Residual Inflammation and Plaque Progression Long-term Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 68Ga-DOTATATE PET vs. plaque progression
研究概览
简要总结
Inflammation drives atherosclerotic plaque rupture triggering most acute coronary syndromes. Despite advances in diagnosis and management of atherosclerosis, patients with myocardial infarction (MI) remain at increased risk of recurrent events. The RIPPLE study aims to examine the relationship between residual coronary inflammation detected by 68Ga-DOTATATE PET in patients treated for MI to long-term plaque progression measured by CT coronary angiography (CTCA). The association between infarct-related myocardial 68Ga-DOTATATE PET and myocardial function and viability will also be assessed.
详细描述
While vascular inflammation can be detected using 18F-FDG PET, this method lacks inflammatory cell specificity and is unreliable for coronary imaging because of high background signals from the myocardium. Upregulation of somatostatin receptor subtype-2 (SST2) occurs in activated macrophages, offering a novel inflammation imaging target. 68Ga-DOTATATE, an SST2 PET tracer with low myocardial binding, shows promise for imaging coronary inflammation. Having previously demonstrated increased 68Ga-DOTATATE signals in coronary atherosclerotic lesions post-MI, we now aim to study the natural history of residual arterial inflammation in non-culprit arteries and better understand how 68Ga-DOTATATE signals relate to plaque morphology, progression and rupture. Residual infarct-related myocardial inflammation and its association with ischemic myocardial remodelling will also be examined.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female participants >18 years old
- •Able to give written, informed consent and to lie flat
- •First-presentation of myocardial infarction within ~2 weeks
- •At least mild non-culprit coronary artery disease on angiography, managed medically
排除标准
- •Women of child bearing potential not using adequate contraception
- •Contrast allergy or contrast-nephropathy
- •Uncontrolled atrial fibrillation
- •Chronic kidney disease (eGFR <30 mL/min/1.73 m2)
- •Any medical condition, in the opinion of the investigator, that prevents the participant from lying flat during scanning, or from participating in the study
- •Uncontrolled chronic inflammatory disorder
- •History of recent malignancy deemed relevant to the study by the investigator
- •Current use of systemic corticosteroids
- •Previous coronary artery bypass grafting surgery (CABG) or percutaneous coronary intervention (PCI) before the index event
- •Contraindication to coronary angiography
- •Requires CABG or staged non-culprit artery PCI
结局指标
主要结局
68Ga-DOTATATE PET vs. plaque progression
时间窗: 2 years
Comparison of non-culprit coronary artery 68Ga-DOTATATE tissue-to-blood ratio at 12 weeks post-MI in patients with plaque progression (changes in low attenuation plaque volume and total atheroma volume) after 2 years measured by CTCA versus those without
次要结局
- 68Ga-DOTATATE PET vs. CTCA-defined plaque morphology(2 years)
- 68Ga-DOTATATE PET vs. intravascular imaging(Baseline)
- 68Ga-DOTATATE PET vs. hsCRP(2 years)
- 68Ga-DOTATATE PET vs left ventricular myocardial function(1 year)
- 68Ga-DOTATATE PET vs myocardial tissue characterization(1 year)
研究者
Jason Tarkin
Wellcome Clinical Research Career Development Fellow & Clinical Lecturer
University of Cambridge