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一项前瞻性、多中心、随机对照试验，旨在探讨冠状动脉CT血管造影在理解和处理冠状动脉钙化中的价值（OPTIMAL试验）

2026年10月29日 更新者：Fundación EPIC

一项前瞻性、多中心、随机对照试验，旨在研究冠状动脉CT血管成像在理解和处理冠状动脉钙化中的价值

The OPTIMAL randomized clinical trial has been designed to compare two imaging strategies and to test the hypothesis that a calcium modification strategy informed by coronary CT angiography (CCTA) will improve procedural efficiency and effectiveness compared with the current standard of care (IVUS-guided PCI) while achieving similar clinical outcomes in patients with hemodynamically significant calcified coronary artery disease.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

The OPTIMAL Trial is a prospective, multicenter, randomized controlled study evaluating whether a coronary CT angiography (CCTA)-guided calcium modification strategy can improve the treatment of patients with hemodynamically significant, calcified coronary artery disease undergoing percutaneous coronary intervention (PCI).

Seven hundred patients with flow-limiting stenosis (FFRCT ≤0.80) and moderate-to-severe calcification on CCTA will be randomized 1:1 to either CCTA-guided or intravascular ultrasound (IVUS)-guided calcium modification. The study includes two co-primary endpoints: (1) superiority in final minimal stent area assessed by IVUS, and (2) non-inferiority in 12-month target vessel failure (cardiac death, target-vessel myocardial infarction, or ischemia-driven revascularization).

CCTA-guided strategy uses advanced calcium characterization to inform pre-procedural planning and selection of plaque modification techniques. IVUS-guided strategy follows contemporary intravascular imaging-based criteria for plaque preparation and PCI optimization.

The trial aims to determine whether leveraging non-invasive CT-based calcium assessment can enhance procedural efficiency and stent results while maintaining clinical safety comparable to IVUS-guided PCI.

研究类型

介入性

注册 (估计的)

700

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名：CAROLINA FOCELLA
  • 电话号码：001 917 753 6695
  • 邮箱：cfocella@crf.org

研究联系人备份

学习地点

  • 比利时
      • Aalst、比利时、9300
        • 招聘中
        • Azorg Hospital, Aalst
  • 美国
    • Massachusetts
      • Boston、Massachusetts、美国、02115
        • 尚未招聘
        • Bringham and Women's Hospital
    • Minnesota
      • Minneapolis、Minnesota、美国、55407
        • 招聘中
        • Minneapolis Heart Institute
    • New Jersey
      • Jersey City、New Jersey、美国、08837
        • 尚未招聘
        • HACKENSACK MERIDIAN HEALTH, Inc
    • New York
      • New York、New York、美国、10032
        • 招聘中
        • Columbia University Irving Medical Center/NewYork-Presbyterian Hospital
      • New York、New York、美国、14853
        • 尚未招聘
        • Weill Medical College of Cornell University
  • 英国
      • Leicester、英国
        • 招聘中
        • University Hospitals of Leicester NHS Trust
      • London、英国
        • 招聘中
        • St Bartholomew's Hospital (Barts Health NHS Trust)
      • London、英国
        • 招聘中
        • St George's University Hospitals NHS Foundations Trust
        • 接触：
          • James Spratt, MD, PhD
      • London、英国
        • 招聘中
        • Guys & St Thomas Nhs Foundation Trust
      • Newcastle、英国
        • 尚未招聘
        • Newcastle Hospitals NHS Foundations Trust
      • Oxford、英国
        • 尚未招聘
        • John Radcliffe Hospital, Oxford
  • 西班牙
      • Barcelona、西班牙、08035
        • 招聘中
        • Hospital Universitari Vall Hebron
      • León、西班牙
        • 招聘中
        • Hospital Universitario de Leon
      • Madrid、西班牙、28046
        • 招聘中
        • Hospital Universitario La Paz

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 85年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • The subject must be at least 18 years of age and younger than 85 years old
  • Subject must have evidence of myocardial ischemia (e.g., stable angina, silent ischemia (ischemia in the absence of chest pain or other anginal equivalents), unstable angina, or acute myocardial infarction) suitable for PCI. Patients with a clinical indication for revascularization presenting with stable coronary artery disease or stabilized acute coronary syndrome defined as follows unstable angina (Braunwald class IB, IC, IIB, IIC, IIIB, IIIC), patients with NSTEMI without high-risk features such as recurrence of chest pain, ST-segment depression>1mm in ≥6 leads plus STsegment elevation in aVR, life-threatening arrhythmias, mechanical complications of MI, resuscitated cardiac arrest, GRACE risk score>140.
  • All target vessels must have reference vessel diameter (visually assessed by CCTA) ≥ 2.5 mm
  • Subject must provide written informed consent before any study-related procedure

Exclusion Criteria:

  • STEMI as the clinical presentation.
  • Uncontrolled or recurrent ventricular tachycardia.
  • Hemodynamic instability.
  • Hemodialysis or peritoneal dialysis.
  • Left main coronary artery stenosis > 50%
  • Atrial fibrillation, flutter, or arrhythmias during CT acquisition.
  • Previous PCI in the target vessel or CABG.
  • BMI ≥ 40 kg/m2
  • Insufficient CT quality assessed by the Core lab.
  • Comorbidity with life expectancy ≤ 2 years.
  • Planned major cardiac or non-cardiac surgery within 24 months after the index procedure Note: Major surgery is any invasive operative procedure in which an extensive resection is performed, e.g., a body cavity is entered, organs are removed, or normal anatomy is altered. Note: Minor surgery is an operation on the superficial structures of the body or a manipulative procedure that does not involve a serious risk. Planned minor surgery is not excluded.
  • The subject has received a solid organ transplant that is functioning or is active on a waiting list for any solid organ transplants with expected transplantation within 24 months.
  • The subject receives immunosuppressant therapy or has known immunosuppressive or severe autoimmune disease that requires chronic immunosuppressive therapy (e.g., human immunodeficiency virus, systemic lupus erythematosus, etc.). Note: corticosteroids are not included as immunosuppressant therapy.
  • The subject has previously received or is scheduled to receive radiotherapy to a coronary artery (vascular brachytherapy) or the chest/mediastinum.
  • Subject has a platelet count <100,000 cells/mm3 or >700,000 cells/mm3.
  • The subject has a documented or suspected hepatic disorder as defined as cirrhosis or Child-Pugh ≥ Class B.
  • The subject has a history of bleeding diathesis or coagulopathy or has had a significant gastro-intestinal or significant urinary bleed within the past six months. The subject has had a cerebrovascular accident or transient ischemic neurological attack (TIA) within the past six months, or any prior intracranial bleed, or any permanent neurologic defect, or any known intracranial pathology (e.g., aneurysm, arteriovenous malformation, etc. The subject has a life expectancy <2 years for any non-cardiac cause.
  • Subject is currently participating in another investigational drug or device clinical study.
  • Pregnant or nursing subjects and those who plan pregnancy in the period up to 2 years following index procedure. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test.
  • Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
  • Unable to provide written informed consent (IC).

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：CT-guide calcium modification strategy

Pre-procedural CT will be used to determine lesion characteristics.
设备：CT(Computed Tomography) guided Percutaneous Coronary Intervention

CT will be used to determine lesion characteristics and post-procedural IVUS to confirm correct implantation of stent
有源比较器：IVUS-guide calcium modification strategy

Pre-procedural IVUS will be used to determine lesion characteristics.
设备：IVUS (Intravascular Ultrasound) guided Percutaneous Coronary Intervention

IVUS will be used to determine lesion characteristics and post-procedural IVUS to confirm correct implantation of stent

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Demonstrate that CT-guided calcium modification results in a superior final MSA Minimal Stent Area (MSA) - Imaging Endpoint (Superiority)
大体时间：Perioperative/Periprocedural

Final post-PCI minimal stent area per target lesion, measured by independent core laboratory using intravascular ultrasound (IVUS). Assesses whether CT-guided calcium modification results in superior stent expansion compared with IVUS-guided PCI.
Perioperative/Periprocedural
Target Vessel Failure (TVF) - Clinical Endpoint (Non-Inferiority)
大体时间：12 months

Composite of cardiac death, target-vessel myocardial infarction (TV-MI), or ischemia-driven target vessel revascularization (ID-TVR). TV-MI and ID-TVR are defined according to ARC-2 and the Fourth Universal Definition of MI.
12 months

次要结果测量

结果测量
措施说明
大体时间
Procedural efficiency: Procedure time
大体时间：During PCI

Time from first angiogram to final angiogram
During PCI
Procedural efficiency:Radiation dose-area product
大体时间：During PCI

Dose-area product (DAP) recorded during PCI.
During PCI
Procedural efficiency: Contrast volume
大体时间：During PCI

Total contrast volume (mL) used during PCI.IVUS-Derived Mechanistic Endpoints (Core Lab)
During PCI
Procedural Efficiency: Stent Area on Immediate Post-Stent IVUS
大体时间：Perioperative/Periprocedural

MSA prior to any final IVUS-guided optimization.
Perioperative/Periprocedural
Procedural Efficiency: Final Stent Area at Original Minimal Lumen Area (MLA)
大体时间：Perioperative/Periprocedural

Stent area at the co-registered site of the baseline MLA.
Perioperative/Periprocedural
Procedural Efficiency: Final Stent Area at Site of Maximum Calcium Arc
大体时间：Perioperative/Periprocedural

Stent area measured at the co-registered IVUS site with maximal calcium arc
Perioperative/Periprocedural
Procedural Efficiency: Final Stent Area at Site of Maximum Calcium Density
大体时间：Perioperative/Periprocedural

Stent area measured at the co-registered CT-identified region of greatest Hounsfield Unit (HU) calcium density.
Perioperative/Periprocedural
Procedural Efficiency: Relative Stent Expansion
大体时间：Perioperative/Periprocedural

Percentage expansion calculated as:

MSA ÷ mean distal reference lumen area × 100.
Perioperative/Periprocedural
Procedural Efficiency: Number of Calcium Fractures
大体时间：Post-modification, pre-stent

Fractures identified on intermediary IVUS after calcium modification.
Post-modification, pre-stent
Procedural Efficiency: Change in Plaque Attenuation
大体时间：Post-modification, pre-stent

Change in IVUS plaque characteristics following calcium modification.Angiographic Endpoints
Post-modification, pre-stent
Procedural Efficiency: Final Minimal Lumen Diameter
大体时间：Perioperative/Periprocedural

Minimum lumen diameter by quantitative coronary angiography (QCA)
Perioperative/Periprocedural
Procedural Efficiency: Final Percent Diameter Stenosis
大体时间：Perioperative/Periprocedural

Percent stenosis of treated lesion after PCI, by QCA
Perioperative/Periprocedural
Procedural Efficiency: Final TIMI Flow Grade
大体时间：Perioperative/Periprocedural

Target vessel flow graded 0-3 based on TIMI criteria. Thrombolysis In Myocardial Infarction (TIMI) Flow Grade is a 0-3 angiographic scale used during coronary angiography to describe how well blood is flowing through a coronary artery.TIMI 0 No perfusion, TIMI 1 Penetration without perfusion, TIMI 2 Partial perfusion TIMI 3 Complete perfusion (normal flow)
Perioperative/Periprocedural
Procedural Efficiency: Angiographic Complications
大体时间：Day of procedure

According to Coronary dissection (NHLBI classification)
Day of procedure
Procedural Efficiency: Angiographic Complications
大体时间：Day of procedure

According to Coronary perforation (Ellis classification)
Day of procedure
Procedural Efficiency: Angiographic Complications
大体时间：Day of procedure

Slow-flow / no-reflow
Day of procedure
Procedural Efficiency: Angiographic Complications
大体时间：Day of procedure

Side branch closure (TIMI 0-1)
Day of procedure
Clinical & Safety Outcomes: Procedural Success
大体时间：Perioperative/Periprocedural

Final stenosis <30%, TIMI 3 flow, no angiographic complications, and no in-hospital major adverse cardiac events (MACE).
Perioperative/Periprocedural
Clinical & Safety Outcomes: Periprocedural Myocardial Infarction (Type 4a MI)
大体时间：Day 0-1

Defined by ARC-2 and 4th Universal Definition of MI (troponin criteria + evidence of ischemia).
Day 0-1
Clinical & Safety Outcomes: Stent Thrombosis
大体时间：Up to 12 months

Definite or probable stent thrombosis according to ARC-2 definitions.
Up to 12 months
Patient-Reported Outcomes: Residual Angina (SAQ-7 Angina Frequency)
大体时间：12 months

Residual angina defined as SAQ-7 Angina Frequency score <100. Angina frequency represent how often a patient has had angina (chest pain/discomfort) over a recent recall period. Reported as a 0 to 100 scale: 100 = no angina; 0 = angina occurring very frequently
12 months
Patient-Reported Outcomes: Change in Angina (SAQ-7)
大体时间：Baseline to 12 months

Change in angina frequency domain score; positive values indicate improvement. Angina frequency represent how often a patient has had angina (chest pain/discomfort) over a recent recall period. Reported as a 0 to 100 scale: 100 = no angina; 0 = angina occurring very frequently
Baseline to 12 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Fundación EPIC

合作者

St George's University Hospitals NHS Foundation Trust
Cardiovascular Research Foundation, New York

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年12月22日

初级完成 (估计的)

2029年12月15日

研究完成 (估计的)

2030年1月1日

研究注册日期

首次提交

2025年11月28日

首先提交符合 QC 标准的

2025年12月12日

首次发布 (实际的)

2025年12月16日

研究记录更新

最后更新发布 (实际的)

2026年10月30日

上次提交的符合 QC 标准的更新

2026年10月29日

最后验证

2026年10月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • EPIC46-THE OPTIMAL TRIAL

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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