Tokyo, June 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061877) titled 'Clinical study of the utility of coronary computed tomography angiography findings including extracellular volume fraction in patients with cardiovascular disease' on June 15.
Study Type:
Observational
Primary Sponsor:
Institute - Tsuchiura Kyodo General Hospital
Condition:
Condition - Cardiovascular disease
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - Coronary CT angiography is traditionally recommended as a screening test for patients with low-intermediate risk of coronary artery disease. It is renowned for its ability to provide an excellent anatomical assessment of the coronary arteries and its high negative predictive value. While assessing plaque morphology and calcification has been possible for some time, it has only recently become feasible to conduct qualitative evaluations of the coronary arteries and myocardium. This enables the evaluation of inflammation through the pericoronary fat attenuation index (FAI), as well as the assessment of fibrosis and oedema using the extracellular volume fraction (ECV). However, as the relationship between these indicators and patient profiles, echocardiographic findings, coronary catheter findings and prognosis has not yet been fully verified, we will investigate their clinical significance.
Basic objectives2 - Efficacy
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Patients with or suspected to cardiovascular disease.
Key exclusion criteria - Patients who could not undergo coronary CT angiography due to renal impairment, contrast agent allergy, or other reasons
Target Size - 3000
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2023 Year 03 Month 01 Day
Date of IRB - 2024 Year 02 Month 27 Day
Anticipated trial start date - 2023 Year 03 Month 01 Day
Last follow-up date - 2033 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070803
Disclaimer: Curated by HT Syndication.