Identification Of High-risk Coronary Plaques By Multimodal Intravascular Imaging

NCT06681155 | Not Yet Recruiting DMC

• 1 other identifier: HZKY-PJ-2024-54
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 11

Brief 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 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.

Conditions

Coronary Arterial Disease (CAD); Acute Coronary Syndromes

Outcome Measures

Primary Outcomes (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.

  1 month,1year,2 years

Secondary Outcomes (7)

• CL-MACE at 2 years post-PCI; NCL-MACE at 2 years post-PCI

  1 month,1year,2 years

• Major Adverse Cardiovascular Events

  1 month,1year,2 years,5 years

• Death

  1 month,1year,2 years,5 years

• Non-fatal Myocardial Infarction

  1 month,1year,2 years,5 years

• Unplanned Revascularization

  1 month,1year,2 years,5 years

Study Arms (2)

High-risk Plaque Group

Multimodal 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.

Diagnostic Test: Assessment of plaque morphology, structure, and stability in non-culprit lesions

Non-high-risk Plaque Group

Multimodal 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.

Diagnostic Test: Assessment of plaque morphology, structure, and stability in non-culprit lesions

Interventions

Assessment of plaque morphology, structure, and stability in non-culprit lesions DIAGNOSTIC_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.

High-risk Plaque Group; Non-high-risk Plaque Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.).

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (11)

Shenzhen People's Hospital

Shenzhen, Guandong, China

Location

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

Wuhan, Hubei, China

Location

Wuhan Asian Heart Hospital

Wuhan, Hubei, China

Location

China-Japan Union Hospital of Jilin University

Changchun, Jilin, China

Location

Xi'an Jiaotong University Second Affiliated Hospital

Xi'an, Shaanxi, China

Location

People's Hospital of Xinjiang Uygur Autonomous Region

Ürümqi, Xinjiang Uygur Autonomous Region, China

Location

The Second Affiliated Hospital, Zhejiang University

Hangzhou, Zhejiang, China

Location

Beijing Anzhen Hospital, Capital Medical University

Beijing, China

Location

Beijing Jishuitan Hospital

Beijing, China

Location

Fuwai Hospital, Chinese Academy of Medical Sciences

Beijing, China

Location

People's Liberation Army General Hospital

Beijing, China

Location

Related Publications (4)

• 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.

  PMID: 37703036 RESULT

• 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.

  PMID: 33714389 RESULT

• 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.

  PMID: 34233996 RESULT

• 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.

  PMID: 34531027 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

blood serum

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Yun Dai Chen, MD, PHD

  People's Liberation Army General Hospital

  STUDY CHAIR

• Yong Zeng, PD

  Beijing Anzhen Hospital

  PRINCIPAL INVESTIGATOR

• Lei Song

  Chinese Academy of Medical Sciences, Fuwai Hospital

  PRINCIPAL INVESTIGATOR

• Jun Jiang, MD

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

• Yuquan He, MD

  China-Japan Union Hospital, Jilin University

  PRINCIPAL INVESTIGATOR

• Wei Liu, MD

  Beijing Jishuitan Hospital

  PRINCIPAL INVESTIGATOR

• Da Yin, MD

  Shenzhen People's Hospital

  PRINCIPAL INVESTIGATOR

• Yining Yang, MD

  People's Hospital of Xinjiang Uygur Autonomous Region

  PRINCIPAL INVESTIGATOR

• Jie Deng, MD

  Xi'an Jiaotong University Second Affiliated Hospital

  PRINCIPAL INVESTIGATOR

• Ning Yang, MD

  Tianjin Chest Hospital

  PRINCIPAL INVESTIGATOR

• Hua Yan

  Wuhan Asian Heart Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lei Gao, MD, PHD

CONTACT

+86 13661022415; nkgaolei2010@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 7, 2024
• First Posted: November 8, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2031
• Last Updated: November 8, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (11)