Non-invasive Fractional Flow Reserve CT (FFRCT)Scan for the Study of Coronary Vaso-motion

Coronary Artery Disease Clinical Trial

Official title:

Non-invasive Fractional Flow Reserve CT (FFRCT) Scan for the Study of Coronary Vaso-motion

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02809157
• Other study ID #: 2014/488/c
• Status: Active, not recruiting
• Phase: N/A
• First received: May 31, 2016
• Last updated: June 21, 2016
• Start date: October 2014
• Est. completion date: May 2017

Study information

• Verified date: May 2016
• Source: National Heart Centre Singapore
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Description:

Cardiovascular disease is the leading cause of death in Singapore, and accounts for 31.9% 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 98 Years

Eligibility

Inclusion Criteria:

1. Aged 21-98.

2. Undergoing coronary angiography, who had received coronary CTA within 2 months before the scheduled coronary angiography.

Exclusion Criteria:

1. Individuals unable to provide informed consent.

2. Non-cardiac illness with life expectancy <2 years.

3. Pregnant or breastfeeding state. Female patients who have a chance of becoming pregnant will receive pregnancy testing to exclude pregnant women from entering the study.

4. Allergy to iodinated contrast.

5. Significant arrhythmia; heart rate = 100 beats/min; systolic blood pressure =90 mmHg.

6. Renal dysfunction (Glomerular filtration rate (GFR) <30 mL/min/1.73m2).

7. Contraindication to beta blockers or nitroglycerin.

8. Canadian Cardiovascular Society class IV angina.

9. Significant valvular pathology

10. Previous coronary artery bypass surgery

11. Previous Percutaneous coronary intervention

12. Contraindication to adenosine administration (e.g. asthma, chronic obstructive pulmonary disease, heart rate <50 beats/min)

13. Patients with an acute myocardial infarction or unstable arrhythmias

14. Patients with a left ventricular ejection fraction less than 30%

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Heart Centre Singapore

References & Publications (7)

Halcox JP, Schenke WH, Zalos G, Mincemoyer R, Prasad A, Waclawiw MA, Nour KR, Quyyumi AA. Prognostic value of coronary vascular endothelial dysfunction. Circulation. 2002 Aug 6;106(6):653-8. — View Citation

Pijls NH, van Son JA, Kirkeeide RL, De Bruyne B, Gould KL. Experimental basis of determining maximum coronary, myocardial, and collateral blood flow by pressure measurements for assessing functional stenosis severity before and after percutaneous transluminal coronary angioplasty. Circulation. 1993 Apr;87(4):1354-67. — View Citation

Quyyumi AA. Prognostic value of endothelial function. Am J Cardiol. 2003 Jun 19;91(12A):19H-24H. Review. — View Citation

Samady H, Eshtehardi P, McDaniel MC, Suo J, Dhawan SS, Maynard C, Timmins LH, Quyyumi AA, Giddens DP. Coronary artery wall shear stress is associated with progression and transformation of atherosclerotic plaque and arterial remodeling in patients with coronary artery disease. Circulation. 2011 Aug 16;124(7):779-88. doi: 10.1161/CIRCULATIONAHA.111.021824. Epub 2011 Jul 25. — View Citation

Sarno G, Bruining N, Onuma Y, Garg S, Brugaletta S, De Winter S, Regar E, Thuesen L, Dudek D, Veldhof S, Dorange C, Garcia-Garcia HM, Ormiston JA, Serruys PW. Morphological and functional evaluation of the bioresorption of the bioresorbable everolimus-eluting vascular scaffold using IVUS, echogenicity and vasomotion testing at two year follow-up: a patient level insight into the ABSORB A clinical trial. Int J Cardiovasc Imaging. 2012 Jan;28(1):51-8. doi: 10.1007/s10554-010-9769-y. Epub 2011 Jan 7. — View Citation

von Mering GO, Arant CB, Wessel TR, McGorray SP, Bairey Merz CN, Sharaf BL, Smith KM, Olson MB, Johnson BD, Sopko G, Handberg E, Pepine CJ, Kerensky RA; National Heart, Lung, and Blood Institute. Abnormal coronary vasomotion as a prognostic indicator of cardiovascular events in women: results from the National Heart, Lung, and Blood Institute-Sponsored Women's Ischemia Syndrome Evaluation (WISE). Circulation. 2004 Feb 17;109(6):722-5. — View Citation

Widlansky ME, Gokce N, Keaney JF Jr, Vita JA. The clinical implications of endothelial dysfunction. J Am Coll Cardiol. 2003 Oct 1;42(7):1149-60. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Result of combining CT and CFD helps to provide 3D streamlines,pressure and non-invasive FFRCT.		Through study completion (09-May-2017)	No

External Links

•   Report on Registration of Births and Deaths in 2011 by the Registry of Births and Deaths,Immigration and Checkpoints Authority,Singapore