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

Not Applicable

• Conditions: Atherosclerotic cardiovascular disease and Heart failure; Atherosclerotic cardiovascular disease, Heart failure, ASCVD, HF; D050197 ,D006333

• Registration Number: JPRN-jRCT1070230051
• Lead Sponsor: Tsujita Kenichi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-08-23
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 1500

Inclusion 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).

Exclusion 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.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Elevated hsCRP defined as hsCRP >=2 mg/L (yes/no) (Count of patient)

Secondary Outcome Measures

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