Tomography, Optical CoherenceNCT04683133
The FAST OCT Study
A study testing Optical coherence tomography assessment in people with Tomography, Optical Coherence and Myocardial Revascularization, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
This trial is designed to associate angiography-based fractional flow reserve (3D-angio-based FFR) values with optical coherence tomography findings in pre- and post-percutaneous coronary intervention in patients with non-ST segment elevation acute coronary syndromes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tomography, Optical Coherence, Myocardial Revascularization, NSTEMI - Non-ST Segment Elevation MI
- What is being tested?
- Optical coherence tomography assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Dec 2020to 31 Dec 2021
- Phase
- Interventional
- 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
Who may be able to join
- 18 years or older
- Presenting with NST-ACS
- At least one coronary vessel with intermediate to severe coronary stenosis (30% to 90% by visual estimation or online QCA)
- Target vessel with a reference vessel diameter (RVD) ≥2.5 and ≤ 5.0 mm as assessed by QCA or visual estimation
- The patient is willing to participate in the study
- Target vessel suitable for OCT imaging
Who cannot join
- Target vessel with a distal Thrombolysis In Myocardial Infarction (TIMI) flow <3
- Target lesion located within 5.0 mm of vessel origin
- Severe tortuosity
- Chronic total occlusion of the target vessel
- Target lesion is located in or supplied by an arterial or venous bypass graft.
- Impaired renal function (eGFR <30ml/min) *
Show all 10Show fewer
- Pregnant or breastfeeding patients *
- Patient has a known allergy to contrast medium *
- Contraindication for the use of nitrates *
- Life expectancy <12 months
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Erasmus Medical Center
Rotterdam
Joost Daemen, MD;PhD, +31 10 703 5260, j.daemen@erasmusmc.nl
Maria Natalia Tovar Forero, MD, +31 10 703 8896, m.tovarforero@erasmusmc.nl
About this study
Official title: Association Between 3D Quantitative Angiography Based FFR and Luminal Obstruction as Detected by Optical Coherence Tomography (OCT): the FAST OCT Study
This trial is designed to associate angiography-based fractional flow reserve (3D-angio-based FFR) values with optical coherence tomography findings in pre- and post-percutaneous coronary intervention in patients with non-ST segment elevation acute coronary syndromes.
Read the detailed description
Prospective, multicenter, international, no-randomized, single-arm, investigator-initiated study, enrolling up to 200 patients with intermediate to severe coronary stenosis (30-90% diameter stenosis) in patients presenting with NST-ACS requiring coronary angiography assessment.
Patients will receive ad-hoc OCT evaluation of the target vessels and offline 3D-angio-based FFR evaluation.
The primary study parameter is the association between 3D-angio-based FFR values and OCT detected minimum luminal area pre- and post-PCI
- Conditions
- Tomography, Optical Coherence, Myocardial Revascularization, NSTEMI - Non-ST Segment Elevation MI, Unstable Angina, Coronary Arteriosclerosis, 3D-angio-based FFR
- Being tested
- Optical coherence tomography assessment
- Keywords
- OCT, 3D-angio-based FFR, Coronary Arteriosclerosis, NST-ACS
- Medical subject headings
- Non-ST Elevated Myocardial Infarction, Angina, Unstable, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical coherence tomography assessmentDiagnostic test
Optical coherence tomography assessment of coronary arteries with intermediate to severe stenosis
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Other | Optical coherence tomography evaluation of coronary arteries with intermediate to severe stenosis. Receives: Diagnostic Test: Optical coherence tomography assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The association between 3D-angio-based FFR and OCT detected minimum luminal area pre- and post-PCI
The association between 3D-angio-based FFR and OCT detected minimum luminal area pre- and post-PCI
Measured: 0 days
Secondary outcomes (4)
The association between 3D-angio-based FFR values and OCT detected causes of luminal obstruction pre-PCI
The association between 3D-angio-based FFR values and OCT detected causes of luminal obstruction pre-PCI
Measured: 0 days
The association between 3D-angio-based FFR values and OCT detected causes of luminal obstruction post-PCI
The association between 3D-angio-based FFR values and OCT detected causes of luminal obstruction post-PCI
Measured: 0 days
Accuracy of 3D-angio-based FFR to detect intraluminal obstructions pre-PCI
Accuracy of 3D-angio-based FFR to detect intraluminal obstructions pre-PCI
Measured: 0 days
Accuracy of 3D-angio-based FFR to detect intraluminal obstructions post-PCI
Accuracy of 3D-angio-based FFR to detect intraluminal obstructions post-PCI
Measured: 0 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2020
- Study start1 Dec 2020
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tomography, Optical CoherenceStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, multicenter, international, no-randomized, single-arm, investigator-initiated study
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott, Pie Medical Imaging
- Responsible party
- Principal investigator, Joost Daemen, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04683133
- Sponsor's protocol ID
- The FAST OCT study
- Status last verified
- Dec 2020
- First submitted
- 21 Dec 2020
- Last updated
- 24 Dec 2020
- Results posted
- No
- Data monitoring committee
- 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 24 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between 3D Quantitative Angiography Based FFR and Luminal Obstruction as Detected by Optical Coherence Tomography (OCT): the FAST OCT Study
- ClinicalTrials.gov ID
- NCT04683133
- Acronym / sponsor ID
- The FAST OCT study
- Conditions
- Tomography, Optical Coherence, Myocardial Revascularization, NSTEMI - Non-ST Segment Elevation MI, Unstable Angina, Coronary Arteriosclerosis, 3D-angio-based FFR
- Keywords
- OCT, 3D-angio-based FFR, Coronary Arteriosclerosis, NST-ACS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- Abbott, Pie Medical Imaging
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 24 Dec 2020 (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.
This trial is designed to associate angiography-based fractional flow reserve (3D-angio-based FFR) values with optical coherence tomography findings in pre- and post-percutaneous coronary intervention in patients with non-ST segment elevation acute coronary syndromes.
Detailed description
Prospective, multicenter, international, no-randomized, single-arm, investigator-initiated study, enrolling up to 200 patients with intermediate to severe coronary stenosis (30-90% diameter stenosis) in patients presenting with NST-ACS requiring coronary angiography assessment.
Patients will receive ad-hoc OCT evaluation of the target vessels and offline 3D-angio-based FFR evaluation.
The primary study parameter is the association between 3D-angio-based FFR values and OCT detected minimum luminal area pre- and post-PCI
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, multicenter, international, no-randomized, single-arm, investigator-initiated study
| Arm | Type | Receives |
|---|---|---|
| Single arm | Other | Diagnostic Test: Optical coherence tomography assessmentOptical coherence tomography evaluation of coronary arteries with intermediate to severe stenosis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years or older
- Presenting with NST-ACS
- At least one coronary vessel with intermediate to severe coronary stenosis (30% to 90% by visual estimation or online QCA)
- Target vessel with a reference vessel diameter (RVD) ≥2.5 and ≤ 5.0 mm as assessed by QCA or visual estimation
- The patient is willing to participate in the study
Key exclusion criteria (10 listed)
- Target vessel with a distal Thrombolysis In Myocardial Infarction (TIMI) flow <3
- Target lesion located within 5.0 mm of vessel origin
- Severe tortuosity
- Chronic total occlusion of the target vessel
- Target lesion is located in or supplied by an arterial or venous bypass graft.
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 |
|---|---|---|
| Optical coherence tomography assessmentOptical coherence tomography assessment of coronary arteries with intermediate to severe stenosis | Diagnostic test | Single arm |
Primary outcome
The association between 3D-angio-based FFR and OCT detected minimum luminal area pre- and post-PCI
Time frame: 0 days
The association between 3D-angio-based FFR and OCT detected minimum luminal area pre- and post-PCI
4 secondary outcomes
The association between 3D-angio-based FFR values and OCT detected causes of luminal obstruction pre-PCI
Time frame: 0 days
The association between 3D-angio-based FFR values and OCT detected causes of luminal obstruction post-PCI
Time frame: 0 days
Accuracy of 3D-angio-based FFR to detect intraluminal obstructions pre-PCI
Time frame: 0 days
Accuracy of 3D-angio-based FFR to detect intraluminal obstructions post-PCI
Time frame: 0 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2020.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optical coherence tomography assessment in people with Tomography, Optical Coherence and Myocardial Revascularization, run by Erasmus Medical Center 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 6 inclusion and 10 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 24 Dec 2020. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The association between 3D-angio-based FFR and OCT detected minimum luminal area pre- and post-PCI (time frame: 0 days). 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 24 Dec 2020.