Primary Percutaneous Coronary InterventionNCT07203573
Prognostic Value of the CALLY Index in Patients Undergoing Primary PCI
An observational study of Primary Percutaneous Coronary Intervention, run by Assiut University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Percutaneous Coronary Intervention
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- 25 Sep 2025to 25 Oct 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: The study population will consist of adult patients (≥18 years) presenting with STEMI to the emergency department and receiving PPCI as the main management
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Prognostic Value of the C-Reactive Protein-Albumin-Lymphocyte (CALLY) Index on Patients Undergoing Primary Percutaneous Coronary Intervention
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.
Read the 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
What is being measured
The primary outcome is the main question the study is designed to answer.
Short-term major adverse cardiac events (MACE)
Occurrence of MACE including heart failure, arrhythmias, reinfarction, cardiogenic shock, or death.
Measured: Through hospital stay (up to 3 days) and at one-month follow-up post-intervention.
Secondary outcomes (2)
Procedural success of PPCI
Achievement of final TIMI 3 flow grade post-intervention without in-hospital complications.
Measured: Immediately post-procedure
Coronary artery disease complexity by SYNTAX score ( (Synergy Between PCI With Taxus and Cardiac Surgery score)
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.
Measured: At the time of coronary angiography
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study start25 Sep 2025 (estimated)
- Primary completion25 Sep 2026 (estimated)
- Study completion25 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Primary Percutaneous Coronary InterventionStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Madona Samy Anis, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07203573
- Sponsor's protocol ID
- CALLY Index in PPCI Patients
- Status last verified
- Sep 2025
- First submitted
- 17 Sep 2025
- Last updated
- 2 Oct 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kumar R, Shah JA, Solangi BA, Ammar A, Kumar M, Khan N, Sial JA, Saghir T, Qamar N, Karim M. The Burden of Short-term Major Adverse Cardiac Events and its Determinants after Emergency Percutaneous Coronary Revascularization: A Prospective Follow-up Study. J Saudi Heart Assoc. 2022 Jun 11;34(2):100-109. doi: 10.37616/2212-5043.1302. eCollection 2022.
PubMed 36237223Ridker PM, Hennekens CH, Buring JE, Rifai N. C-reactive protein and other markers of inflammation in the prediction of cardiovascular disease in women. N Engl J Med. 2000 Mar 23;342(12):836-43. doi: 10.1056/NEJM200003233421202.
PubMed 10733371Ibanez B, James S, Agewall S, Antunes MJ, Bucciarelli-Ducci C, Bueno H, Caforio ALP, Crea F, Goudevenos JA, Halvorsen S, Hindricks G, Kastrati A, Lenzen MJ, Prescott E, Roffi M, Valgimigli M, Varenhorst C, Vranckx P, Widimsky P; ESC Scientific Document Group. 2017 ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation: The Task Force for the management of acute myocardial infarction in patients presenting with ST-segment elevation of the European Society of Cardiology (ESC). Eur Heart J. 2018 Jan 7;39(2):119-177. doi: 10.1093/eurheartj/ehx393. No abstract available.
PubMed 28886621Demir Y, Sevinc S. The Prognostic Value of C-Reactive Protein-Albumin-Lymphocyte (CALLY) Index in Predicting In-Hospital Mortality After Primary Percutaneous Coronary Intervention in Patients With ST-Elevation Myocardial Infarction (STEMI). Catheter Cardiovasc Interv. 2025 Aug;106(2):1111-1118. doi: 10.1002/ccd.31623. Epub 2025 Jun 2.
PubMed 40452651Ji H, Luo Z, Ye L, He Y, Hao M, Yang Y, Tao X, Tong G, Zhou L. Prognostic significance of C-reactive protein-albumin-lymphocyte (CALLY) index after primary percutaneous coronary intervention in patients with ST-segment elevation myocardial infarction. Int Immunopharmacol. 2024 Nov 15;141:112860. doi: 10.1016/j.intimp.2024.112860. Epub 2024 Aug 13.
PubMed 39142002Guven B, Deniz MF, Geylan NA, Kultursay B, Donmez A, Bulat Z, Gul OB, Kaya M, Oktay V. A novel indicator of all-cause mortality in acute coronary syndrome: the CALLY index. Biomark Med. 2025 Apr;19(8):287-294. doi: 10.1080/17520363.2025.2483159. Epub 2025 Mar 24.
PubMed 40125936Fedai H, Sariisik G, Toprak K, Tascanov MB, Efe MM, Arga Y, Doganogullari S, Gez S, Demirbag R. A Machine Learning Model for the Prediction of No-Reflow Phenomenon in Acute Myocardial Infarction Using the CALLY Index. Diagnostics (Basel). 2024 Dec 14;14(24):2813. doi: 10.3390/diagnostics14242813.
PubMed 39767174Luo L, Li M, Xi Y, Hu J, Hu W. C-reactive protein-albumin-lymphocyte index as a feasible nutrition-immunity-inflammation marker of the outcome of all-cause and cardiovascular mortality in elderly. Clin Nutr ESPEN. 2024 Oct;63:346-353. doi: 10.1016/j.clnesp.2024.06.054. Epub 2024 Jul 2.
PubMed 38985666Han D, Wu L, Zhou H, Xue Y, He S, Ma Z, Su S, Li P, Liu S, Huang Z. Associations of the C-reactive protein-albumin-lymphocyte index with all-cause and cardiovascular mortality among individuals with cardiovascular disease: evidence from the NHANES 2001-2010. BMC Cardiovasc Disord. 2025 Mar 3;25(1):144. doi: 10.1186/s12872-025-04596-w.
PubMed 40025412