Syndecan-4 as a Biomarker in Patients With Chagas Disease
Validation of Syndecan-4 as a Biomarker for Determining Patients Prognosis With Chagas Disease.
研究概览
地位
条件
详细说明
Increased serum levels of syndecan-4 have been correlated to acute myocardial infarction and chronic heart failure, suggesting that this molecule can be an important biomarker in heart diseases. In spite of that, there are no studies that have investigated the role of this molecule in chronic chagasic cardiomyopathy yet.
In this project, our objective is to demonstrate the potential role of syndecan-4 in the prognosis of chronic chagasic cardiomyopathy, seeking a better fitting of the treatment through the identification of patients with the worse prognosis.
The patients included in the study must at first sign the written consent. They shall be accompanied in the specialized outpatient clinics for Chagas disease - Hospital São Rafael - Centro de Biotecnologia e Terapia Celular. They will be submitted to several tests, including:
- Collection of Blood samples for biochemical analysis;
- Electrocardiogram;
- Holter Electrocardiogram;
- Echocardiogram;
- Treadmill Test;
- X-Ray Imaging;
- Magnetic Resonance Imaging;
- Evaluation of the quality of life through the application of questionnaires (SF 36 and the Minnesota Living With Heart Failure Questionnaire).
研究类型
注册 (实际的)
联系人和位置
学习地点
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Bahia
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Salvador、Bahia、巴西、41253-190
- Hospital Sao Rafael
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Chagas disease diagnosis confirmed by 2 different serologies
- Diagnosis of Chagas disease in both forms: indeterminate and cardiac ones, with and without ventricular dysfunction.
Exclusion Criteria:
- Significant valve disease defined as aortic stenosis with a gradient of VE/Ao > 50 mmHg
- Mitral stenosis with a valve area inferior than 1,5 cm2
- Superior or moderated aortic and/or mitral regurgitation
- Chronic use of immunosuppressive agents
- Dialysis treatment of terminal renal failure
- Fever on the last 48 hours or evidence of systemic infection in activity according to the definition of sepsis of the ACCP/SCCM (American College os Chest Physicians/Society of Critical Care Medicine)
- Current abusive use of alcohol or illicit drugs (Based on the DSM IV)
- Any other comorbidities that impact patient's survival within the next 2 years
- Liver disease in activity
- Continuous use of steroids as treatment for COPD
- Hematologic, neoplastic or bone diseases
- Homeostasis disturbances
- Inflammatory diseases or chronic infectious diseases
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
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南美锥虫病诊断患者
南美锥虫病的两种形式的诊断：不确定的和心脏的，伴有和不伴有心室功能障碍。
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Correlation of plasmatic levels of syndecan-4 with the percentage of heart fibrosis
大体时间：One year
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Mensuration of heart fibrosis percentage with Magnetic Resonance Imaging
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One year
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Correlation of plasmatic levels of syndecan-4 with the functional cardiovascular capacity
大体时间：One year
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Mensuration of the functional capacity with treadmill test.
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One year
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Correlation of plasmatic levels of Syndecan-4 with the left ventricular function
大体时间：One year
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Mensuration of the left ventricular function with echocardiogram and magnetic resonance imaging
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One year
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Correlation of plasmatic levels of Syndecan-4 with the serum levels of Pro-BNP.
大体时间：One year
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One year
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Correlation of plasmatic levels of Syndecan-4 with the serum levels of TNF-alpha
大体时间：One year
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One year
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Correlation of plasmatic levels of Syndecan-4 with the serum levels of IFN-gamma.
大体时间：One year
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One year
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合作者和调查者
调查人员
- 首席研究员：Milena Botelho Pereira Soares, PhD、Hospital Sao Rafael
- 学习椅：Carolina Thé Macedo, MD、Hospital Sao Rafael
- 研究主任：Ricardo Ribeiro dos Santos, MD、Hospital Sao Rafael
- 学习椅：Ticiana Ferreira Larocca, MD、Hospital Sao Rafael
- 学习椅：Márcia Maria Noya Rabelo, MD、Hospital Sao Rafael
- 学习椅：Luís Cláudio Lemos Correia, MD、Hospital Sao Rafael
- 学习椅：Bruno Solano de Freitas Souza, MD、Hospital Sao Rafael
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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