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临床试验/NCT06113835
NCT06113835招募中不适用

Viable Myocardium Detected by the Combination of Hybrid PET/MR and SPECT Imaging for the Prediction of the Efficacy of PCI in Patients With Chronic Total Occlusion.

The First Affiliated Hospital with Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2023年2月22日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
80
试验地点
1
主要终点
left ventricular ejection fraction increased by ≥5%

研究概览

简要总结

CTO intervention is controversial, and viable myocardium is critical to the improvement of cardiac function and prognosis of patients. However, it remains uncertain whether viable myocardium detected by Hybrid PET/MR and SPECT Imaging improves the PCI efficacy in Patients With CTO.

In this investigator-initiated, prospective, single-center, observational trial, patients meeting the inclusion/exclusion criteria would be assigned to the successful group or the unsuccessful group based on the success of PCI, both undergoing pre-operative and 6-month follow-up Hybrid PET/MR and SPECT imaging. The improvement of left ventricular (LV) recovery after 6 months will be observed.

详细描述

Percutaneous coronary intervention (PCI) for chronic total occlusion (CTO) represents a major challenge in interventional cardiology. However, the results of the current large-scale CTO study showed that PCI failed to improve the long-term prognosis (MACE) over medical therapy. Is CTO intervention necessary and how to select appropriate patients for intervention? Previous studies have found the presence and improvement of viable myocardium(VM) in patients with CTO after PCI,and the amount of preoperative VM is critical to the choice of treatment for patients.

Several diagnostic techniques have been introduced to assess myocardial viability and LV recovery, allowing the identification of ischemic myocardium with potentially reversible systolic dysfunction, such as hibernating myocardium, among which 2-deoxy-2-[18F]fluoro-D-glucose positron emission tomography ( 18F-FDG PET) as the "gold standard" for clinical assessment of VM. However, single FDG-PET assessment of VM has limitations and cannot accurately identify hibernating myocardium. 99mTc-Methoxyisobutylisocyanide single-photon emission computed tomography (99mTc-MIBI SPECT), as a validated method for assessing myocardial perfusion, is recommended by guidelines for the assessment of VM in combination with FDG-PET. In recent years, contrast-enhanced cardiac magnetic resonance imaging (cardiac magnetic resonance imaging CMR) has been increasingly used to assess myocardial viability due to its high spatial resolution, which allows the acquisition of cardiac function and myocardial scarring.

However, there are fundamental differences between the two methods in assessing VM and LV function, with LGE-CMR primarily describing an increase in extracellular space associated with scar tissue, whereas FDG-PET uptake represents the true metabolic signals of viable cardiomyocytes. They are complementary.

Hybrid PET/MRI has recently been used as a novel modality for evaluating cardiac diseases, allowing a truly synchronous/simultaneous acquisition of complementary information such as high-resolution anatomy and myocardial metabolism in merged images. However, few studies about PET/MRI were done in patients with CTO.

Our study aims to investigate the effect of CTO-PCI by assessing VM detected by the combination of PET/MR and SPECT and to investigate the predictive value of viable myocardial area on the efficacy of CTO-PCI.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≧ 18 years, < 75 years;
  • complete occlusion of the coronary artery, confirmed by coronary angiography with TIMI flow grade 0, and occlusion for ≥3 months;
  • presence of angina or angina-equivalent symptoms ; undergo coronary intervention;

排除标准

  • life expectancy < 1 year due to non-cardiac disease;
  • contraindications to SPECT/PET/MRI: pregnancy, contrast allergy, claustrophobia, history of pacemaker and ICD implantation, other ferromagnetic materials in the body;
  • acute coronary syndrome within the last 3 months;
  • severe valvular heart disease;
  • haemodynamic instability;
  • hepatic or renal insufficiency, with alanine aminotransferase (ALT) > 3 times the upper limit of normal or glomerular filtration rate ≤ 30 mL/min;
  • two or more CTO lesions;
  • previous myocardial infarction.
  • Others who, in the opinion o f the investigator, should not be enrolled;

结局指标

主要结局

left ventricular ejection fraction increased by ≥5%

时间窗: 6±1 month

PET/MR postoperative follow-up

Segmental ventricular wall motion score decreased by ≥1

时间窗: 6±1 month

PET/MR postoperative follow-up

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Chunjian Li

Director of Cardiology

The First Affiliated Hospital with Nanjing Medical University

研究点 (1)

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