Ignite Creation Date:
2024-05-06 @ 8:42 AM
Last Modification Date:
2024-10-26 @ 12:04 PM
Study NCT ID:
NCT02809157
Status:
UNKNOWN
Last Update Posted:
2016-06-22
First Post:
2016-05-31
Brief Title:
Non-invasive Fractional Flow Reserve CT FFRCTScan for the Study of Coronary Vaso-motion
Sponsor:
National Heart Centre Singapore
Organization:
National Heart Centre Singapore
Study Overview
Official Title:
Non-invasive Fractional Flow Reserve CT FFRCT Scan for the Study of Coronary Vaso-motion
Status:
UNKNOWN
Status Verified Date:
2016-05
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Coronary artery disease CAD is a very common cause of heart failure affecting millions of people worldwide which is caused by build-up of plaque inside arteries of the heart Build-up of plaque eventually impacts the blood supply to the heart In medicine techniques invasive or non-invasive such as coronary angiography intravascular ultrasound computed tomography magnetic resonance imaging positron emission tomography and transthoracic echocardiography can be used to diagnose CAD
The investigators aim to study Coronary Artery Disease significance with the combination of computed tomography angiography CTA and computational fluid dynamics CFD methods CTA is a non-invasive technique to visualize arterial vessels which uses computer-processed x-rays Computational Fluid Dynamics employs digital computers and numerical methods to solve complex flow patterns inside arterial vessels Combining these two methods the investigators are able to provide detailed blood flow information and mechanical stress distributions on the vessels This study therefore aims to propose a non-invasive methodology to assess the significance of CAD
The investigators aim to study Coronary Artery Disease significance with the combination of computed tomography angiography CTA and computational fluid dynamics CFD methods CTA is a non-invasive technique to visualize arterial vessels which uses computer-processed x-rays Computational Fluid Dynamics employs digital computers and numerical methods to solve complex flow patterns inside arterial vessels Combining these two methods the investigators are able to provide detailed blood flow information and mechanical stress distributions on the vessels This study therefore aims to propose a non-invasive methodology to assess the significance of CAD
Detailed Description:
Cardiovascular disease is the leading cause of death in Singapore and accounts for 319 of all deaths in 2010 Coronary vascular dysfunction has been linked to the development of cardiovascular-related events such as death myocardial infarction MI stroke and unstable angina Recently impaired coronary vaso-motion has been suggested as an independent predictor of poor prognosis which can predict cardiovascular events in patients with epicardial Coronary Artery Disease Coronary vaso-motion refers to the change in diameter of a coronary vessel in response to vasoactive agent which is measured via quantitative coronary angiography QCA Better coronary vaso-motion response has been associated with improved survival for both obstructive and non-obstructive CAD
Another widely used invasive clinical imaging technology to assess CAD is intravascular ultrasound IVUS which uses ultrasound technology for imaging the endothelium of vessels Since detailed histological information of plaques on the endothelium of coronary arteries can be provided by IVUS it is used as gold standard in evaluating progression or regression of plaque
Although coronary vaso-motion FFR and IVUS have been shown to improve clinical outcomes and procedural cost-efficiency in terms of guiding percutaneous interventions they are invasive procedures Non-invasive option for the diagnosis of myocardial ischemia is required to relief the patients pain and medical cost due to the invasive cath This study aims to fill in the gap The investigators hypothesize that non-invasive FFRCT can be obtained by combining CT images and CFD methods which can be used to assess the physiologic significance of CAD
Another widely used invasive clinical imaging technology to assess CAD is intravascular ultrasound IVUS which uses ultrasound technology for imaging the endothelium of vessels Since detailed histological information of plaques on the endothelium of coronary arteries can be provided by IVUS it is used as gold standard in evaluating progression or regression of plaque
Although coronary vaso-motion FFR and IVUS have been shown to improve clinical outcomes and procedural cost-efficiency in terms of guiding percutaneous interventions they are invasive procedures Non-invasive option for the diagnosis of myocardial ischemia is required to relief the patients pain and medical cost due to the invasive cath This study aims to fill in the gap The investigators hypothesize that non-invasive FFRCT can be obtained by combining CT images and CFD methods which can be used to assess the physiologic significance of CAD
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None