Coronary Artery Disease Acute Coronary Syndrome Myocardial Ischemia Plaque CharacterizationNCT05750082
The AIPLAQUE Study: An Artificial Intelligence-based Prospective Study to Analyze PLAQUE Using CCTA
An observational study of Coronary Artery Disease Acute Coronary Syndrome Myocardial Ischemia Plaque Characterization, run by Harbin Medical University at 1 site in China.
Trial summary
This trial is a single-center, prospective, observational clinical study. All patients who have at least one coronary artery stenosis of 30%-90% in diameter ≥ 2mm confirmed by CCTA, and who are scheduled to undergo clinically indicated invasive coronary angiography (ICA) and optical coherence tomography (OCT)… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease Acute Coronary Syndrome Myocardial Ischemia Plaque Characterization
- What is being tested?
- CCTA CT-FR CAG OCT
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 12 Apr 2021to 1 Dec 2023
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population comprised 100 stable patients with angina pectoris or acute coronary syndrome who will receive CCTA, CT-FFR, ICA, and OCT.
Who may be able to join
- Age ≥18 years and able to understand the purpose of the study and sign the informed consent;
- Patients who presented with stable angina pectoris or acute coronary syndrome;
- Patients who meet the indications for coronary CT angiography, percutaneous coronary angiography and intravascular imaging;
- Among those patients, patients who have at least one coronary artery stenosis of 30% - 90% in diameter ≥ 2mm confirmed by CCTA.
Who cannot join
- Known pregnancy or breastfeeding at the time of enrollment;
- Hemodynamic instability;
- Allergy to contrast media or aspirin, adenosine etc.;
- History of stroke or transient ischemic attack (TIA) within 12 months before surgery;
- Known renal insufficiency (e.g. serum creatinine >2.0mg/dL, or creatinine clearance ≤30 mL/min), or need for dialysis, or acute kidney failure (as per physician judgment);
- Leukopenia (WBC<4.0*10*9/L), thrombocytopenia (PLT<100*10*9/L) or thrombocytopenia (PLT>300*10*9/L);
- Subjects who receiving oral or intravenous immunosuppressant therapy (other than inhaled steroids) or have an autoimmune disease (e.g., AIDS, SLE; except diabetes);
- Any other factors that researchers consider not suitable for inclusion or completion of this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150086
Bo Yu, MD, PhD, +86 451 8660 5180, yubodr@163.com
MD, PhD
About this study
Official title: Automated Plaque Characterization and Functional Analysis of Coronary CTA Based on OCT Images Using Artificial Intelligence
This trial is a single-center, prospective, observational clinical study. All patients who have at least one coronary artery stenosis of 30%-90% in diameter ≥ 2mm confirmed by CCTA, and who are scheduled to undergo clinically indicated invasive coronary angiography (ICA) and optical coherence tomography (OCT) evaluation and/or treatment will be eligible for enrollment. We proposed a novel approach that integrates CCTA, ICA and OCT images to automatically measure plaque characterization and calculate CT-FFR using computational fluid dynamics (CFD) simulation and artificial intelligence deep learning.
Read the detailed description
Acute coronary syndrome (ACS) is one of the leading causes of coronary artery disease (CAD) death worldwide. Vulnerable plaque rupture is a primary underlying cause of luminal thrombosis responsible for provoking ACS. Therefore, identifying high-risk plaques before ACS occurs has been a major research goal and requires further clinical perspectives. Coronary computed tomography angiography (CCTA) is a comprehensive, non-invasive and cost-effective imaging assessment approach, which can provide the ability to identify the characteristics and morphology of high-risk atherosclerotic plaques associated with ACS. Optical coherence tomography (OCT) is a new, light-based, intravascular imaging technique that provides high-resolution, cross-sectional images of coronary artery anatomy. Due to its superior resolution, OCT is more accurate in measuring the sites of plaque vulnerability, distinguishing the differences in its composition, informing about the anatomic severity of epicardial stenoses, and also provides input for computational models to assess functional severity.
The objectives of the study are: (1) To construct an artificial intelligence model for identifying coronary plaque components on CTA images using OCT as the reference standard. (2) To conduct fluid mechanics simulation including blood vessel wall and plaque by using geometric and physiological models of blood vessels and plaques, and to provide more accurate functional parameters (CT-FFR).
The enrollment criteria will be (1) Patients who presented with stable angina pectoris or acute coronary syndrome; (2) patients who meet the indications for coronary CT angiography, percutaneous coronary angiography and intravascular imaging; (3) Among those patients, patients who have at least one coronary artery stenosis of 30% - 90% in diameter ≥ 2mm confirmed by CCTA.
Data collected will include CCTA, full angiographic, and OCT images. Combined with CTA/ICA/OCT images of multiple modalities, this study will develop a novel images analysis technology to automatically extract vascular lumen, plaque characterization, fluid-solid mechanical properties, and myocardial ischemia conditions using computational fluid dynamics (CFD) simulation and artificial intelligence deep learning.
- Conditions
- Coronary Artery Disease Acute Coronary Syndrome Myocardial Ischemia Plaque Characterization
- Being tested
- CCTA CT-FR CAG OCT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CCTA CT-FR CAG OCTDevice
Per the protocol, patients will have a CCTA (coronary computed tomography angiography), CT-FFR (fractional flow reserve derived from CTA), ICA (invasive coronary angiography), OCT (optical coherence tomography).
What is being measured
The primary outcome is the main question the study is designed to answer.
By taking OCT results as the standard, evaluating the accuracy of automated plaque characterization and functional significance of coronary stenosis using CTA images computation.
By taking OCT results as the standard, evaluating the accuracy of automated plaque characterization and functional significance of coronary stenosis using CTA images computation.
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 posted1 Mar 2023
- Study start12 Apr 2021
- Primary completion1 Sep 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Disease Acute Coronary Syndrome Myocardial Ischemia Plaque CharacterizationStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harbin Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu Bo, Harbin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05750082
- Sponsor's protocol ID
- KY2021-003
- Status last verified
- Apr 2023
- First submitted
- 8 Nov 2022
- Last updated
- 19 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automated Plaque Characterization and Functional Analysis of Coronary CTA Based on OCT Images Using Artificial Intelligence
- ClinicalTrials.gov ID
- NCT05750082
- Acronym / sponsor ID
- KY2021-003
- Conditions
- Coronary Artery Disease Acute Coronary Syndrome Myocardial Ischemia Plaque Characterization
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Harbin Medical UniversityUniversity, hospital or other
- Study start
- 12 Apr 2021 (actual)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 1 Mar 2023 (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 a single-center, prospective, observational clinical study. All patients who have at least one coronary artery stenosis of 30%-90% in diameter ≥ 2mm confirmed by CCTA, and who are scheduled to undergo clinically indicated invasive coronary angiography (ICA) and optical coherence tomography (OCT) evaluation and/or treatment will be eligible for enrollment. We proposed a novel approach that integrates CCTA, ICA and OCT images to automatically measure plaque characterization and calculate CT-FFR using computational fluid dynamics (CFD) simulation and artificial intelligence deep learning.
Detailed description
Acute coronary syndrome (ACS) is one of the leading causes of coronary artery disease (CAD) death worldwide. Vulnerable plaque rupture is a primary underlying cause of luminal thrombosis responsible for provoking ACS. Therefore, identifying high-risk plaques before ACS occurs has been a major research goal and requires further clinical perspectives. Coronary computed tomography angiography (CCTA) is a comprehensive, non-invasive and cost-effective imaging assessment approach, which can provide the ability to identify the characteristics and morphology of high-risk atherosclerotic plaques associated with ACS. Optical coherence tomography (OCT) is a new, light-based, intravascular imaging technique that provides high-resolution, cross-sectional images of coronary artery anatomy. Due to its superior resolution, OCT is more accurate in measuring the sites of plaque vulnerability, distinguishing the differences in its composition, informing about the anatomic severity of epicardial stenoses, and also provides input for computational models to assess functional severity.
The objectives of the study are: (1) To construct an artificial intelligence model for identifying coronary plaque components on CTA images using OCT as the reference standard. (2) To conduct fluid mechanics simulation including blood vessel wall and plaque by using geometric and physiological models of blood vessels and plaques, and to provide more accurate functional parameters (CT-FFR).
The enrollment criteria will be (1) Patients who presented with stable angina pectoris or acute coronary syndrome; (2) patients who meet the indications for coronary CT angiography, percutaneous coronary angiography and intravascular imaging; (3) Among those patients, patients who have at least one coronary artery stenosis of 30% - 90% in diameter ≥ 2mm confirmed by CCTA.
Data collected will include CCTA, full angiographic, and OCT images. Combined with CTA/ICA/OCT images of multiple modalities, this study will develop a novel images analysis technology to automatically extract vascular lumen, plaque characterization, fluid-solid mechanical properties, and myocardial ischemia conditions using computational fluid dynamics (CFD) simulation and artificial intelligence deep learning.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population comprised 100 stable patients with angina pectoris or acute coronary syndrome who will receive CCTA, CT-FFR, ICA, and OCT.
Key inclusion criteria (4 listed)
- Age ≥18 years and able to understand the purpose of the study and sign the informed consent;
- Patients who presented with stable angina pectoris or acute coronary syndrome;
- Patients who meet the indications for coronary CT angiography, percutaneous coronary angiography and intravascular imaging;
- Among those patients, patients who have at least one coronary artery stenosis of 30% - 90% in diameter ≥ 2mm confirmed by CCTA.
Key exclusion criteria (8 listed)
- Known pregnancy or breastfeeding at the time of enrollment;
- Hemodynamic instability;
- Allergy to contrast media or aspirin, adenosine etc.;
- History of stroke or transient ischemic attack (TIA) within 12 months before surgery;
- Known renal insufficiency (e.g. serum creatinine >2.0mg/dL, or creatinine clearance ≤30 mL/min), or need for dialysis, or acute kidney failure (as per physician judgment);
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 |
|---|---|---|
| CCTA CT-FR CAG OCTPer the protocol, patients will have a CCTA (coronary computed tomography angiography), CT-FFR (fractional flow reserve derived from CTA), ICA (invasive coronary angiography), OCT (optical coherence tomography). | Device | – |
Primary outcome
By taking OCT results as the standard, evaluating the accuracy of automated plaque characterization and functional significance of coronary stenosis using CTA images computation.
Time frame: Immediately after OCT scan
By taking OCT results as the standard, evaluating the accuracy of automated plaque characterization and functional significance of coronary stenosis using CTA images computation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2023.
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?
An observational study of Coronary Artery Disease Acute Coronary Syndrome Myocardial Ischemia Plaque Characterization, run by Harbin 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 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 19 Apr 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bo Yu (0451-86605180, yubodr@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
By taking OCT results as the standard, evaluating the accuracy of automated plaque characterization and functional significance of coronary stenosis using CTA images computation. (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 19 Apr 2023.