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

NCT02809157 | Unknown

• 1 other identifier: 2014/488/c
• Study Type: observational
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Result of combining CT and CFD helps to provide 3D streamlines,pressure and non-invasive FFRCT.

  Through study completion (09-May-2017)

Eligibility Criteria

• Age: 21 Years - 98 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with diagnosed Coronary Artery Disease

You may qualify if:

• Aged 21-98.
• Undergoing coronary angiography, who had received coronary CTA within 2 months before the scheduled coronary angiography.

You may not qualify if:

• Individuals unable to provide informed consent.
• Non-cardiac illness with life expectancy \<2 years.
• 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.
• Allergy to iodinated contrast.
• Significant arrhythmia; heart rate ≥ 100 beats/min; systolic blood pressure ≤90 mmHg.
• Renal dysfunction (Glomerular filtration rate (GFR) \<30 mL/min/1.73m2).
• Contraindication to beta blockers or nitroglycerin.
• Canadian Cardiovascular Society class IV angina.
• Significant valvular pathology
• Previous coronary artery bypass surgery
• Previous Percutaneous coronary intervention
• Contraindication to adenosine administration (e.g. asthma, chronic obstructive pulmonary disease, heart rate \<50 beats/min)
• Patients with an acute myocardial infarction or unstable arrhythmias
• Patients with a left ventricular ejection fraction less than 30%

Sponsors & Collaborators

• National Heart Centre Singapore: lead

Related Publications (7)

• 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. doi: 10.1161/01.CIR.0000115525.92645.16.

  PMID: 14970106 BACKGROUND

• 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. doi: 10.1016/s0735-1097(03)00994-x.

  PMID: 14522472 BACKGROUND

• Quyyumi AA. Prognostic value of endothelial function. Am J Cardiol. 2003 Jun 19;91(12A):19H-24H. doi: 10.1016/s0002-9149(03)00430-2.

  PMID: 12818731 BACKGROUND

• 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.

  PMID: 21213050 BACKGROUND

• 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. doi: 10.1161/01.cir.0000025404.78001.d8.

  PMID: 12163423 BACKGROUND

• 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. doi: 10.1161/01.cir.87.4.1354.

  PMID: 8462157 BACKGROUND

• 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.

  PMID: 21788584 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• A/Prof Tan Ru San

  National Heart Centre Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2016
• First Posted: June 22, 2016
• Study Start: October 1, 2014
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: June 22, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share