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NCT Number: NCT07203573

Prognostic Value of the CALLY Index in Patients Undergoing Primary PCI

This study aims to evaluate the relationship between the admission CALLY index and short-term adverse outcomes in STEMI patients undergoing PPCI. Specifically, it seeks to determine whether the CALLY index is associated with in-hospital and 30-day complications, including heart failure, arrhythmias, reinfarction, or death. Additionally, the study will assess the association between the CALLY index and procedural success, defined by post-intervention TIMI flow, as well as the complexity of coronary artery disease using the SYNTAX score.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

  • ST-elevation myocardial infarction (STEMI) remains a leading cause of morbidity and mortality worldwide. Early risk stratification in patients undergoing primary percutaneous coronary intervention (PPCI) is crucial to predict adverse outcomes and optimize management.
  • The C-reactive protein-albumin-lymphocyte (CALLY) index is an emerging biomarker combining inflammation, nutrition, and immune status. Previous studies have demonstrated associations between the CALLY index and long-term mortality in cardiovascular disease, elderly populations, and STEMI patients . However, most of these studies focus on long-term outcomes or utilize complex predictive models (e.g., machine learning), and there is limited research assessing the direct relationship between admission CALLY index and immediate procedural outcomes, such as PPCI success or short-term adverse events., Unlike previous studies that included retrospective data, large national databases, or machine learning prediction models, this study will focus on a short-term, real-time assessment of the CALLY index at admission and its immediate association with procedural outcomes and in-hospital adverse events

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age ≥ 18 years

  • Diagnosis of STEMI based on 4th universal definition of myocardial infarction
  • Undergoing Primary PCI within guideline-recommended timeframes
  • Provided informed consent to participate in the study

Exclusion criteria

  • Active infection (as detected by baseline leukocytosis on admission), autoimmune or inflammatory disease affecting CRP, albumin, or lymphocyte counts
  • Chronic liver disease or advanced malignancy
  • Patients receiving immunosuppressive therapy
  • Refusal to participate

Treatment and study plan

Primary outcomes

  1. Short-term major adverse cardiac events (MACE)

    Time frame: Through hospital stay (up to 3 days) and at one-month follow-up post-intervention.

    Occurrence of MACE including heart failure, arrhythmias, reinfarction, cardiogenic shock, or death.

Secondary outcomes

  1. Procedural success of PPCI

    Time frame: Immediately post-procedure

    Achievement of final TIMI 3 flow grade post-intervention without in-hospital complications.

  2. Coronary artery disease complexity by SYNTAX score ( (Synergy Between PCI With Taxus and Cardiac Surgery score)

    Time frame: At the time of coronary angiography

    Assessment of the association between CALLY index at admission and coronary complexity determined by the SYNTAX (Synergy Between PCI With Taxus and Cardiac Surgery) score.

    The SYNTAX score ranges from 0 upwards, with scores categorized as 0-22 indicating low complexity and scores >22 indicating more complex coronary artery disease. Higher scores represent increased disease complexity.

Study contacts

Contact information is provided by the study sponsor or research team.

Madona S Anis

CONTACT

[email protected]

+20 109 179 1874

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Prognostic Value of the C-Reactive Protein-Albumin-Lymphocyte (CALLY) Index on Patients Undergoing Primary Percutaneous Coronary Intervention

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 2, 2025
Registry last updated
Oct 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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