Coronary StenosisCLARITYNCT03139006
Application of speCtraL Computed tomogrAphy to impRove specIficity of Cardiac compuTed tomographY
An observational study of Coronary Stenosis and Myocardial Ischemia, run by UMC Utrecht at 1 site in Netherlands.
Trial summary
Cardiovascular disease remains the leading cause of morbidity and mortality worldwide. Coronary computed tomography angiography (CCTA) and, if indicated, invasively measured fractional flow reserve (FFR) is currently used for ruling out significant coronary artery disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Stenosis, Myocardial Ischemia, Cardiovascular Diseases
- What is being tested?
- Dual-layer spectral detector CT
- Type of treatment
- Medical device
- How many people
- 75 participants
- Where
- 1 siteNetherlands
- Study dates
- 29 Mar 2017to 1 Sep 2021
- How long will I take part?
- 1 Day
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants ≥18 years of age with suspected or known stable angina with pre-test likelihood of 50-85% for obstructive coronary disease (Eur Heart J 2013 guidelines on stable CAD) and who are referred for clinical invasive FFR.
Who may be able to join
- ≥18 years old;
- Suspected or known stable angina with pre-test likelihood of 50-85% for obstructive coronary disease, using the method recommended by the European Society of Cardiology 2013 Guidelines on the management of stable coronary artery disease (Eur Heart J 2013);
- Referred for invasive testing with fractional flow reserve;
- Willing and able to give informed consent. The consent procedures, as set by the Institutional Review Board (IRB) will be followed.
Who cannot join
- Subjects with suspected or known stable angina with pre-test likelihood of 0-50% using the method recommended by the European Society of Cardiology 2013 Guidelines on the management of stable coronary artery disease (Eur Heart J 2013 [24]);
- Subjects who because of age, general medical or psychiatric condition, or physiologic status cannot give valid informed consent or tolerate the coronary CTA examination;
- Subjects with (severe) renal insufficiency, indicated as glomerular filtration rate (GFR) <60 ml/min;
- Subjects with unknown GFR or obtained >3 months before the planned scan;
- Contraindication or allergy to intravenous contrast agent(s);
- Subjects who participate in an other study with radiation which is estimated to be in risk category III (ICRP 62);
- Subjects who are pregnant;
- Subjects with contraindications to cardiac CT and/or S\&S protocol, intravenous contrast, intravenous adenosine, betablockers or nitroglycerine.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
University Medical Center UtrechtU
Utrecht, 3508GA
Robbert van Hamersvelt, MD, +31887550441, R.W.vanHamersvelt-3@umcutrecht.nl
Tim Leiner, MD, PhD
About this study
Official title: Diagnostic Accuracy of Spectral Computed Tomography for Detection of Flow Limiting Coronary Stenosis Using Fractional Flow Reserve as the Standard of Reference
Cardiovascular disease remains the leading cause of morbidity and mortality worldwide. Coronary computed tomography angiography (CCTA) and, if indicated, invasively measured fractional flow reserve (FFR) is currently used for ruling out significant coronary artery disease. FFRCT is a novel non-invasive technique in which FFR is derived from CT images, however this method is currently, just like CCTA, lacking specificity. Spectral Detector CT (SDCT) is a novel technique whereby a spectrum of monoenergetic images at different kiloelectron Volt (keV) values (40 to 200 keV) can be reconstructed. By using these monoenergetic images, a decrease in blooming and beam-hardening artifacts could be achieved. In addition, SDCT offers the opportunity to assess myocardial iodine distribution and quantification. When combining these factors, we hypothesize more accurate information will be available about the coronary anatomy, degree of stenosis and FFRCT and thereby contribute to a more accurate way for the detection of hemodynamic significant stenosis. Therefore, the aim of this study is to assess the accuracy of SDCT as a non-invasive way for the detection of hemodynamically significant coronary artery stenosis.
Objective: The overall objective of this project is to assess the accuracy of SDCT for the detection of flow limiting stenosis in the coronary arteries using invasive FFR as the standard of reference. Whereby different sub-aims (e.g. improvement of FFRCT) are made to answer the overall objective. The secondary objective is to determine the decrease of calcium blooming of calcifications and beam-hardening artifacts and the improvement of myocardial blood volume quantification on SDCT in comparison with conventional CT.
- Being tested
- Dual-layer spectral detector CT
- Medical subject headings
- Coronary Stenosis, Myocardial Ischemia, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual-layer spectral detector CTDevice
Also called SDCT
A dual energy CT approach
What is being measured
The primary outcome is the main question the study is designed to answer.
Flow limiting stenosis in the coronary arteries defined by invasive fractional flow reserve (FFR)
An invasive FFR <0.8 indicates a flow limiting stenosis
Measured: within 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2017
- Study start29 Mar 2017
- Primary completion29 Mar 2021 (estimated)
- Study completion1 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary StenosisStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tim Leiner, UMC Utrecht
- Investigators
- Tim Leiner, MD, PhD, Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03139006
- Sponsor's protocol ID
- NL55917.041.16
- Acronym
- CLARITY
- Status last verified
- Oct 2018
- First submitted
- 1 May 2017
- Last updated
- 17 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
van Hamersvelt RW, Isgum I, de Jong PA, Cramer MJM, Leenders GEH, Willemink MJ, Voskuil M, Leiner T. Application of speCtraL computed tomogrAphy to impRove specIficity of cardiac compuTed tomographY (CLARITY study): rationale and design. BMJ Open. 2019 Mar 1;9(3):e025793. doi: 10.1136/bmjopen-2018-025793.
PubMed 30826767
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of Spectral Computed Tomography for Detection of Flow Limiting Coronary Stenosis Using Fractional Flow Reserve as the Standard of Reference
- ClinicalTrials.gov ID
- NCT03139006
- Acronym / sponsor ID
- CLARITY / NL55917.041.16
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Study start
- 29 Mar 2017 (actual)
- Primary completion
- 29 Mar 2021 (estimated)
- Study completion
- 1 Sep 2021 (estimated)
- First posted
- 3 May 2017 (actual)
- 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.
Cardiovascular disease remains the leading cause of morbidity and mortality worldwide. Coronary computed tomography angiography (CCTA) and, if indicated, invasively measured fractional flow reserve (FFR) is currently used for ruling out significant coronary artery disease. FFRCT is a novel non-invasive technique in which FFR is derived from CT images, however this method is currently, just like CCTA, lacking specificity. Spectral Detector CT (SDCT) is a novel technique whereby a spectrum of monoenergetic images at different kiloelectron Volt (keV) values (40 to 200 keV) can be reconstructed. By using these monoenergetic images, a decrease in blooming and beam-hardening artifacts could be achieved. In addition, SDCT offers the opportunity to assess myocardial iodine distribution and quantification. When combining these factors, we hypothesize more accurate information will be available about the coronary anatomy, degree of stenosis and FFRCT and thereby contribute to a more accurate way for the detection of hemodynamic significant stenosis. Therefore, the aim of this study is to assess the accuracy of SDCT as a non-invasive way for the detection of hemodynamically significant coronary artery stenosis.
Objective: The overall objective of this project is to assess the accuracy of SDCT for the detection of flow limiting stenosis in the coronary arteries using invasive FFR as the standard of reference. Whereby different sub-aims (e.g. improvement of FFRCT) are made to answer the overall objective. The secondary objective is to determine the decrease of calcium blooming of calcifications and beam-hardening artifacts and the improvement of myocardial blood volume quantification on SDCT in comparison with conventional CT.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants ≥18 years of age with suspected or known stable angina with pre-test likelihood of 50-85% for obstructive coronary disease (Eur Heart J 2013 guidelines on stable CAD) and who are referred for clinical invasive FFR.
Key inclusion criteria (4 listed)
- ≥18 years old;
- Suspected or known stable angina with pre-test likelihood of 50-85% for obstructive coronary disease, using the method recommended by the European Society of Cardiology 2013 Guidelines on the management of stable coronary artery disease (Eur Heart J 2013);
- Referred for invasive testing with fractional flow reserve;
- Willing and able to give informed consent. The consent procedures, as set by the Institutional Review Board (IRB) will be followed.
Key exclusion criteria (8 listed)
- Subjects with suspected or known stable angina with pre-test likelihood of 0-50% using the method recommended by the European Society of Cardiology 2013 Guidelines on the management of stable coronary artery disease (Eur Heart J 2013 [24]);
- Subjects who because of age, general medical or psychiatric condition, or physiologic status cannot give valid informed consent or tolerate the coronary CTA examination;
- Subjects with (severe) renal insufficiency, indicated as glomerular filtration rate (GFR) <60 ml/min;
- Subjects with unknown GFR or obtained >3 months before the planned scan;
- Contraindication or allergy to intravenous contrast agent(s);
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 |
|---|---|---|
| Dual-layer spectral detector CTAlso: SDCTA dual energy CT approach | Device | – |
Primary outcome
Flow limiting stenosis in the coronary arteries defined by invasive fractional flow reserve (FFR)
Time frame: within 30 days
An invasive FFR <0.8 indicates a flow limiting stenosis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2018.
- Derived from this study: PubMed 30826767van Hamersvelt RW, Isgum I, de Jong PA, Cramer MJM, Leenders GEH, Willemink MJ, Voskuil M, Leiner T. Application of speCtraL computed tomogrAphy to impRove specIficity of cardiac compuTed tomographY (CLARITY study): rationale and design. BMJ Open. 2019 Mar 1;9(3):e025793. doi: 10.1136/bmjopen-2018-025793.
- 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.
Tim Leiner, MD, PhD principal investigator
UMC Utrecht
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 Stenosis and Myocardial Ischemia, run by UMC Utrecht at 1 site in Netherlands.
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 4 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 17 Oct 2018. 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 Netherlands. 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 Robbert van Hamersvelt, MD (+31887550441, R.W.vanHamersvelt-3@umcutrecht.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Flow limiting stenosis in the coronary arteries defined by invasive fractional flow reserve (FFR) (time frame: within 30 days). 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 NCT03139006, which also lists 1 linked publication.
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 17 Oct 2018.