Prognostic Value of the CALLY Index in Patients Undergoing Primary PCI
- Conditions
- Primary Percutaneous Coronary Intervention
- Registration Number
- NCT07203573
- Lead Sponsor
- Assiut University
- Brief Summary
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.
- Detailed Description
* 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
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 140
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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Short-term major adverse cardiac events (MACE) 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 Outcome Measures
Name Time Method Procedural success of PPCI Immediately post-procedure Achievement of final TIMI 3 flow grade post-intervention without in-hospital complications.
Coronary artery disease complexity by SYNTAX score ( (Synergy Between PCI With Taxus and Cardiac Surgery score) 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.