90 years.
3. Subjects who have provided written informed consent for participation in the study.
Key exclusion criteria - 1. Patients with contraindications to MRI.
2. Patients with implanted pacemakers or implantable cardioverter-defibrillators (ICDs).
3. Pregnant or potentially pregnant women.
Target Size - 60
Recruitment Status:
Recruitment status - Enrolling by invitation
Date of protocol fixation - 2025 Year 06 Month 05 Day
Date of IRB - 2025 Year 07 Month 02 Day
Anticipated trial start date - 2025 Year 08 Month 01 Day
Last follow-up date - 2029 Year 06 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067071
Disclaimer: Curated by HT Syndication.
