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The iCORONARY Caristo biomarker study

The iCORONARY Caristo biomarker study - iCORONARY-Caristo/Biomarker

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON56410
Enrollment
400
Registered
2023-12-07
Start date
2023-12-01
Completion date
Unknown
Last updated
2024-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary artery disease coronary artery stenoses

Interventions

None listed

Sponsors

Sint Antonius Ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: All potential participants will be derived from the ICORONARY registry, meaning iCORONARY inclusion criteria apply, These can be found in the protocol, paragraph 4 section 2: inclusion criteria. Additional inclusion criteria that apply to participants in this study are: • The subject is between 30 and 80 years of age • The subject is included in the iCORONARY registry by researchers in the St. Antonius Hospital • The subject has no anatomically significant coronary artery disease on index CCTA (CADRADS 0-2)

Exclusion criteria

Exclusion criteria: All potential participants will be derived from the ICORONARY registry, meaning iCORONARY exclusion criteria apply, These can be found in the protocol, paragraph 4 section 3: exclusion criteria. In addition to all iCORONARY-exclusion criteria (as inclusion for iCORONARY registry indicates that none of these exclusion criteria are met) • The subject is suffering from chronic inflammatory diseases or (auto)immune disorders • The subject is suffering from an active malignancies and/or currently receives treatment for a malignancy • The subject is currently receiving oral, systemic or long-term cutaneous steroid therapy, or any other oral or systemic immune-suppressive medications.

Design outcomes

Primary

MeasureTime frame
The primary objective of this study is to investigate: • The difference after 1 year with and without cardiovascular risk modification: o in CaRi Heart Score o in Biomarker-levels o in traditional CT-parameters such as calcium score and CAD RADS score

Secondary

MeasureTime frame
this study also addresses the secondary objectives below: • Correlation between CaRi Heart Score, QRISK 3 score, ESC SCORE2 and biomarker levels at baseline and after 1 year • Ability of CaRi Heart score to predict major adverse cardiac events and CAD progression • Added value of biomarker-levels to CaRi Heart score event prediction

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)