NCT06624293已完成不适用
Access BNP Assay Clinical Subject Sample Collection Enrollment Study Protocol
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,100
- 试验地点
- 17
- 主要终点
- Heart failure positive subjects
研究概览
简要总结
The goal of this study is to collect blood from subjects with a suspicion of either new onset or worsened heart failure to be used for testing studies for a new product to aid in the diagnosis of heart failure.
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
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to provide informed consent
- •Adult greater than or equal to 22 years old, any gender, race, ethnicity
- •Presenting with clinical suspicion of new onset heart failure or worsening symptoms suggestive of decompensated or exacerbated heart failure
- •Ability to fulfill study data collection requirements (including responding to questions for the NYHA evaluation)
排除标准
- •Individuals less than 22 years old
- •Impairment in individual's capacity to give informed consent
- •Dyspnea clearly not secondary to heart failure (e.g., primary lung disease or chest trauma).
- •On dialysis
- •On nesiritide infusion
- •Subject clinical/medical history access is not available to Sponsor, delegates, and FDA or other regulatory agencies upon request.
- •Active participation in a clinical study that may interfere with participation in this study (e.g., investigational drug study)
- •Reason(s) determined by the Principal Investigator that would place the individual at increased risk or preclude the individual from fully complying with or completing the study.
结局指标
主要结局
Heart failure positive subjects
时间窗: During initial assessment in emergency department
Subjects with BNP value above clinical decision point
次要结局
- Heart failure negative subjects(During initial assessment in emergency department)
研究者
研究点 (17)
Loading locations...
相似试验
招募中
不适用
A Clinicobiological Database in Metastatic Digestive CancersDigestive System NeoplasmNCT03978078Institut du Cancer de Montpellier - Val d'Aurelle200
终止
不适用
Blood Sample Collection to Evaluate Biomarkers in Subjects With Untreated MelanomaMelanomaNCT03727087Exact Sciences Corporation348
终止
不适用
Blood Sample Collection to Evaluate Biomarkers in Subjects With Untreated Hematologic MalignanciesHematologic MalignancyNCT03727009Exact Sciences Corporation409
已完成
不适用
Blood Sample Collection to Evaluate Biomarkers in Subjects With Untreated Solid TumorsBreast CancerColorectal CancerLung CancerUterine CancerKidney CancerRenal Pelvis CancerProstate CancerOvarian CancerPancreatic CancerBladder CancerEsophageal CancerLiver CancerStomach CancerNCT03662204Exact Sciences Corporation5,133
Enrolling By Invitation
不适用
Lyme Disease Diagnostic Assay - Collection of Whole BloodHealthyLyme DiseaseNCT05041595DiaSorin Inc.450