Optical Coherence Tomography (OCT)NCT03229993
OCT in Borderline Coronary Artery Lesions
A study testing OCT in people with Optical Coherence Tomography (OCT) and Percutaneous Coronary Intervention (PCI), run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
To find out the safety and efficacy of Optical Coherence Tomography (OCT) in the evaluation and treatment of angiographically borderline coronary artery lesions in a Chinese population, and to compare the effectiveness of OCT versus SPECT in treating such subjects. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Optical Coherence Tomography (OCT), Percutaneous Coronary Intervention (PCI), Single-Photon Emission Computed Tomography (SPECT)
- What is being tested?
- OCT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteChina
- Study dates
- 31 Dec 2017to 31 Dec 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The inclusion criteria for this study will be only those participants in whom diagnostic coronary angiography revealed borderline coronary artery lesion. These participants will undergo the OCT procedure, or alternatively ECT.
Who cannot join
- Exclusion criteria will be those participants with previous cardiogenic shock, stroke, renal dysfunction, and acute or chronic total occlusion coronary lesions.
Trial locations and contacts
1 site in 1 country.
China1 site
First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029
About this study
Official title: The Safety and Efficacy of OCT in the Evaluation and Treatment of Angiographically Borderline Coronary Artery Lesions
To find out the safety and efficacy of Optical Coherence Tomography (OCT) in the evaluation and treatment of angiographically borderline coronary artery lesions in a Chinese population, and to compare the effectiveness of OCT versus SPECT in treating such subjects. All the participants included in the study will be those that are found to have borderline coronary artery lesions on coronary angiography, in whom the investigators feel that OCT will be useful to assess whether PCI will be of benefit to the treatment of the lesion pathology, or whether optimal medical therapy is the most appropriate treatment modality. Those participants who declined OCT will be offered SPECT as an alternative method to assess and treat the borderline coronary artery stenosis.
It is estimated that OCT guided "PCI or not" has a non-inferiority to SPECT's in the borderline coronary artery stenosis.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCTDiagnostic test
OCT is used to assess whether PCI will be of benefit to the treatment of the borderline coronary artery lesions
| Study group | Role | What they receive |
|---|---|---|
| OCT guided PCI | Experimental | Not described Receives: Diagnostic Test: OCT |
| OCT guided medicine | Experimental | Not described Receives: Diagnostic Test: OCT |
| SPECT guided PCI | No intervention | Not described |
| SPECT guided medicine | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
MACEs
The incidence of major adverse cardiac events (MACEs) including death, myocardial infarction, and stent thrombosis.
Measured: 12 months
TLR
The incidence of target lesion revascularization (TLR)
Measured: 12 months
Secondary outcomes (2)
Rehospitalization
The incidence of rehospitalization due to cardiac events
Measured: 12 months
Recurrent angina
The incidence of recurrent angina
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2017
- Study start31 Dec 2017
- Primary completion31 Jan 2018
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Optical Coherence Tomography (OCT)Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03229993
- Sponsor's protocol ID
- OCT-20170723
- Status last verified
- Jul 2020
- First submitted
- 23 Jul 2017
- Last updated
- 17 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy of OCT in the Evaluation and Treatment of Angiographically Borderline Coronary Artery Lesions
- ClinicalTrials.gov ID
- NCT03229993
- Acronym / sponsor ID
- OCT-20170723
- Conditions
- Optical Coherence Tomography (OCT), Percutaneous Coronary Intervention (PCI), Single-Photon Emission Computed Tomography (SPECT), Coronary Angiography (CAG), Borderline Coronary Artery Lesions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 31 Dec 2017 (actual)
- Primary completion
- 31 Jan 2018 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 26 Jul 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.
To find out the safety and efficacy of Optical Coherence Tomography (OCT) in the evaluation and treatment of angiographically borderline coronary artery lesions in a Chinese population, and to compare the effectiveness of OCT versus SPECT in treating such subjects. All the participants included in the study will be those that are found to have borderline coronary artery lesions on coronary angiography, in whom the investigators feel that OCT will be useful to assess whether PCI will be of benefit to the treatment of the lesion pathology, or whether optimal medical therapy is the most appropriate treatment modality. Those participants who declined OCT will be offered SPECT as an alternative method to assess and treat the borderline coronary artery stenosis.
It is estimated that OCT guided "PCI or not" has a non-inferiority to SPECT's in the borderline coronary artery stenosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| OCT guided PCI | Experimental | Diagnostic Test: OCT |
| OCT guided medicine | Experimental | Diagnostic Test: OCT |
| SPECT guided PCI | No intervention | – |
| SPECT guided medicine | No intervention | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- The inclusion criteria for this study will be only those participants in whom diagnostic coronary angiography revealed borderline coronary artery lesion. These participants will undergo the OCT procedure, or alternatively ECT.
Key exclusion criteria (1 listed)
- Exclusion criteria will be those participants with previous cardiogenic shock, stroke, renal dysfunction, and acute or chronic total occlusion coronary lesions.
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 |
|---|---|---|
| OCTOCT is used to assess whether PCI will be of benefit to the treatment of the borderline coronary artery lesions | Diagnostic test | OCT guided PCI, OCT guided medicine |
Primary outcome
MACEs
Time frame: 12 months
The incidence of major adverse cardiac events (MACEs) including death, myocardial infarction, and stent thrombosis.
TLR
Time frame: 12 months
The incidence of target lesion revascularization (TLR)
2 secondary outcomes
Rehospitalization
Time frame: 12 months
Recurrent angina
Time frame: 12 months
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 17 Jul 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Optical Coherence Tomography (OCT)
RecruitingObservational study
The Value of Measuring Retinal Vascular Density by Optical Coherence Tomography-Angiography (OCT-A) in Patients With Microvascular Angina Confirmed by Myocardial Microcirculatory Resistance Index (MRI).
Microvascular Angina
Active, not recruitingObservational study
Assessment of NfL and GFAP Levels, Atrophy of the Macula GCC by OCT and Whole Brain Atrophy by MRI to Predict Evolution of Neurological Disability in MS Patients
Multiple Sclerosis
Active, not recruiting
Interventional Strategy for Non-culprit Lesions With Major Vulnerability Criteria at OCT in Patients With ACS
Coronary Artery Disease, Coronary Disease
Not yet recruiting
Optical Coherence Tomography-Assisted Strategy for Interventional Management of Symptomatic Carotid Stenosis (OASIS-C)
Carotid Stenosis
Not yet recruiting
Rapid Inflation/Deflation Compared With Prolonged High-Pressure Balloon Inflation
Coronary Artery Disease, Coronary Stent Occlusion
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?
A study testing OCT in people with Optical Coherence Tomography (OCT) and Percutaneous Coronary Intervention (PCI), run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
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 1 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 17 Jul 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 China. 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?
MACEs (time frame: 12 months). The study lists 2 primary outcomes in all. 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 17 Jul 2020.