Coronary Artery DiseaseNCT03021382
Comparisons of Morphological Measurement Between Coronary Computed Tomography and Optical Coherence Tomography
An observational study of Coronary Artery Disease, run by Kobe University at 1 site in Japan.
Trial summary
The objective of this study is to evaluate the precision of semi-automated lumen boundary identification from coronary computed tomography angiography (cCTA) by current version of HeartFlow software and the impact on fractional flow reserve (FFRCT) by using optical coherence tomography (OCT) as reference standard. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- data collection, non-intervention
- How many people
- 72 participants
- Where
- 1 siteJapan
- Study dates
- Jul 2016to Aug 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 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 72 vessels in 57 patients
Who may be able to join
- Patients who underwent cCTA prior to coronary angiography and OCT within 6 months.
Who cannot join
- Prior coronary artery bypass graft (CABG) surgery
- Contraindication to beta blocker agents or nitrates
- Tachycardia or significant arrhythmia
- Impaired chronic renal function (eGFR <30)
- Subjects with known anaphylactic allergy to iodinated contrast material
- Pregnancy or unknown pregnancy status in subject of childbearing potential
- Cases with poor OCT or CCTA image for analyzing
Trial locations and contacts
1 site in 1 country.
Japan1 site
Kobe University Graduate School of Medicine, Department of Cardiology
Kobe, Hyōgo, 650-0017
About this study
The objective of this study is to evaluate the precision of semi-automated lumen boundary identification from coronary computed tomography angiography (cCTA) by current version of HeartFlow software and the impact on fractional flow reserve (FFRCT) by using optical coherence tomography (OCT) as reference standard.
Read the detailed description
Analysis of cCTA and OCT was conducted under blind in independent organizations.
After unblinding the cCTA and OCT case identification number, the OCT image was co-registered to cCTA data.
After co-registration of cCTA and OCT lesion locations, the minimal lumen area (MLA) was detected with both modalities. FFROCT was calculated using OCT-updated models in which cCTA-based lumen geometry was replaced by OCT-based lumen geometry.
Lesions were grouped according to their severity of calcification (using Agatston score) and minimum lumen diameter.
- Conditions
- Coronary Artery Disease
- Being tested
- data collection, non-intervention
- 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.
data collection, non-interventionOther
| Study group | Role | What they receive |
|---|---|---|
| severity of calcification | All vessels were divided into tertile groups according to the severity of coronary calcification evaluated by the Agatston score. Receives: Other: data collection, non-intervention | |
| minimal lumen diameter (MLD) ≥1.0 mm | All lesions were divided according to an MLD ≥1.0 mm, and <1.0 mm by OCT in order to isolate the lesions which an MLD below the OCT catheter size. Receives: Other: data collection, non-intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between cCTA and OCT for MLA measurements
Measured: Immediately after OCT scan
Secondary outcomes (3)
Correlation between FFRCT and FFROCT
Measured: Immediately after OCT scan
Impact of calcification on the agreement of MLA between OCT and cCTA measurement
Measured: Immediately after OCT scan
Impact of calcification on the agreement of FFR between OCT and cCTA
Measured: Immediately after OCT scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2017 (estimated)
- Study startJul 2016
- Primary completionAug 2016
- Study completionAug 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
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kobe University
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- HeartFlow, Inc.
- Responsible party
- Principal investigator, Hiromasa Otake, Kobe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03021382
- Sponsor's protocol ID
- No.160040
- Status last verified
- Jan 2017
- First submitted
- 10 Jan 2017
- Last updated
- 13 Jan 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparisons of Morphological Measurement Between Coronary Computed Tomography and Optical Coherence Tomography
- ClinicalTrials.gov ID
- NCT03021382
- Acronym / sponsor ID
- No.160040
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Kobe UniversityIndustry (pharma, biotech, devices)
- Collaborators
- HeartFlow, Inc.
- Study start
- Jul 2016
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 13 Jan 2017 (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 objective of this study is to evaluate the precision of semi-automated lumen boundary identification from coronary computed tomography angiography (cCTA) by current version of HeartFlow software and the impact on fractional flow reserve (FFRCT) by using optical coherence tomography (OCT) as reference standard.
Detailed description
Analysis of cCTA and OCT was conducted under blind in independent organizations.
After unblinding the cCTA and OCT case identification number, the OCT image was co-registered to cCTA data.
After co-registration of cCTA and OCT lesion locations, the minimal lumen area (MLA) was detected with both modalities. FFROCT was calculated using OCT-updated models in which cCTA-based lumen geometry was replaced by OCT-based lumen geometry.
Lesions were grouped according to their severity of calcification (using Agatston score) and minimum lumen diameter.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| severity of calcification | – | Other: data collection, non-interventionAll vessels were divided into tertile groups according to the severity of coronary calcification evaluated by the Agatston score. |
| minimal lumen diameter (MLD) ≥1.0 mm | – | Other: data collection, non-interventionAll lesions were divided according to an MLD ≥1.0 mm, and <1.0 mm by OCT in order to isolate the lesions which an MLD below the OCT catheter size. |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 72 vessels in 57 patients
Key inclusion criteria (1 listed)
- Patients who underwent cCTA prior to coronary angiography and OCT within 6 months.
Key exclusion criteria (7 listed)
- Prior coronary artery bypass graft (CABG) surgery
- Contraindication to beta blocker agents or nitrates
- Tachycardia or significant arrhythmia
- Impaired chronic renal function (eGFR <30)
- Subjects with known anaphylactic allergy to iodinated contrast material
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 |
|---|---|---|
| data collection, non-intervention | Other | minimal lumen diameter (MLD) ≥1.0 mm, severity of calcification |
Primary outcome
Correlation between cCTA and OCT for MLA measurements
Time frame: Immediately after OCT scan
3 secondary outcomes
Correlation between FFRCT and FFROCT
Time frame: Immediately after OCT scan
Impact of calcification on the agreement of MLA between OCT and cCTA measurement
Time frame: Immediately after OCT scan
Impact of calcification on the agreement of FFR between OCT and cCTA
Time frame: Immediately after OCT scan
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 13 Jan 2017.
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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.
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 Artery Disease, run by Kobe University at 1 site in 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 1 inclusion and 7 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 13 Jan 2017. 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 Japan. 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?
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?
Correlation between cCTA and OCT for MLA measurements (time frame: Immediately after OCT scan). 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 13 Jan 2017.