A Prospective Multicenter Study for the Assessment of Biomarker Signatures for the Diagnosis of Pulmonary Hypertension (PH) in Patients at Low or Intermediate Probability of PH Undergoing Cardiac Magnetic Resonance Imaging (MRI) CIPHER-MRI
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 86
- 试验地点
- 16
- 主要终点
- Percentage of Participants in the Population Considered Clinically as not Having PH that are Positive for PH Biomarker
研究概览
简要总结
The primary purpose of this study is to estimate the percentage of participants in the population considered clinically as not having pulmonary hypertension (PH) that are positive for PH biomarker (micro ribonucleic acid [RNA]); estimate the percentage of participants in the population considered clinically as not having PH that are positive for PH by cardiac magnetic resonance imaging (MRI) and compare results of the MRI to the biomarker results; to determine the performance of the biomarker signatures identified in the CIPHER (NAPUH0001) study in terms of sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV), in a population considered clinically as not having PH.
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
- •Referred for diagnostic work-up for pulmonary hypertension (PH)
- •With low or intermediate (but not high) probability of PH by transthoracic echocardiography (TTE) according to European Society of Cardiology (ESC)/ European Respiratory Society (ERS) Guidelines if at the time of enrollment Right Heart Catheterization (RHC) is not deemed to be clinically indicated
- •Medically stable on the basis of physical examination, medical history and vital signs performed at screening. Any abnormalities must be consistent with the underlying illness in the study population and this determination must be recorded in the participant's source documents and initialed by the investigator
- •Must sign an Informed consent (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study
- •Must sign a separate approval in the ICF if he or she agrees to provide an optional (DNA) sample for research. Refusal to give consent for the optional (DNA) research sample does not exclude a participant from participation in the study
排除标准
- •Undergone RHC within 2 years
- •Participants requiring renal dialysis
- •Participants post-lung or heart transplant
- •Severe left ventricular dysfunction: left ventricular ejection fraction less then (<) 35 percent
- •Ongoing Contagious respiratory disease
结局指标
主要结局
Percentage of Participants in the Population Considered Clinically as not Having PH that are Positive for PH Biomarker
时间窗: Up to 90 Days
Percentage of (transthoracic echocardiography \[TTE\] low/intermediate probability) participants who are positive for the biomarker will be estimated.
Performance of Biomarker Results
时间窗: Up to 90 Days
The performance of the biomarker in the diagnosis of PH will be evaluated using the MRI result.
Percentage of Participants Considered Clinically as not Having PH that are Positive for PH by Cardiac MRI
时间窗: Up to 90 Days
Percentage of participants considered clinically as not having PH that are positive for PH by cardiac magnetic resonance imaging (MRI) will be evaluated.
Performance of the Biomarker Signatures Identified in the CIPHER Study in Terms of Sensitivity, specificity, positive predictive value (PPV) and Negative Predictive Value (NPV), in Participants not Having PH
时间窗: Up to 90 Days
Performance of the biomarker signatures identified in the CIPHER study in terms of sensitivity, specificity, PPV and NPV, in a population considered clinically as not having PH will be estimated.
次要结局
- Biomarker Data Pooled with the Biomarker Data Collected from the CIPHER (NAPUH0001) Study(Up to 90 Days)