CT Coronary Angiography and Computational Fluid Dynamics

Coronary Artery Disease Clinical Trial

Official title:

Non-invasive Functional Assessment of Coronary Stenoses Using CT Coronary Angiography and Computational Fluid Dynamics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01189331
• Other study ID #: H-1007-193-325
• Status: Completed
• Phase: N/A
• Start date: October 13, 2009
• Est. completion date: December 31, 2020

Study information

• Verified date: March 2021
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Angiographically obtained fractional flow reserve(FFR) could provide functional and clinical information about stenotic lesion, but the invasiveness and measuring difficulty of FFR make it unfamiliar to perform. CT coronary angiography is non-invasive tool to evaluate lesion severity and lately developing computational fluid dynamics could provide functional information. The investigators build a patient specific model of computational fluid dynamics by CT coronary angiography and evaluate the functional significance by measuring fractional flow reserve via CT coronary angiography and computational fluid dynamics, and investigate its long-term prognostic implications.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Significant stenosis at CT angiography

• Normal ejection fraction on echocardiography

• Informed consented patient

Exclusion Criteria:

• total occlusion and collateral flow to target vessel

• AV conduction abnormality

• Left ventricular hypertrophy

• significant valvular heart or primary myocardial disease

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• CT coronary angiography and computational fluid dynamics
Evaluate coronary blood flow dynamics by CT coronary angiography and computational fluid dynamics

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (7)

Lead Sponsor	Collaborator
Seoul National University Hospital	Cornell University, Indiana University, Inje University, Pauls Stradins Clinical University Hospital, Stanford University, Ulsan university

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fractional flow reserve	fractional flow reserve of stenotic coronary artery	1day
Primary	target vessel failure	composite of cardiovascular death, target vessel myocardial infarction, target vessel revascularization	10 year