POSEIDON – Prevalence of systemic inflammation in patients with atherosclerotic cardiovascular disease and heart failure
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 21,504
- 试验地点
- 18
- 主要终点
- To estimate the prevalence of systemic inflammation (defined as hsCRP ≥2 mg/L) in pre-defined cohorts of patients with ASCVD and/or HF, and subgroups hereof.
研究概览
简要总结
This is a cross-sectional, global, real-world prevalence study involving patients diagnosed with ASCVD and/or HF. There is only 1 planned study visit, during which patients will sign an informed consent form (ICF) and provide a blood sample. All efforts should be made to collect a blood sample at time of ICF signature, however if a patient is unable to provide a blood sample during this visit, they are permitted to return within 2 weeks of ICF signature. Full patient data will only be abstracted from patient records after a patient has provided a blood sample, and data will be abstracted to the date of the blood sample. Patients are recommended to be in a fasted state for collection of the blood sample, but this is not a requirement. In order to facilitate the required blood sample collection, sites may review patients’ medical charts to determine eligibility of patients with upcoming visits, discuss the study with the patient, and plan for the blood test to be performed during the same visit as ICF signature.
Patients will be invited sequentially to participate in the study during a 17-month enrolment period as they present for a routine visit to minimize bias in patient selection, and all eligible patients should be offered enrolment in the study.
Patients will be enrolled into the study and attributed to 4 pre-defined cohorts (note that patients may contribute to more than 1 cohort). This study defines CKD as having an estimated glomerular filtration rate (eGFR) <60 ml/min/1.73m2.
1. ASCVD with CKD (eGFR <60 ml/min/1.73m2)
2. ASCVD without CKD (eGFR ≥60 ml/min/1.73m2)
3. HF with preserved ejection fraction (HFpEF) or HF with mildly reduced ejection fraction (HFmrEF)
4. HF with reduced ejection fraction (HFrEF)
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Informed consent obtained before any study-related activities.
- •Study-related activities are any procedures that are carried out as part of the study.
- •Age 18 years or above at the time of signing the informed consent.
- •Presence of ASCVD and/or HF.
- •Presence of serum creatinine in the medical chart within 24 months prior to signing of informed consent (for ASCVD patients only).
排除标准
- •Previous participation in this study.
- •Participation is defined as having given informed consent in this study.
- •Current participation (i.e., signed informed consent) in any other interventional clinical study.
- •Any hospitalization or unplanned visit within the last 60 days (including exacerbation of chronic disease with hospitalization).
- •Clinical evidence, or suspicion of, active infection within the last 60 days.
- •Mental incapacity, unwillingness, or language barriers precluding adequate understanding or cooperation.
结局指标
主要结局
To estimate the prevalence of systemic inflammation (defined as hsCRP ≥2 mg/L) in pre-defined cohorts of patients with ASCVD and/or HF, and subgroups hereof.
时间窗: Primary objective will be assessed during subject visit date and there is only one subject visit in this study.
次要结局
- • To examine IL-6 stratified by the presence of systemic inflammation (defined as hsCRP ≥2 mg/L) in pre-defined cohorts of patients with ASCVD and/or HF, & subgroups hereof.(• To examine NT-proBNP stratified by the presence of systemic inflammation (defined as hsCRP ≥2 mg/L) in pre-defined cohorts of patients with HF, & subgroups hereof.)