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临床试验/NCT04940247
NCT04940247已完成不适用

Myocardial Perfusion Imaging by Combined 15O-H2O PET and MR for Evaluation of Reversible Myocardial Ischemia

University of Aarhus1 个研究点 分布在 1 个国家目标入组 73 人开始时间: 2021年2月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
73
试验地点
1
主要终点
Prognostic value within 10 years

研究概览

简要总结

The trial will include 75 patients with evident or suspected ischemic heart disease refered to Department of Nuclear Medicine & PET Centre, Aarhus University Hospital, for perfusion imaging by 15O-H2O PET/CT scan of the heart during rest and stress. Instead of the clinical scan participants will undergo perfusion imaging by 15O-H2O PET/MR.

The clinician will receive diagnostic information based on the 15O-H2O PET scan as if the patient had not participated in the study. As such, the study has no influence on the diagnostics or treatments of the patient.

Data from the scans will be used to compare 15O-H2O PET with cardiac MR for evaluation of myocardial perfusion.

Follow up will be done for up to 10 years in regards to major cardiovascular events in order to determine the prognostic value of the scan.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Refered for myocardial perfusion imaging by O15-H2O PET at Department of Nuclear Medicine & PET Centre, Aarhus University Hospital
  • > 18 years of age

排除标准

  • Allergic to adenosine
  • Allergic to gadolinium
  • Pregnancy
  • Claustrophobia
  • Severe Asthma
  • Pacemaker or other ferro-magnetic implants
  • GFR < 30

结局指标

主要结局

Prognostic value within 10 years

时间窗: 10 years

Number of participants who experience a major adverse cardiac event within 10 years of follow-up.

Difference in myocardial blood flow

时间窗: 2 years

The difference in assessed myocardial blood flow as measured by 15O-H2O PET and MR

次要结局

  • Prognostic value within 3,5 years(5 years)
  • Difference in predictive value(10 years)
  • Difference in left ventricular mass(2 years)
  • Pulmonary transit time(2 years)
  • Difference in coronary flow reserve(2 Years)
  • Difference in right ventricular end-diastolic volume(2 years)
  • Pulmonary perfusion(2 years)
  • Difference in left ventricular end-systolic volume(2 years)
  • Difference in left ventricular end-diastolic volume(2 years)
  • Difference in right ventricular end-systolic volume(2 years)
  • Amount of scar tissue(2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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