Effects of Remote Ischemic Conditioning on Myocardial Perfusion in Humans
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Changes in myocardial blood flow (MBF)
研究概览
简要总结
Cardiovascular disease is the second leading cause of death in Denmark, and ischemic heart disease accounts for the bulk of it. The purpose of this study is to clarify whether a mechanical method of remote ischemic conditioning in the form of short-term obstruction of the blood supply to the arm, can improve the heart's blood supply in patients with ischemic heart disease. This will be attempted through experiments on patients with ischemic heart disease and experimental animal studies with simulated cardiovascular disease.
This study will help to clarify whether remote ischemic preconditioning can be used to treat patients with ischemic heart disease.
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
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients referred for routine myocardial Rb82-PET scanning at Dept. of Nuclear Medicine & PET center, Aarhus University Hospital, Skejby, Denmark.
- •Able to understand the written patient information and to give informed consent.
排除标准
- •Patients not undergoing Rb82-PET with adenosine stress test.
- •Strenuous exercise (running, bicycling, fitness), intake of beta-blockers or alcohol intake on the day before and on the day of investigation.
- •Pregnant/nursing women.
- •Fertile women not using contraceptives.
- •Patients in dialysis treatment.
- •Other concomitant disease or treatment that according to the investigator's assessment makes the patient unsuitable for study participation.
- •Known type 2 diabetes
结局指标
主要结局
Changes in myocardial blood flow (MBF)
时间窗: 2 hours - Measurements will be done immediately before/after intervention
MBF before and after intervention
次要结局
- Difference in MBF between ischemic and non-ischemic myocardial territories.(2 hours - Measurements will be done immediately before/after intervention)
- Difference in MBF between patients with and without ischemic heart disease detectable by Rb82-PET.(2 hours - Measurements will be done immediately before/after intervention)
- Cardioprotection by the intervention measured by an increase in myocardial salvage in isolated rabbit hearts studied in a Langendorff model.(6 months following last patient last visit)
- Relation between changes in MBF and myocardial salvage in rabbit hearts(6 months following last patient last visit)
- • Differences in MBF between regions supplied by coronary arteries subsequently undergoing percutaneous intervention (PCI) and regions supplied by arteries not undergoing PCI(6 months following last patient last visit)