跳至主要内容
临床试验/NCT07130409
NCT07130409招募中不适用

Multimodal Imaging Assessment After Revascularization in Patients With Acute Myocardial Infarction

The Affiliated Hospital of Qingdao University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年8月1日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
20
试验地点
1
主要终点
The myocardial uptake of 18F-Pentixafor was quantified using SUVmax and SUVmean values derived from PET imaging.

研究概览

简要总结

This prospective cohort study will enroll 20 patients clinically diagnosed with first-time acute myocardial infarction (AMI) who underwent interventional procedures (including percutaneous coronary intervention [PCI] and balloon angioplasty) at the Affiliated Hospital of Qingdao University. Patient data, including routine blood and urine tests, blood biochemistry, electrocardiograms (ECG), imaging studies, and interventional procedure records, will be collected to assess eligibility for enrollment. The study procedures include patient screening and enrollment, obtaining informed consent, baseline assessment (including medical history, laboratory tests, ECG, etc.), an ¹⁸F-Pentixafor PET/MR examination, and follow-up. Images will be blindly assessed by at least two specialized physicians from the Radiology and Nuclear Medicine departments. The study aims to investigate the utility of ¹⁸F-Pentixafor PET/MR in evaluating coronary microcirculatory function, cardiac function, myocardial viability, myocardial inflammatory response, and the efficacy of interventional therapy in AMI patients post-procedure. Additionally, it will perform risk stratification and prognostic analysis for the enrolled patients.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with a clinical diagnosis of first-episode acute myocardial infarction (AMI) who underwent emergency percutaneous coronary intervention (PCI) were included. All patients had complete baseline clinical data, with baseline cardiac magnetic resonance (CMR) examinations performed within 7 days post-PCI and follow-up CMR completed at 6 months post-procedure.

排除标准

  • Patients with severe cardiac decompensation (Killip class 4) or clinically unstable conditions.
  • Patients with coexisting valvular heart disease, congenital heart disease, pulmonary hypertension, cardiomyopathy, or persistent atrial fibrillation that may confound cardiac structural/functional assessments.
  • Prior history of myocardial infarction, coronary revascularization (PCI/CABG).
  • Concurrent severe systemic diseases including hematologic disorders, malignancies, rheumatic/autoimmune diseases, or severe hepatic/renal failure.
  • Contraindications to CMR (claustrophobia, pacemaker implantation, etc.).
  • Pregnant, breastfeeding, or women of childbearing potential without effective contraception.
  • Sexually active individuals of reproductive age unwilling to use reliable contraception.

结局指标

主要结局

The myocardial uptake of 18F-Pentixafor was quantified using SUVmax and SUVmean values derived from PET imaging.

时间窗: At baseline (within 1 week of enrollment)

Left ventricular ejection fraction (LVEF) assessed by cardiac MRI to evaluate left ventricular function

时间窗: At baseline (within 1 week of enrollment)

Infarct Characterization

时间窗: At baseline (within 1 week of enrollment)

Late gadolinium enhancement (LGE) images were used to calculate infarct size (IS).

次要结局

  • Myocardial T1 Values and Extracellular Volume (ECV)(At baseline (within 1 week of enrollment))
  • Myocardial T2 values(At baseline (within 1 week of enrollment))
  • Myocardial Strain Analysis(At baseline (within 1 week of enrollment))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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