POSEIDON - Prevalence of systemic inflammation in patients with atherosclerotic cardiovascular disease and heart failure

JRCT ID: jRCT1070230051

Registered date:23/08/2023

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Atherosclerotic cardiovascular disease and Heart failure
• Date of first enrollment: 23/08/2023
• Target sample size: 1500
• Countries of recruitment: Argentina,Japan,Australia,Japan,Brazil,Japan,Canada,Japan,China,Japan,Czech Republic,Japan,Denmark,Japan,France,Japan,Germany,Japan,Hungary,Japan,India,Japan,Italy,Japan,South Korea,Japan,Norway,Japan,Poland,Japan,Sweden,Japan,United Kingdom,Japan,United States,Japan
• Study type: Observational

Outcome(s)

• Primary Outcome: Elevated hsCRP defined as hsCRP >=2 mg/L (yes/no) (Count of patient)

Secondary Outcome

Secondary endpoints
- IL-6 measures (pg/ml)
- NT-proBNP measures (pg/ml)
Exploratory endpoints
- Demography, medical history, clinical, laboratory and pharmacotherapy data
- FIB-4 index (score)
- ELF score (score)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable

Include criteria

Participants are eligible to be included in the study only if all the following criteria apply:
1. Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study.
2. Age 18 years or above at the time of signing the informed consent.
3. Presence of ASCVD and/or HF.
4. Presence of serum creatinine in the medical chart within 24 months prior to signing of informed consent (for ASCVD patients only).

Exclude criteria

Patients are excluded from the study if any of the following criteria apply:
1. Previous participation in this study. Participation is defined as having given informed consent in this study.
2. Current participation (i.e., signed informed consent) in any other interventional clinical study.
3. Any hospitalization or unplanned visit within the last 60 days (including exacerbation of chronic disease with hospitalization).
4. Clinical evidence, or suspicion of, active infection within the last 60 days.
5. Mental incapacity, unwillingness, or language barriers precluding adequate understanding or cooperation.

Related Information

• Primary Sponsor: Tsujita Kenichi