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Coronary Artery DiseaseNCT02809157

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

An observational study of Coronary Artery Disease, run by National Heart Centre Singapore.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 21 to 98 years
Conditions the study is for
Coronary Artery Disease
How many people
10 participants
Where
No sites listed yet
Study dates
Oct 2014to May 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 98 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with diagnosed Coronary Artery Disease

Who may be able to join

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

Who cannot join

  • 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).
Show all 14Show fewer
  • 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%

About this study

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

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.

Read the detailed 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.

Medical subject headings
Coronary Artery Disease

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Through study completion (09-May-2017)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2016 (estimated)
  2. Study startOct 2014
  3. Primary completionMay 2017 (estimated)
  4. Study completionMay 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02809157
Sponsor's protocol ID
2014/488/c
Status last verified
May 2016
First submitted
31 May 2016
Last updated
22 Jun 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 14970106

  • 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.

    PubMed 14522472

  • 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.

    PubMed 12818731

  • 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.

    PubMed 21213050

  • 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.

    PubMed 12163423

  • 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.

    PubMed 8462157

  • 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.

    PubMed 21788584

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease, run by National Heart Centre Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Result of combining CT and CFD helps to provide 3D streamlines,pressure and non-invasive FFRCT. (time frame: Through study completion (09-May-2017)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02809157, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2016.

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