Polyvascular DiseaseNCT06016608
An Imaging Study of Polyvascular Disease
An observational study of Polyvascular Disease, run by Harbin Medical University at 1 site in China.
Trial summary
1. Establish a multimodality imaging database for PVD, improve the one-stop screening process for early PVD based on artificial intelligence, build a full-cycle control information platform, and promote the construction and standardization of a multidisciplinary co-morbidity and co-management diagnosis and treatment… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Polyvascular Disease
- What is being tested?
- Magnetic Resonance Angiography, Ocular OCTA, CT Angiography
- How many people
- 1,100 participants
- Where
- 1 siteChina
- Study dates
- 18 Oct 2023to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Patients with polyvascular disease in the 2nd Affiliated Hospital of Harbin Medical University
Who may be able to join
- Task 1:
- Patients with coronary artery disease (≥50% stenosis in any coronary artery on coronary angiography)
- Age ≥18 years old
- Proposed OCT-IVUS integrated imaging system
- able to provide written informed consent prior to the start of any procedures related to the study.
- Task 2:
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- patients with coronary artery disease (coronary angiography reveals ≥50% degree of stenosis in any coronary artery) and patients with stroke or TIA (confirmed by a neurologist)
- Age ≥ 18 years
- able to provide written informed consent prior to the start of any procedures related to the study.
Who cannot join
- Task 1:
- severely tortuous/calcified coronary arteries with anticipated difficulty in completing the OCT-IVUS integrated imaging system
- uncontrolled congestive heart failure or acute left heart failure;plan
- claustrophobia;
- left main stem occlusion;
- proposed coronary artery bypass grafting (CABG);
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- uncontrolled severe ventricular arrhythmia;
- active bleeding or severe bleeding tendency;
- acute stroke;
- patients with hemodynamic instability or unstable cardiac electrical activity (including shock) ;
- severe renal insufficiency and/or anuria, except in cases where dialysis treatment has been planned;
- contraindications to the application of contrast media;
- patients who are severely uncooperative due to psychiatric or serious systemic illness;
- Patients who, in the opinion of the investigator, are unsuitable for participation in the study.
- Task 2:
- patients who are unable to comply with the follow-up schedule;
- uncontrolled congestive heart failure or acute left heart failure;
- patients with a life expectancy of less than 6 months;
- left main stem occlusion;
- proposed coronary artery bypass grafting (CABG);
- uncontrolled severe ventricular arrhythmia;
- active bleeding or severe bleeding tendency;
- patients with hemodynamic instability or unstable cardiac electrical activity (including shock) ;
- severe renal insufficiency and/or anuria, except in cases where dialysis treatment has been planned;
- contraindications to the application of contrast media;
- patients who are severely uncooperative due to psychiatric or serious systemic illness;
- patients who, in the opinion of the investigator, are not suitable for participation in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150000
Minghao Liu, MD., +8613764166251, baiyuedao@alumni.sjtu.edu.cn
About this study
Official title: Early Screen, Systematic Evaluation and Risk Warning of Polyvascular Disease Based on Multi-modality Imaging
- Establish a multimodality imaging database for PVD, improve the one-stop screening process for early PVD based on artificial intelligence, build a full-cycle control information platform, and promote the construction and standardization of a multidisciplinary co-morbidity and co-management diagnosis and treatment model.
- Based on non-invasive, zero-contrast ocular OCTA combined with one-stop CTA imaging of the heart and brain, construct an integrated "eye-heart-brain" early warning model for PVD, and explore a potential non-invasive and convenient early warning system for PVD.
- Based on the multi-omics, investigate EVs-mediated intercellular communication network, elucidate the roles and regulatory mechanisms of EVs in the development of PVD, search for potential targets for intervention, and construct an artificial intelligence-based "pan-vascular score" risk assessment system based on the combination of multi-modality imaging and multi-omics biomarkers.
- Conditions
- Polyvascular Disease
- Being tested
- Magnetic Resonance Angiography, Ocular OCTA, CT Angiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance Angiography, Ocular OCTA, CT AngiographyDiagnostic test
Magnetic Resonance Angiography of intracranial artery, carotid artery, renal artery and lower extremity artery, CT angiography of coronary artery or intracranial artery
| Study group | Role | What they receive |
|---|---|---|
| Polyvascular disease | Not described Receives: Diagnostic Test: Magnetic Resonance Angiography, Ocular OCTA, CT Angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Task1: MACE
All cause death, stroke, myocardial reinfarction, unplanned revascularization, lower extremity artery disease
Measured: 1 year
Task2: Plaque characteristics
Plaque morphology on OCT
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2023
- Study start18 Oct 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Polyvascular 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
- Prospective
- Enrolment
- 1,100 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
- Investigators
- Haibo Jia, MD. Ph.D, Principal investigator, The Second Affiliated Hospital of Harbin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06016608
- Sponsor's protocol ID
- ChiCTR2300074638
- Status last verified
- Dec 2024
- First submitted
- 22 Aug 2023
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liu M, Ouyang S, Zhang B, Shao S, Fan P, Wu T, Ren H, Sun Q, Zhang D, Wang N, Zhao C, Liu S, Gu X, Li Y, Zhu X, Luo X, Zhang S, Hu S, Mintz GS, Yu B, Jia H. Predicting polyvascular disease with optical coherence tomography angiography and/or optical coherence tomography. BMC Cardiovasc Disord. 2026 Feb 27;26(1):281. doi: 10.1186/s12872-026-05650-x.
PubMed 41761095
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Screen, Systematic Evaluation and Risk Warning of Polyvascular Disease Based on Multi-modality Imaging
- ClinicalTrials.gov ID
- NCT06016608
- Acronym / sponsor ID
- ChiCTR2300074638
- Conditions
- Polyvascular Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,100 participants (estimated)
- Lead sponsor
- Harbin Medical UniversityUniversity, hospital or other
- Study start
- 18 Oct 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 29 Aug 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.
- Establish a multimodality imaging database for PVD, improve the one-stop screening process for early PVD based on artificial intelligence, build a full-cycle control information platform, and promote the construction and standardization of a multidisciplinary co-morbidity and co-management diagnosis and treatment model.
- Based on non-invasive, zero-contrast ocular OCTA combined with one-stop CTA imaging of the heart and brain, construct an integrated "eye-heart-brain" early warning model for PVD, and explore a potential non-invasive and convenient early warning system for PVD.
- Based on the multi-omics, investigate EVs-mediated intercellular communication network, elucidate the roles and regulatory mechanisms of EVs in the development of PVD, search for potential targets for intervention, and construct an artificial intelligence-based "pan-vascular score" risk assessment system based on the combination of multi-modality imaging and multi-omics biomarkers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Polyvascular disease | – | Diagnostic Test: Magnetic Resonance Angiography, Ocular OCTA, CT Angiography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with polyvascular disease in the 2nd Affiliated Hospital of Harbin Medical University
Key inclusion criteria (9 listed)
- Patients with coronary artery disease (≥50% stenosis in any coronary artery on coronary angiography)
- Age ≥18 years old
- Proposed OCT-IVUS integrated imaging system
- able to provide written informed consent prior to the start of any procedures related to the study.
- patients with coronary artery disease (coronary angiography reveals ≥50% degree of stenosis in any coronary artery) and patients with stroke or TIA (confirmed by a neurologist)
Key exclusion criteria (27 listed)
- severely tortuous/calcified coronary arteries with anticipated difficulty in completing the OCT-IVUS integrated imaging system
- uncontrolled congestive heart failure or acute left heart failure;plan
- claustrophobia;
- left main stem occlusion;
- proposed coronary artery bypass grafting (CABG);
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 |
|---|---|---|
| Magnetic Resonance Angiography, Ocular OCTA, CT AngiographyMagnetic Resonance Angiography of intracranial artery, carotid artery, renal artery and lower extremity artery, CT angiography of coronary artery or intracranial artery | Diagnostic test | Polyvascular disease |
Primary outcome
Task1: MACE
Time frame: 1 year
All cause death, stroke, myocardial reinfarction, unplanned revascularization, lower extremity artery disease
Task2: Plaque characteristics
Time frame: 1 year
Plaque morphology on OCT
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Derived from this study: PubMed 41761095Liu M, Ouyang S, Zhang B, Shao S, Fan P, Wu T, Ren H, Sun Q, Zhang D, Wang N, Zhao C, Liu S, Gu X, Li Y, Zhu X, Luo X, Zhang S, Hu S, Mintz GS, Yu B, Jia H. Predicting polyvascular disease with optical coherence tomography angiography and/or optical coherence tomography. BMC Cardiovasc Disord. 2026 Feb 27;26(1):281. doi: 10.1186/s12872-026-05650-x.
- 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.
Haibo Jia, MD. Ph.D principal investigator
The Second Affiliated Hospital of Harbin Medical University
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 Polyvascular Disease, 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 9 inclusion and 27 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: looking for participants now, as of the sponsor's last update on 27 Dec 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Minghao Liu, MD. (+8613764166251, baiyuedao@alumni.sjtu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Task1: MACE (time frame: 1 year). 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?
On the ClinicalTrials.gov record for NCT06016608, which also lists 1 linked publication.
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 27 Dec 2024.