The Influence of Amyloid Protein on Myocardial Tissue Characteristics and Function: Prognostic and Diagnostic Significance of Cardiac Magnetic Resonance Findings
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Identification of cardiac amyloidosis using contrast cardiovascular MRI
研究概览
简要总结
Cardiac amyloidosis describes a process by which abnormally folded proteins infiltrate the heart tissue. Given the insidious nature of this disease process, diagnosis is often too late for a meaningful intervention. Advances in the treatment of the amyloidoses have improved outcomes for patients with these conditions. The focus of this study is to identify the involvement of the heart, most closely associated with mortality, so that aggressive management can be instituted improving prognosis.
详细描述
RESEARCH PROTOCOL
Hypothesis:
The presence of amyloid protein in the myocardium changes its function and tissue characteristics. These changes are responsible for the poor prognosis of patients with cardiac amyloidosis. Cardiac magnetic resonance imaging (CMR) offers a novel, non-invasive approach to identify cardiac involvement that may impact patient management. This study will include the prospective validation of CMR parameters qualified as being abnormal in the retrospective study (study ID 2012-3315) and the current literature. The myocardium/blood pool inversion time null point ratio (Myo/BlP TI0 ratio), has been qualified as being significantly different when compared to controls in the retrospective study.
Specific Aims:
- Validate the diagnostic accuracy of CMR parameters in a prospective manner for cardiac amyloidosis patients.
- CMR parameters, including the Myo/BlP TI0 ratio, will be compared to serum biomarkers (TroponinT, NT-proBNP, serum lambda/kappa free light chain concentration), established to have prognostic value in cardiac amyloidosis. Subjects will be followed via death registry and/or medical records to compare the prognostic value of the CMR parameter with the biomarkers.
- CMR parameters will be used to assess for the presence of early cardiac involvement in amyloidosis patients without clinically apparent cardiac involvement (as determined by symptoms, biomarkers and/or cardiac imaging).
- CMR will be used to follow patients undergoing treatment, when available, to determine whether CMR parameters consistent with the presence of cardiac amyloidosis, change during treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects meeting diagnostic criteria for the target population will be recruited for the study. Age range will be 18 to 85 years of age.
排除标准
- •Exclusion criteria will include history of heart transplantation as well as any contraindications for 1.5T CMR. For the use of GBCA, patients with acute renal failure or stage IV/V chronic renal failure will be excluded. Patients with end stage renal failure receiving peritoneal dialysis will also be excluded. Women who are pregnant or breast feeding will also be excluded.
结局指标
主要结局
Identification of cardiac amyloidosis using contrast cardiovascular MRI
时间窗: 2 years
次要结局
- All cause mortality(two years)
研究者
Robert O'Donnell
Associate Professor
University of Cincinnati