Identification of Prognostic Parameters in Patients With " Senile " Amyloid Cardiomyopathy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 142
- 试验地点
- 1
- 主要终点
- Prognostic value of myocardial perfusion heterogeneity index on mortality at 1 year in patients with senile cardiac amyloidosis.
研究概览
简要总结
The aging of the population is a reality in our society, with a strong increase in the number of elderly patients hospitalized for heart failure in our institutions. Heart failure in these patients is more present than to younger patients, with preserved ejection fraction form (HFpEF). Aging is responsible for the onset of senile amyloid cardiomyopathy. This pathology is still imperfectly understood and its link with the increase in the frequency of HFpEF is important. In addition, specific treatments have just shown their effectiveness. It is therefore urgent to better identify the prognostic predictive parameters of this cardiomyopathy.
The pathophysiological involvement of the coronary microcirculation responsible for a true microvascular coronary disease (CMVD) has been described as predictive factor in all cardiomyopathies. However the implementation of preventive strategies and / or therapeutic of the coronary microcirculation dysfunction are limited because we lack of diagnostic tests available and applicable to large cohorts of patients.
Our team INSERM U1039 Radiopharmaceutiques Biocliniques in collaboration with the laboratory GIPSA-lab (Grenoble Images Speech Signal Automatique), laboratory specialized in the signal analysis, has developed a new method of analysis allowing to measure the coronary microcirculation dysfunction usable in SPECT thanks to the measurement of a myocardial perfusion heterogeneity index (IHPM) (patented technique). The 3C registry (NCT03479580) is a registry studying the prevalence and cardiovascular prognosis of macro and microcirculatory coronary artery disease using the latest coronary evaluation techniques in patient with cardiomyopathy. This registry deployed on interventional cardiology centers on the Alpine Arc is therefore also addressed to patients with senile cardiomyopathy. The data collected will provide a better understanding of the factors influencing the prognosis of senile cardiomyopathy and the prognostic contribution of the measurement of the IHPM 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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patient, over 75 years old
- •Social Security Affiliate
- •Any patient with the diagnosis of cardiac amyloidosis after etiological evaluation in one of the 4 Alpin arc interventional cardiology centers (Grenoble University Hospital, GHM Grenoble, Annecy Hospital and Chambéry Hospital).
- •Non opposition to participation
排除标准
- •Concomitant ischemic cardiopathy with revascularization following cardiac scintigraphy exploration and subsequent coronary angiography.
- •Concomitant non-amyloid non-ischemic cardiopathy (valvular cardiopathy)
- •Major non-cardiac illness (eg, disseminated malignancy, severe neurological dysfunction at the time of diagnosis) or social condition that may preclude participation in a research study
- •Major patient protected by law (article L1121-8)
- •Person deprived of liberty (Article L1121-8)
结局指标
主要结局
Prognostic value of myocardial perfusion heterogeneity index on mortality at 1 year in patients with senile cardiac amyloidosis.
时间窗: 1 year
Rate of occurrence of the primary endpoint: all-cause mortality at 1 year
次要结局
- Correlations between IHMP and geriatric frailty.(Inclusion)
- Relationships between IHPM in cardiac scintigraphy and the rhythmic evaluations.(inclusion)
- Comparison of IHPM between patients with amyloid senile cardiomyopathy and a control population paired with age and sex.(Inclusion)
- Prognostic value of IHMP on hospitalizations for heart failure in patients with senile cardiac amyloidosis.(1 year)
- Relationships between IHPM and structural and functional measures in cardiac imaging in MRI.(Inclusion)
- Prognostic value of IHPM on the quality of life in patients with senile cardiac amyloidosis(1 year)
- Side effect of tafamidis in this population(1 year)
- Relationships between IHPM and structural and functional measures in cardiac imaging in cardiac ultrasound(Inclusion)