Preliminary Evaluation of 64Cu-DOTA-ECL1i in Patients Post-ST-Elevation Myocardial Infarction(STEMI)

Washington University School of Medicine1 个研究点分布在 1 个国家目标入组 90 人开始时间: 2018年11月24日最近更新: 2022年11月23日

适应症

干预措施

试验速览

阶段: 1 期
状态: 招募中
发起方: Washington University School of Medicine
入组人数: 90
试验地点: 1
主要终点: Number of participants who have heart disease as shown in the images

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

To determine the feasibility of 64Cu-DOTA-ECL1i, an investigational PET imaging drug, at the cellular level in the myocardium for individuals who have suffered a heart attack or who have other inflammatory heart disease.

详细描述

To determine the feasibility of 64Cu-DOTA-ECL1i to detect CCR2+monocytes and macrophages which are cells that are responsible for protecting tissues from foreign substances in the myocardium by PET/MR and PET/CT.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Parallel
主要目的: Diagnostic
盲法: None

入排标准

年龄范围: 21 Years 至 80 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•Healthy Volunteers:
•Age 21 to 80 years of either sex, any race
•Capable of lying still and supine within the PET/CT and PET/MR scanner for 1 hour and follow instructions for breathing protocol during the CT portion
•No illicit drug use or other inhaled drug use (including pharmacologic agents, recreational agents, or illicit drugs) within the past year
•No known history of cardiac. pulmonary, hepatic, or renal disease or diabetes
•No history of claustrophobia or other preventing condition that has previously or would interfere with completion of protocol-specified imaging sessions
•Able to comprehend and willing to follow instructions for the study procedures as called for by the protocol.
•Inflammatory Heart Disease
•Age 21 to 80 years of either sex, any race who have suffered a STEMI within the past 6 months as well as other forms of inflammatory heart disease including sarcoidosis, myocarditis, cardiomyopathy, injected cardiovascular implantable electronic devices pacemakers/LVAD
•Are clinically stable to undergo imaging with either PET/MR or PET/CT.
•Capacity to give written informed consent and ability to follow study procedures
•Pre-menopausal women must have a negative urine pregnancy test within 24 hours prior to the administration of 64-Cu-DOTA-ECL1i.

排除标准

•Healthy volunteers:
•Currently enrolled in another study using an investigational drug
•Uncontrolled heart failure
•uncontrolled hypertension baseline hypotension below 90/50
•Has any condition that in the opinion of the PI or designee that could increase risk to the subject
•Is deemed likely to be unable to perform all research procedures
•Have contraindications to PET/CT imaging like claustrophobia
•Have contraindication to gadolinium
•Pregnant or breastfeeding
•Currently using recreational drubs
•Body weight of more than 300 lbs
•Active symptoms or history of cardiac, pulmonary, hepatic or renal disease or diabetes
•currently taking any prescription medications
•Presence of an implanted device incompatible with CT or MRI scanning Inflammatory Heart Disease
•Clinically unstable including post MI angina, uncontrolled heart failure, sever hypertension, hypotension AV block 2) Has any condition that in the opinion of the PI could increase risk to the subject 3) Claustrophobia 4) contraindication to gadolinium contrast 5) Pregnant 6) Currently using recreational drugs 7) Body Weight more than 300 lbs 8) Currently enrolled in another study