Coronary Artery DiseaseNCT03055780
Diagnostic Accuracy to Detect Hemodynamically Significant Stenosis by Non-invasive SURECardio CT-FFR
An observational study of Coronary Artery Disease, run by Toshiba Medical Systems Corporation, Japan.
Trial summary
The aim of this study was to determine the diagnostic accuracy of SURECardio CT-FFR to detect functionally significant coronary stenosis. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- CT-FFR. CTA. FFR
- Type of treatment
- Medical device
- How many people
- 59 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2015to 1 Oct 2016
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Suspected coronary artery disease
Who may be able to join
- suspected coronary artery disease
- hemodynamically stable condition
Who cannot join
- hemodynamic instability
- atrial fibrillation
- morbid obesity (BMI≥40 kg/m2)
- previous stent implantation
- recent myocardial infarction (within 30 days)
- age <40 years
- renal insufficiency (eGFR <60mL/min/1.73m2)
- bronchospastic lung disease requiring long term steroid therapy
About this study
Official title: Clinical Trial for SURECardio CT-FFR
The aim of this study was to determine the diagnostic accuracy of SURECardio CT-FFR to detect functionally significant coronary stenosis.
Read the detailed description
CT acquision and invasive FFR measurement is performed for each patients. The diagnostic accuracy of coronary CTA and SURECardio CT-FFR is investigated using Invasive FFR is used as the reference standard.
- Conditions
- Coronary Artery Disease
- Being tested
- CT-FFR. CTA. FFR
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-FFR. CTA. FFRDevice
Study is to compare results of CT FFR against CTA and interventional FFR
| Study group | Role | What they receive |
|---|---|---|
| CT-FFR. CTA. FFR | 59 patients with suspected CAD that have been scheduled for an interventional FFR study Receives: Device: CT-FFR. CTA. FFR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of SURECardio CT-FFR to detect functionally significant coronary stenosis
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2017
- Study start1 Jul 2015
- Primary completion30 May 2016
- Study completion1 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Toshiba Medical Systems Corporation, Japan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03055780
- Sponsor's protocol ID
- SGD03-0667
- Status last verified
- Feb 2017
- First submitted
- 14 Feb 2017
- Last updated
- 16 Feb 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial for SURECardio CT-FFR
- ClinicalTrials.gov ID
- NCT03055780
- Acronym / sponsor ID
- SGD03-0667
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Toshiba Medical Systems Corporation, JapanIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2015 (actual)
- Primary completion
- 30 May 2016 (actual)
- Study completion
- 1 Oct 2016 (actual)
- First posted
- 16 Feb 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.
The aim of this study was to determine the diagnostic accuracy of SURECardio CT-FFR to detect functionally significant coronary stenosis.
Detailed description
CT acquision and invasive FFR measurement is performed for each patients. The diagnostic accuracy of coronary CTA and SURECardio CT-FFR is investigated using Invasive FFR is used as the reference standard.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CT-FFR. CTA. FFR | – | Device: CT-FFR. CTA. FFR59 patients with suspected CAD that have been scheduled for an interventional FFR study |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Suspected coronary artery disease
Key inclusion criteria (2 listed)
- suspected coronary artery disease
- hemodynamically stable condition
Key exclusion criteria (8 listed)
- hemodynamic instability
- atrial fibrillation
- morbid obesity (BMI≥40 kg/m2)
- previous stent implantation
- recent myocardial infarction (within 30 days)
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 |
|---|---|---|
| CT-FFR. CTA. FFRStudy is to compare results of CT FFR against CTA and interventional FFR | Device | CT-FFR. CTA. FFR |
Primary outcome
Sensitivity and specificity of SURECardio CT-FFR to detect functionally significant coronary stenosis
Time frame: one day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2017.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Toshiba Medical Systems Corporation, Japan.
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: finished, as of the sponsor's last update on 16 Feb 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Sensitivity and specificity of SURECardio CT-FFR to detect functionally significant coronary stenosis (time frame: one day). 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 16 Feb 2017.