EARLY Risk Stratification in CardioMYOpathies With Unknown Etiology for Heart Failure
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- hospitalization due to heart failure
研究概览
简要总结
The investigators aimed to use CMR technique in helping diagnose the etiology of unknown cardiomyopathy. Try to make a risk stratification of susceptible heart failure based on the extent of myocardial impairment.
详细描述
Cardiomyopathy is a category of multiple causes of myocardial injury in structure and function, of which unexplained cardiomyopathy was most worried by cardiologists. Since the etiology confirmation sometimes still lacks of effective tools, therefore it can not be treated against etiology and may gradually developing to systolic or diastolic heart failure. The development of heart failure can be in different speeds, varying degrees, inconsistent in reversibility, and distinct response to treatment of heart failure.
In "real-world", ECG , cardiac ultrasound and myocardial enzymology can not be the whole to indicate the etiology of heart failure, so a strong clinical tool in the existing auxiliary examination is urgently needed and help to assess the risk of potential heart failure, therefore a reasonable treatment time window can be proposed.
The investigators aimed to use CMR technique in helping diagnose the etiology of unknown cardiomyopathy. Try to make a risk stratification of susceptible heart failure based on the extent of myocardial impairment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with cardiomyopathy diagnosed by medical history, clinical symptoms, laboratory tests including ECG, echocardiography.
- •no known etiology of cardiomyopathy was confirmed.
排除标准
- •with contraindications of magnetic resonance include: 1, participants with cardiac pacemakers and nerve stimulator; 2, participants who have done aneurysm surgery and intracranial with aneurysm folder; 3, participants with the metal foreign body in the eye; 4, pregnant women; 5, critically ill participants need life support systems; 6, epilepsy participants; 7, claustrophobic participants;.
- •participants who are <15 years of age or >75 years.
- •participants who have the contraindication use of contrast media: glomerular filtration rate <30 ml/min
研究组 & 干预措施
etiology unconfirmed without acute HF
Participants who were not identified with cardiac magnetic resonance (CMR) in etiology and without acute hearts failure (HF) were treated with drug with anti-myocardial remodeling.
干预措施: anti-myocardial remodeling (Drug)
with CMR confirmed etiology
Participants who were identified with cardiac magnetic resonance (CMR) in etiology were treated with drug including etiologic treatment,anti-myocardial remodeling.
干预措施: etiologic treatment,anti-myocardial remodeling (Drug)
etiology unconfirmed with acute HF
Participants who were not identified with CMR in etiology but with acute hearts failure were treated with drug with anti-myocardial remodeling,anti-acute heart failure.
干预措施: anti-myocardial remodeling,anti-acute heart failure (Drug)
etiology confirmed with acute HF
Participants who were identified with CMR in etiology but with acute hearts failure were treated with drug with Etiological, anti-remodeling and symptom treatment.
干预措施: Etiological, anti-remodeling and symptom treatment (Drug)
结局指标
主要结局
hospitalization due to heart failure
时间窗: 6 months after the first visit
Evaluate the relationship between scar amount and hospitalization due to heart failure
次要结局
- mortality(6 months after the first visit)
- malignant arrythmia(6 months after the first visit)