AzTrials
AzTrials

Coronary Heart DiseaseCTAAnalyzerNCT02791113

Analysis of Coronary CT Angiography to Identify Patients With Significant Coronary Artery Stenosis

An observational study of Coronary Heart Disease, run by National Heart Centre Singapore at 1 site in 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 The sponsor has not verified this record for over two years, so it may be out of date.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
Search all trials

Trial summary

The investigators propose to develop a computational framework involving a novel automatic image segmentation algorithm based on CTA images, an artery model reconstruction algorithm for stenosis detection, and quantification of severity of stenosis in terms of area stenosis. Read more about this study

Who is it for?
Ages 21 to 80 years
Conditions the study is for
Coronary Heart Disease
What is being tested?
Fractional Flow Reserve (FFR) Measurement
How many people
50 participants
Where
1 siteSingapore
Study dates
Mar 2014to Jan 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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: 50 patients who is suspected of Coronary Heart Disease and has undergone Computed tomography angiography (CTA) procedure will be recruited for the study.

Who may be able to join

  • Aged 21-80 Years old
  • Scheduled to undergo clinically-indicated non-emergent invasive catheterization angiography (ICA)

Who cannot join

  • Individuals unable to provide informed consent
  • Non-cardiac illness with life expectancy <2years
  • Pregnant State
  • 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

Trial locations and contacts

1 site in 1 country.

Ru San Tan, MBBS contact

tan.ru.san@singhealth.com.sg

Singapore1 site, 1 recruiting
  • National Heart Centre Singapore

    Singapore, Singapore, 169609

    Ru San Tan, MBBS, tan.ru.san@nhcs.com.sg

    Recruiting

Other trials in Singapore

About this study

Official title: Automatic Analysis of Coronary CT Angiography to Identify Patients With Significant Coronary Artery Stenosis for Clinical Decision-making.

The investigators propose to develop a computational framework involving a novel automatic image segmentation algorithm based on CTA images, an artery model reconstruction algorithm for stenosis detection, and quantification of severity of stenosis in terms of area stenosis.

Read the detailed description

Coronary heart disease (CHD) is a common [affecting about 6% in the general adult population] cardiac disorder where a portion of the coronary artery is blocked. Among populations aged more than 65 years, the prevalence increases to 19.8%. The incidence of CHD in Singapore and other major countries is comparable. The prognosis of CHD is poor. CHD causes 1.2 million heart attacks and nearly 19% of deaths in US.[2] In Singapore, cardiovascular disease (CVD) accounted for 30.4% of all deaths in 2011, among these, 19% are due to CHD. In future, CVD deaths will increase up to 24.2 million globally in 2030. Among these, CHD deaths will change from 13.1% in 2010 to 14.9% in 2030 of all males; and from 13.6% to 13.1% of all females. The direct costs of CHD are estimated at over $87 billion and indirect cost at $70 billion in US. Unless current trends are halted or reversed, over a million people will die from CHD in US annually. Globally, the majority of CHD deaths will be in developing countries and many of the lives will be lost in middle age.

Invasive coronary angiography (ICA), is the gold standard method to delineate anatomical coronary stenosis. Fractional flow reserve (FFR) measurement with pressure wire is the gold standard for assessment of the physiological importance of an anatomical stenosis. Non-invasive computed tomography angiography (CTA), is a diagnostic alternative to invasive coronary angiography from single and multi-centre trials.

CTA enables visualization of coronary vessels in two-dimensional (2D) or three-dimensional (3D) formats. Current available imaging techniques on CTA are limited in their abilities in assessing physiological stenosis. First, the commonly used percent diameter stenosis to describe the extent of coronary artery stenosis is only a modest descriptor of coronary stenosis because it does not incorporate other lesion characteristics (e.g. length, shape and eccentricity) or the effect of stenosis in series that may greatly affect the blood flow. From our preliminary study, we found that diameter stenosis weakly correlated with golden standard FFR from invasive catheterization (r = 0.30). Second, percent diameter stenosis assessment is usually given per specific coronary artery lesion, the lesions being manually identified by the expert reader. There is no method to comprehensively assess the entire coronary tree in an automated fashion without the need for manual input. We propose the development of an Automatic CTA analyzer to identify significant coronary stenosis in coronary arteries that will provide rapid triage for patients suspected of CHD. This analyzer can also facilitate disease surveillance and monitoring of therapeutic efficacy.

The proposed integrated solution is expected to achieve earlier and higher accuracy in detecting severity of coronary stenosis. From 2004 to 2007 alone, the number of annual CTA procedures in the US is around 4.7 million. In National Heart Centre Singapore, we performed more than 1000 CTA per year.

Diameter stenosis from CTA cannot determine the hemodynamic significance of the coronary artery disease. For example, even if significant stenosis (>50%) is identified at CTA, fewer than 50% of the lesions actually cause ischemia. Furthermore, as many as 20% of patients with severe stenoses (i.e., >70%) on CTA turn out not to have ischemia confirmed by ICA and FFR. As a result, these patients risk of being referred for ICA when they do not need it.

Being tested
Fractional Flow Reserve (FFR) Measurement
Medical subject headings
Coronary Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fractional Flow Reserve (FFR) MeasurementOther

    FFR is defined as the distal pressure to coronary lesion divided by the proximal coronary pressure. FFR is measured through a standard diagnostic catheter during coronary angiogram. FFR is used to guide whether to perform angioplasty or stenting or not in patients with coronary stenosis.

What is being measured

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

  1. First occurrence of cardiovascular event

    Measured: 1 Year

Timeline

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

  1. First posted6 Jun 2016 (estimated)
  2. Study startMar 2014
  3. Primary completionJan 2017 (estimated)
  4. Study completionJan 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
Case only
Time perspective
Prospective
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02791113
Sponsor's protocol ID
2013/932/C
Acronym
CTAAnalyzer
Status last verified
May 2016
First submitted
31 May 2016
Last updated
15 Jun 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Heart Disease, run by National Heart Centre Singapore at 1 site in 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 8 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 15 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Contact Ru San Tan, MBBS (tan.ru.san@singhealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

First occurrence of cardiovascular event (time frame: 1 Year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 15 Jun 2016.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in