68Ga-NODAGA-RGD Cardiac PET in Patients With Acute Myocardial Infarction or Chronic Total Coronary Occlusion
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 5
- 主要终点
- Myocardial uptake of 68Ga-NODAGA-RGD after acute myocardial infarction
研究概览
简要总结
Background: In patients with coronary artery disease, acute or chronic coronary artery occlusion is associated with various degrees of ischemic myocardial injury and left ventricle dysfunction. The integrin αVβ3 plays a role in angiogenesis, i.e. formation of new capillaries from pre-existing blood vessels that is increased during repair of ischemic myocardial injury. 68Ga-NODAGA-RGD is a radiopharmaceutical for positron emission tomography (PET) imaging of αVβ3 integrin expression.
Aim: This study aims at evaluating the feasibility of imaging myocardial αVβ3 integrin expression using 68-Ga-NODAGA-RGD PET and whether 68Ga-NODAGA-RGD uptake is associated with myocardial contractile function in patients with an acute or chronic coronary artery occlusion.
Study design: An academic, prospective, open-label study in 60 patients with an acute or chronic coronary occlusion.
Study population: 30 patients with an ST-elevation acute myocardial infarction weeks and left ventricular ejection fraction <50%. 30 patients with planned percutaneous re-opening of a chronic coronary total occlusion and left ventricular ejection fraction <50%.
Study procedures: Patients will undergo cardiac 68Ga-NODAGA-RGD PET within 3 to 14 days after an ST-elevation acute myocardial infarction or within 4 weeks before and 2 weeks after planned percutaneous re-opening of chronic coronary total occlusion. Myocardial perfusion reserve will be evaluated in patients with chronic total occlusion by PET. Echocardiography will be performed at the time of PET imaging and repeated 6 months later to evaluate global and regional left ventricle contractile function. Data on relevant cardiovascular clinical history and blood sample will be obtained at imaging visits. Cardiac events will be evaluated after two years.
End-points: Primary: Myocardial uptake of 68-Ga-NODAGA-RGD after an acute myocardial infarction or before and after opening of chronic coronary occlusion. Secondary: Global and regional left ventricle systolic function. Blood biomarkers of myocardial injury and heart failure. Myocardial perfusion reserve. Adverse cardiac events including death, myocardial infarction, unstable angina pectoris, repeat revascularization and heart failure hospitalizations.
详细描述
Background: In patients with coronary artery disease, acute or chronic coronary artery occlusion is associated with various degrees of ischemic myocardial injury and left ventricle dysfunction. The integrin αVβ3 plays a role in angiogenesis (Brooks 1994), i.e. formation of new capillaries from pre-existing blood vessels that is increased during repair of ischemic myocardial injury (Meoli 2004, Higuchi 2008, Sherif 2012, Sun 2003, Jenkins 2017). 68Ga-NODAGA-RGD is a radiopharmaceutical for positron emission tomography (PET) imaging of αVβ3 integrin expression (Grönman 2017, Buchegger 2011, Pohle 2012, Gnesin 2017).
Aim: This study aims at evaluating the feasibility of imaging myocardial αVβ3 integrin expression using 68-Ga-NODAGA-RGD PET and whether 68Ga-NODAGA-RGD uptake is associated with myocardial contractile function in patients with an acute or chronic coronary artery occlusion.
Study design: An investigator-initiated, prospective, open-label study in 60 patients with an acute or chronic coronary occlusion.
Study population: 30 patients with an ST-elevation acute myocardial infarction weeks and left ventricular ejection fraction <50%. 30 patients with planned percutaneous re-opening of a chronic coronary total occlusion and left ventricular ejection fraction <50%.
Study procedures: Patients will undergo cardiac 68Ga-NODAGA-RGD PET within 3 to 14 days after an ST-elevation acute myocardial infarction or within 4 weeks before and 2 weeks after planned percutaneous re-opening of chronic coronary total occlusion. Myocardial perfusion reserve will be evaluated in patients with chronic total occlusion by PET myocardial perfusion imaging. Complete echocardiography will be performed at the time of PET imaging and repeated 6 months later to evaluate global and regional left ventricle contractile function. Data on relevant cardiovascular clinical history and blood sample will be obtained at imaging visits. Cardiac events will be evaluated after two years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- 否
入选标准
- •ST-elevation acute myocardial infarction within 3-14 days
- •Planned elective percutaneous revascularization of angiographically documented coronary chronic total occlusion (CTO)
- •Left ventricular ejection fraction < 50% when hospitalized for index acute myocardial infarction or within 12 months before planned revascularization of coronary CTO
- •Provision of signed and dated informed consent prior to study specific procedures
排除标准
- •Current unstable angina
- •Significant valvular heart disease
- •NYHA IV heart failure symptoms
- •Severe untreated hypertension (>180/110 mmHg)
- •Female not post-menopausal
- •Contraindications for adenosine infusion (in patients with CTO):
- •Severe renal failure (estimated glomerular filtration rate < 30 ml/min)
- •Atrial fibrillation with ventricular response > 110 bpm
- •No acoustic window for left ventricle assessment by echocardiography
- •Previous cardiac surgery
结局指标
主要结局
Myocardial uptake of 68Ga-NODAGA-RGD after acute myocardial infarction
时间窗: 3 to 14 days after acute myocardial infarction
68Ga-NODAGA-RGD uptake in PET images in the myocardial territory supplied by the occluded coronary artery vs. remote myocardium after an acute myocardial infarction
Myocardial uptake of 68Ga-NODAGA-RGD before and after opening of chronic coronary occlusion
时间窗: Within 4 weeks before and 2 weeks after re-opening of a chronic coronary occlusion
Change in 68Ga-NODAGA-RGD uptake in PET images in the myocardial territory supplied by the occluded coronary artery before and after opening of a chronic coronary occlusion
次要结局
- Regional left ventricle systolic function(At the time of 68Ga-NODAGA-RGD PET imaging and after 6 months of follow-up)
- Global left ventricle systolic function(At the time of 68Ga-NODAGA-RGD PET imaging and after 6 months of follow-up)
- Adverse cardiac events(After 2 years of follow-up)
- Blood biomarker of heart failure(At the time of 68Ga-NODAGA-RGD PET imaging and after 6 months of follow-up)
- Blood biomarker of myocardial injury(At the time of 68Ga-NODAGA-RGD PET imaging and after 6 months of follow-up)
- Myocardial perfusion reserve(At the time of 68Ga-NODAGA-RGD PET imaging within 4 weeks before and 2 weeks after re-opening of a chronic coronary occlusion)
研究者
Antti Saraste
MD, PhD
Turku University Hospital