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Coronary Arterial Disease (CAD)PlaqueVisionNCT06681155

Identification Of High-risk Coronary Plaques By Multimodal Intravascular Imaging

An observational study of Coronary Arterial Disease (CAD) and Acute Coronary Syndromes, run by Chinese PLA General Hospital at 11 sites in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This study is a multicenter prospective observational clinical study, which will be conducted in 11 hospitals, and approximately 500 subjects will be enrolled. Plaque morphology and stability of non-culprit lesions were assessed by intravascular ultrasound (IVUS) and optical coherence tomography-near-infrared… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Assessment of plaque morphology, structure, and stability in non-culprit lesions
How many people
500 participants
Where
11 sitesChina
Study dates
Nov 2024to Dec 2031
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 Acute Coronary Syndrome (ACS) who are planned for coronary angiography and interventional treatment. ACS includes acute ST-segment elevation myocardial infarction, acute non-ST-segment elevation myocardial infarction, and unstable angina.

Who may be able to join

  • Aged ≥18 years at enrollment, male or female;
  • Meets the diagnosis of acute coronary syndrome, including acute myocardial infarction and unstable angina. Acute myocardial infarction includes ST-elevation myocardial infarction (STEMI) and non-ST-elevation myocardial infarction (non-STEMI). STEMI is defined as chest pain lasting at least 30 minutes, arriving at the hospital within 12 hours from the onset of symptoms, changes in the 12-lead ECG (ST-segment elevation >0.1 mV in ≥2 consecutive leads or new left bundle branch block), and elevated cardiac biomarkers (troponin T/I). Non-STEMI is defined as ischemic symptoms without ST-segment elevation on ECG, accompanied by elevated cardiac biomarkers. Unstable angina is defined as chest pain lasting 5-30 minutes at rest, or worsening of exertional angina, and accompanied by one of the following: transient ST-segment depression or elevation; coronary angiography showing luminal narrowing ≥90% or plaque rupture or thrombotic lesions.
  • Planned to undergo coronary angiography and PCI treatment;
  • Hemodynamically stable and able to tolerate repeated intracoronary administration of nitroglycerin;
  • Capable of understanding the requirements of this study, willing to participate in the study, and have signed an informed consent form.
  • Imaging inclusion criteria:
  • Coronary angiography clearly shows that the patient has at least one non-culprit lesion with a visual assessment of diameter stenosis between 40-70%, and the operator believes that interventional treatment intervention is not temporarily necessary;
  • The site of the non-culprit lesion has not previously had a stent implanted.

Who cannot join

  • Cardiogenic shock or hemodynamic instability;
  • History of coronary artery bypass grafting (CABG), or planned CABG;
  • Severe renal impairment (glomerular filtration rate <30ml/min/1.73m²);
  • Life expectancy of less than 2 years;
  • Currently participating in other ongoing investigative device or drug studies that have not yet reached their primary endpoints.
  • Imaging exclusion criteria:
  • The anatomical structure of the non-culprit lesion is not suitable for intravascular imaging catheter imaging (lesions at the left main trunk or right coronary artery ostium, severe calcification, chronic total occlusion, etc.).

Trial locations and contacts

11 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Lei Gao, MD, PHD contact

+86 13661022415 ext. +86

nkgaolei2010@126.com

11 sites in 1 country

China11 sites

  • Beijing Anzhen Hospital, Capital Medical University

    Beijing

    Yong Zeng, PD

  • Beijing Jishuitan Hospital

    Beijing

    Wei Liu, PD

  • Fuwai Hospital, Chinese Academy of Medical Sciences

    Beijing

    Lei Song, PD

  • People's Liberation Army General Hospital

    Beijing

    Yun Dai Chen, PD

  • China-Japan Union Hospital of Jilin University

    Changchun, Jilin

    Yuquan He, PD

  • The Second Affiliated Hospital, Zhejiang University

    Hangzhou, Zhejiang

    Jun Jiang, PD

  • Shenzhen People's Hospital

    Shenzhen, Guandong

    Da Yin, PD

  • People's Hospital of Xinjiang Uygur Autonomous Region

    Ürümqi, Xinjiang Uygur Autonomous Region

  • Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei

    Hesong Zeng, PD

  • Wuhan Asian Heart Hospital

    Wuhan, Hubei

    Hua Yan, PD

  • Xi'an Jiaotong University Second Affiliated Hospital

    Xi'an, Shaanxi

    Jie Deng, PD

Other trials in China

About this study

Official title: A Prospective Cohort Study on the Identification of High-Risk Coronary Plaque by Multimodality Intravascular Imaging(PlaqueVision Study)

This study is a multicenter prospective observational clinical study, which will be conducted in 11 hospitals, and approximately 500 subjects will be enrolled. Plaque morphology and stability of non-culprit lesions were assessed by intravascular ultrasound (IVUS) and optical coherence tomography-near-infrared spectroscopy (OCT) after percutaneous coronary intervention (PCI) in patients with acute coronary syndrome (ACS). Plaques were grouped according to high-risk or non-high-risk. Clinical follow-up was conducted after PCI.

Read the detailed description

Plaque stability is an important criterion for selecting different treatment strategies (interventional and antithrombotic). High-risk plaque characteristics are also considered to be related to the overall incidence of Major Adverse Cardiovascular Events (MACE). Single-modality intravascular imaging has inherent disadvantages in identifying atherosclerotic plaques, while the combination of IVUS, OCT, and NIRS enables multimodal intravascular imaging techniques to complement each other in obtaining plaque information. There is currently a lack of research on the prognostic benefits of multimodal intravascular imaging in assessing atherosclerotic plaques. This study is a multicenter, prospective, observational clinical study that will be conducted at 11 hospitals, enrolling approximately 500 subjects. It will use intravascular ultrasound (IVUS) and optical coherence tomography-near-infrared spectroscopy (OCT) to assess the morphology and stability of non-culprit lesions in patients with acute coronary syndrome (ACS) after percutaneous coronary intervention (PCI), and will follow up at 1 month, 1 year, 2 years, and 5 years post-surgery. The aim is to compare the clinical outcomes between high-risk and non-high-risk patients, as well as between high-risk and non-high-risk plaques defined by multimodal intravascular imaging, and to explore the predictive value of high-risk plaque characteristics shown by multimodal intravascular imaging for adverse cardiovascular events in patients with ACS.

Being tested
Assessment of plaque morphology, structure, and stability in non-culprit lesions
Medical subject headings
Acute Coronary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Assessment of plaque morphology, structure, and stability in non-culprit lesionsDiagnostic test

    Assessment of plaque morphology, structure, and stability in non-culprit lesions based on intravascular ultrasound and optical coherence tomography-near-infrared spectroscopy imaging technology.

Study groups in NCT06681155
Study groupRoleWhat they receive
High-risk Plaque GroupMultimodal intravascular imaging technology is used to assess the morphological structure and stability of non-criminal lesions in plaques, categorized into high-risk and non-high-risk groups. High-risk plaques are defined as those that meet any of the following criteria: ① IVUS minimum lumen area <4.0mm² or OCT minimum lumen area <3.5mm², ② plaque burden >70%, ③ presence of thin-cap fibroatheroma, ④ NIRS detects lipid-rich plaques with LRP MaxLCBI4mm >315, and are considered high-risk if they have at least two of the above four characteristics. A patient is placed in the high-risk group if they have at least one high-risk plaque.
Receives: Diagnostic Test: Assessment of plaque morphology, structure, and stability in non-culprit lesions
Non-high-risk Plaque GroupMultimodal intravascular imaging technology is used to assess the morphological structure and stability of non-criminal lesions in plaques, categorized into high-risk and non-high-risk groups. High-risk plaques are defined as those that meet any of the following criteria: ① IVUS minimum lumen area <4.0mm² or OCT minimum lumen area <3.5mm², ② plaque burden >70%, ③ presence of thin-cap fibroatheroma, ④ NIRS detects lipid-rich plaques with LRP MaxLCBI4mm >315, and are considered high-risk if they have at least two of the above four characteristics. If they have no high-risk plaques, they are placed in the non-high-risk group.
Receives: Diagnostic Test: Assessment of plaque morphology, structure, and stability in non-culprit lesions

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total MACE at 2 years

    The total MACE (Major Adverse Cardiovascular Events) at 2 years post-surgery, including both culprit lesions and non-culprit lesions, is defined as a composite endpoint consisting of death, non-fatal myocardial infarction, and unplanned revascularization.

    Measured: 1 month,1year,2 years

Secondary outcomes (7)

  1. CL-MACE at 2 years post-PCI; NCL-MACE at 2 years post-PCI

    The CL-MACE at 2 years post-PCI and NCL-MACE at 2 years post-PCI， including both culprit lesions and non-culprit lesions, is defined as a composite endpoint consisting of death, non-fatal myocardial infarction, and unplanned revascularization.

    Measured: 1 month,1year,2 years

  2. Major Adverse Cardiovascular Events

    MACE includes recurrent angina, acute myocardial infarction, severe arrhythmias, heart failure, coronary death, and so on.

    Measured: 1 month,1year,2 years,5 years

  3. Death

    Death includes all-cause mortality, cardiovascular mortality, non-cardiovascular mortality, and deaths of unknown causes.

    Measured: 1 month,1year,2 years,5 years

  4. Non-fatal Myocardial Infarction

    Non-fatal Myocardial Infarction (NBMI) refers to an event where the heart muscle suffers severe ischemia and necrosis due to the acute occlusion of the coronary artery, but does not result in the patient's death. This type of heart attack is usually accompanied by changes on the electrocardiogram (ECG) and elevated cardiac biomarkers (such as troponin), but without significant elevation of the ST segment, which distinguishes it from ST-segment elevation myocardial infarction (STEMI).

    Measured: 1 month,1year,2 years,5 years

  5. Unplanned Revascularization

    Unplanned revascularization is defined as revascularization performed outside the scope of the initial standard treatment for PCI, or staged revascularization that occurs more than 60 days (or the number of days planned by the surgeon) after the first PCI. Unplanned revascularization refers to PCI or CABG driven by persistent ischemic symptoms.

    Measured: 1 month,1year,2 years,5 years

  6. Any Revascularization

    Any revascularization includes planned revascularization, unplanned revascularization, target lesion revascularization, ischemia-driven target lesion revascularization, and clinically driven target lesion revascularization.

    Measured: 1 month,1year,2 years,5 years

  7. Stent Thrombosis As Defined by ARC-2

    Stent thrombosis is classified by the time of occurrence into acute thrombosis (occurring within 24 hours after PCI), subacute thrombosis (occurring between 1-30 days after PCI), late thrombosis (occurring between 31 days and 365 days after PCI), or very late thrombosis (occurring more than 365 days after PCI).

    Measured: 1 month,1year,2 years,5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Nov 2024
  2. Study startNov 2024 (estimated)
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2031 (estimated)

Resources

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
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06681155
Sponsor's protocol ID
HZKY-PJ-2024-54
Acronym
PlaqueVision
Status last verified
Nov 2024
First submitted
7 Nov 2024
Last updated
8 Nov 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Mol JQ, Volleberg RHJA, Belkacemi A, Hermanides RS, Meuwissen M, Protopopov AV, Laanmets P, Krestyaninov OV, Dennert R, Oemrawsingh RM, van Kuijk JP, Arkenbout K, van der Heijden DJ, Rasoul S, Lipsic E, Rodwell L, Camaro C, Damman P, Roleder T, Kedhi E, van Leeuwen MAH, van Geuns RM, van Royen N. Fractional Flow Reserve-Negative High-Risk Plaques and Clinical Outcomes After Myocardial Infarction. JAMA Cardiol. 2023 Nov 1;8(11):1013-1021. doi: 10.1001/jamacardio.2023.2910.

    PubMed 37703036

  • Erlinge D, Maehara A, Ben-Yehuda O, Botker HE, Maeng M, Kjoller-Hansen L, Engstrom T, Matsumura M, Crowley A, Dressler O, Mintz GS, Frobert O, Persson J, Wiseth R, Larsen AI, Okkels Jensen L, Nordrehaug JE, Bleie O, Omerovic E, Held C, James SK, Ali ZA, Muller JE, Stone GW; PROSPECT II Investigators. Identification of vulnerable plaques and patients by intracoronary near-infrared spectroscopy and ultrasound (PROSPECT II): a prospective natural history study. Lancet. 2021 Mar 13;397(10278):985-995. doi: 10.1016/S0140-6736(21)00249-X.

    PubMed 33714389

  • Mol JQ, Belkacemi A, Volleberg RH, Meuwissen M, Protopopov AV, Laanmets P, Krestyaninov OV, Dennert R, Oemrawsingh RM, van Kuijk JP, Arkenbout K, van der Heijden DJ, Rasoul S, Lipsic E, Teerenstra S, Camaro C, Damman P, van Leeuwen MA, van Geuns RJ, van Royen N. Identification of anatomic risk factors for acute coronary events by optical coherence tomography in patients with myocardial infarction and residual nonflow limiting lesions: rationale and design of the PECTUS-obs study. BMJ Open. 2021 Jul 7;11(7):e048994. doi: 10.1136/bmjopen-2021-048994.

    PubMed 34233996

  • Aguirre AD, Arbab-Zadeh A, Soeda T, Fuster V, Jang IK. Optical Coherence Tomography of Plaque Vulnerability and Rupture: JACC Focus Seminar Part 1/3. J Am Coll Cardiol. 2021 Sep 21;78(12):1257-1265. doi: 10.1016/j.jacc.2021.06.050.

    PubMed 34531027

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Arterial Disease (CAD) and Acute Coronary Syndromes, run by Chinese PLA General Hospital at 11 sites 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 8 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: opening soon, as of the sponsor's last update on 8 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites 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 Lei Gao, MD, PHD (+86 13661022415 ext. +86, nkgaolei2010@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total MACE at 2 years (time frame: 1 month,1year,2 years). 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 NCT06681155, which also lists 4 linked publications.

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 8 Nov 2024.

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