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.
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
Singapore1 site, 1 recruiting
- Recruiting
National Heart Centre Singapore
Singapore, Singapore, 169609
Ru San Tan, MBBS, tan.ru.san@nhcs.com.sg
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.
- Conditions
- Coronary Heart Disease
- 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.
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.
- First posted6 Jun 2016 (estimated)
- Study startMar 2014
- Primary completionJan 2017 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- National Heart Centre Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ru San Tan, MBBS, Principal investigator, National Heart Centre Singapore
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
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automatic Analysis of Coronary CT Angiography to Identify Patients With Significant Coronary Artery Stenosis for Clinical Decision-making.
- ClinicalTrials.gov ID
- NCT02791113
- Acronym / sponsor ID
- CTAAnalyzer / 2013/932/C
- Conditions
- Coronary Heart Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National Heart Centre SingaporeUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 6 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (2 listed)
- Aged 21-80 Years old
- Scheduled to undergo clinically-indicated non-emergent invasive catheterization angiography (ICA)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fractional Flow Reserve (FFR) MeasurementFFR 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. | Other | – |
Primary outcome
First occurrence of cardiovascular event
Time frame: 1 Year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ru San Tan, MBBS contact
Ru San Tan, MBBS principal investigator
National Heart Centre Singapore
1 site in 1 country: see every site and its status.
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.