Neuroinflammation After Myocardial Infarction - Imaging Substudy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- TPSO-PET measurement of neuroinflammation after acute myocardial infarction
研究概览
简要总结
The purpose of the study is to see if positron emission tomography and magnetic resonance imaging (PET/MRI) with an investigational drug called [18F]DPA-714 will show inflammation in the brain after a heart attack. This study may help physicians and researchers better understand the role of brain inflammation in heart disease and develop new treatments to protect the brain.
详细描述
The primary objective of this study is to measure the concentration and the regional brain distribution of activated brain microglia/macrophages using the PET ligand [18F]DPA-714 in individuals with recent AMI. The basic premise is that AMI leads to systemic inflammation that includes inflammation in the brain. The PET tracer [18F]DPA-714 binds to the 18 kDa translocator protein (TSPO, also known as the peripheral benzodiazepine receptor) in the mitochondria of activated microglia/macrophages and provides a non-invasive measure of neuroinflammation. The estimates of brain TSPO binding in patients with recent AMI will be compared to a matched group of patients who have undergone a recent elective PCI procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participation in UAB IRB protocol "Neuroinflammation After Acute Myocardial Infarction" (IRB-300002751, PI Lazar).
- •21 years of age or older
- •. English speaking with at least 8th grade education
- •High or mixed affinity binder for TSPO ligands based on genotyping for single nucleotide polymorphism (SNP) rs
- •Admission to UAB Hospital for ST-elevation acute myocardial infarction (AMI) and treatment with percutaneous coronary intervention (PCI) OR Undergoing elective percutaneous coronary intervention (PCI)
排除标准
- •Contraindication to MRI
- •Serious medical co-morbidity that may interfere with participation
- •Prior myocardial infarction
- •Severe anemia
- •Prior coronary artery bypass grafting
- •Prior angioplasty and/or coronary artery stent placement (PCI group only)
- •History of traumatic head injury defined by a loss of consciousness ≥30 minutes or seizure at the time of injury
- •Diagnosis of major depression
- •Diagnosis of dementia
- •Low affinity binder for TSPO ligands based on genotyping for SNP rs6971.
研究组 & 干预措施
Recent Myocardial Infarction
干预措施: [18F]DPA-714-PET/MRI (Drug)
undergoing elective percutaneous coronary intervention
干预措施: [18F]DPA-714-PET/MRI (Drug)
结局指标
主要结局
TPSO-PET measurement of neuroinflammation after acute myocardial infarction
时间窗: 2 years
The regional brain concentrations of \[F-18\]DPA-714, a PET imaging marker of neuroinflammation, will be compared between study participants who have recently been hospitalized for acute myocardial infarction (AMI) and a control group undergoing elective percutaneous coronary interventions (PCI).
次要结局
未报告次要终点
研究者
Jonathan E McConathy
M.D. P.h.D., Director for the Division Molecular Imaging and Therapeutics
University of Alabama at Birmingham