Improved Detection of Myocardial Fibrosis: a CMR Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- The presence of focal or diffuse myocardial fibrosis
研究概览
简要总结
Myocardial fibrosis, or scarring, is a common endpoint in many cardiomyopathies and is associated with adverse outcomes, and precise tools to measure myocardial fibrosis are needed. Focal and diffuse myocardial fibrosis can be diagnosed by cardiovascular magnetic resonance (CMR) imaging. However, the CMR procedure is complex and time-consuming and require the use of intravenous gadolinium based contrast agents. A wide range of biomarkers have been associated with the diagnosis and prognosis of cardiovascular disease. In the current study the investigators will assess whether novel and established circulating myocardial biomarkers associate with myocardial fibrosis assessed by CMR. The investigators will also assess whether novel or improved CMR sequences as well as machine learning algorithms improve image quality and the detection of myocardial fibrosis.
详细描述
This is an observational study of adult patients with suspected myocardial disease referred to cardiovascular magnetic resonance (CMR) with gadolinium contrast. The goal of the study is to assess whether novel and established circulating myocardial biomarkers associate with myocardial fibrosis assessed by CMR. The investigators will also assess novel techniques for detecting myocardial fibrosis by CMR. The plan is to include 1000 patients prior to CMR at Akershus University Hospital.
Blood samples for biomarker measurement will be obtained at the time of CMR. Image quality of novel CMR sequences will be recorded. The diagnostic results of the CMR will be compared to the levels of selected circulating biomarkers of myocardial injury and fibrosis. Novel sequences and techniques for assessing myocardial fibrosis by CMR will be compare to established techniques. Patients will be followed for a minimum of 12 months and the incidence of cardiovascular death, all-cause mortality, acute coronary syndromes, revascularization, heart failure, stroke and cardiac arrhythmias requiring rehospitalization will be recorded. Long-term follow-up information will be obtained from relevant registries
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
- 否
入选标准
- •Consecutive adult patients referred for clinically indicated cardiovascular magnetic resonance (CMR) imaging with gadolinium contrast at Akershus University Hospital will be invited to participate.
排除标准
- •Participants with contraindication for gadolinium contrast or inability to consent will be excluded
结局指标
主要结局
The presence of focal or diffuse myocardial fibrosis
时间窗: Baseline
Focal myocardial fibrosis assessed by late gadolinium enhancement (LGE) and diffuse myocardial fibrosis assessed by the extracellular volume fraction (ECV) by cardiovascular magnetic resonance (CMR) imaging
次要结局
- Composite of cardiovascular death and major adverse cardiac events (MACE)(Up to seven years)
研究者
Siri Lagethon Heck
Associate professor and consultant radiologist
University Hospital, Akershus