Native T1 Cardiac Magnetic Resonance Imaging for Diagnosis of Cardiac Amyloidosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 112
- 试验地点
- 2
- 主要终点
- Diagnostic accuracy of native T1 LV mapping for diagnosis of CA
研究概览
简要总结
The study aims to test the diagnostic accuracy of T1 mapping for the diagnosis of cardiac amyloidosis prospectively. The hypothesis is that T1 mapping in older patients with symptomatic heart failure, increased LV wall thickness and elevated cardiac biomarkers is non-inferior to the reference method to diagnose cardiac amyloidosis (CA).
As secondary measure, a web-based ATTR probability estimator for the diagnosis of CA will be evaluated.
详细描述
Cardiac amyloidosis (CA) is an important differential diagnosis in older patients with symptomatic heart failure with preserved or mid-range ejection fraction and increased left ventricular wall thickness. The prevalence of CA among patients with heart failure and left ventricular (LV) hypertrophy is approximately 13%. However, diagnosis of CA is challenging because specific clinical signs are often lacking.
Amyloid fibrils deposit in the extracellular space of the myocardium increases myocardial T1 values on cardiac magnetic resonance (CMR). Therefore, T1 imaging provides a promising non-invasive method to identify CA.
A preliminary retrospective analysis of 128 patients with increased LV wall thickness identified an area under the curve of 0.9954 (p<0.0001) for native T1 to detect CA. The optimal cut-off value was 1341ms, with a sensitivity of 100% and a specificity of 97%.
The investigators aim to test the diagnostic accuracy of T1 mapping for the diagnosis of CA compared to the reference method prospectively. Moreover, the web-based ATTR probability estimator for the diagnosis of CA will be evaluated.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 60 years
- •Symptomatic heart failure (NYHA II-IV) with LVEF ≥40%
- •Increased LV wall thickness (≥12mm end-diastolic)
- •NT-proBNP ≥1000pg/mL
- •Elevated hs-troponin T ≥14ng/L
排除标准
- •Contraindications for CMR
- •Acute myocarditis
- •Acute myocardial infarction <1 month
- •Severe aortic stenosis and RAISE score < 2 points
研究组 & 干预措施
CMR T1 mapping
Diagnostic accuracy of T1 mapping and ATTR probability estimator are tested against the reference methods (99mTc-DPD scintigraphy, laboratory screening for multiple myeloma / AL amyloidosis; or cardiac biopsy, if noninvasive evaluation is inconclusive)
干预措施: Native T1 CMR (Diagnostic Test)
CMR T1 mapping
Diagnostic accuracy of T1 mapping and ATTR probability estimator are tested against the reference methods (99mTc-DPD scintigraphy, laboratory screening for multiple myeloma / AL amyloidosis; or cardiac biopsy, if noninvasive evaluation is inconclusive)
干预措施: Web-based ATTR probability estimator (Pfizer, New York) (Diagnostic Test)
CMR T1 mapping
Diagnostic accuracy of T1 mapping and ATTR probability estimator are tested against the reference methods (99mTc-DPD scintigraphy, laboratory screening for multiple myeloma / AL amyloidosis; or cardiac biopsy, if noninvasive evaluation is inconclusive)
干预措施: 99mTc-DPD scintigraphy (Diagnostic Test)
CMR T1 mapping
Diagnostic accuracy of T1 mapping and ATTR probability estimator are tested against the reference methods (99mTc-DPD scintigraphy, laboratory screening for multiple myeloma / AL amyloidosis; or cardiac biopsy, if noninvasive evaluation is inconclusive)
干预措施: Laboratory screening for multiple myeloma / AL amyloidosis (Diagnostic Test)
CMR T1 mapping
Diagnostic accuracy of T1 mapping and ATTR probability estimator are tested against the reference methods (99mTc-DPD scintigraphy, laboratory screening for multiple myeloma / AL amyloidosis; or cardiac biopsy, if noninvasive evaluation is inconclusive)
干预措施: Cardiac biopsy (Procedure)
结局指标
主要结局
Diagnostic accuracy of native T1 LV mapping for diagnosis of CA
时间窗: up to 7 days
Comparison native T1 CMR with the reference method for diagnosis of CA
Diagnostic accuracy of T1 mapping for diagnosis of CA
时间窗: up to 7 days
Comparison of CMR T1 mapping to the reference method for diagnosis of CA
次要结局
- Association of native T1 values with cardiovascular outcome(1 years)
- Association of ATTR probability estimator values with cardiovascular outcome(1 year)
- Diagnostic accuracy of ATTR probability estimator to predict CA(up to 7 days)
- Association of parametric T1 values with cardiovascular outcome(1 year)
研究者
Daniel Lavall
Cardiologist
University of Leipzig