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

June 21, 2016 updated by: National Heart Centre Singapore

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.

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

10

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 98 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with diagnosed Coronary Artery Disease

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Result of combining CT and CFD helps to provide 3D streamlines,pressure and non-invasive FFRCT.
Time Frame: Through study completion (09-May-2017)
Through study completion (09-May-2017)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Heart Centre Singapore

Investigators

  • Principal Investigator: A/Prof Tan Ru San, National Heart Centre Singapore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Anticipated)

May 1, 2017

Study Completion (Anticipated)

May 1, 2017

Study Registration Dates

First Submitted

May 31, 2016

First Submitted That Met QC Criteria

June 21, 2016

First Posted (Estimate)

June 22, 2016

Study Record Updates

Last Update Posted (Estimate)

June 22, 2016

Last Update Submitted That Met QC Criteria

June 21, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014/488/c

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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