Early Identification of Cardiac Involvement in Patients With Carcinoid: Clinical and Prognostic Implications
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- blood levels of biomarkers of cardiac damage
研究概览
简要总结
This study is for patients with neuroendocrine tumours (NET) with or without carcinoid syndrome followed by NET Unit of European Institute of Oncology.
The objective of the trial is to evaluate biochemical markers of myocardial injury (high-sensitive troponins), haemodyinamic markers (pro-brain natriuretic peptide (BNP), N-terminal (NT)-BNP (NT-proBNP)), and markers of fibrosis (Suppression of Tumorigenicity 2 (ST2) in patients with neuroendocrine tumours (NET) with or without carcinoid syndrome.
详细描述
The main aim of this study is to evaluate blood levels of biomarkers of cardiac damage (ultra-sensitive troponin I), hemodynamic impairment (BNP, NT-proBNP), and cardiac fibrosis (ST2) in patients with diagnosed neuroendocrine tumours (NET) with or without carcinoid syndrome The secondary objective is to correlate the levels of the above markers with the presence/entity of cardiac involvement and its progression over time.
All patients will undergo:
-
a baseline assessment including:
-
blood sampling for US-Troponin I, BNP, NT-proBNP, ST2
-
cardiological evaluation including ECG and echocardiogram
-
a three-monthly revaluation of these markers
-
a six monthly cardiological reassessment with a echocardiogram
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •patients diagnosed with metastatic NET with or without carcinoid referred to the Unit of Neuroendocrine Tumors of European Institute of Oncology
排除标准
- •age <18 years
- •patients diagnosed with heart disease prior to diagnosis of NET
研究组 & 干预措施
Evaluation of blood levels of biomarkers of cardiac damage
Evaluation of blood levels of biomarkers of cardiac damage (ultra-sensitive troponin I), hemodynamic impairment (BNP, NT-proBNP), and cardiac fibrosis (ST2) in patients with diagnosed neuroendocrine tumours (NET) with or without carcinoid syndrome
干预措施: Evaluation of blood levels of biomarkers of cardiac damage (Other)
结局指标
主要结局
blood levels of biomarkers of cardiac damage
时间窗: 3 months
Evaluation of blood levels of ultra-sensitive troponin I
blood levels of biomarkers of hemodynamic impairment
时间窗: 3 months
Evaluation of blood levels of BNP, NT-proBNP
blood levels of biomarkers of cardiac fibrosis
时间窗: 3 months
Evaluation of blood levels of ST2
次要结局
- Correlation between the levels of the biomarkers and the presence/entity of cardiac involvement(6 months)