Prognostic Value of the CALLY Index in Patients Undergoing Primary PCI

NCT07203573 | Not Yet Recruiting

• 1 other identifier: CALLY Index in PPCI Patients
• Study Type: observational
• Target: 140
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Primary Percutaneous Coronary Intervention

Outcome Measures

Primary Outcomes (1)

• Short-term major adverse cardiac events (MACE)

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

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

Secondary Outcomes (2)

• Procedural success of PPCI

  Immediately post-procedure

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

  At the time of coronary angiography

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (9)

• 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.

  PMID: 36237223 BACKGROUND

• Ridker 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.

  PMID: 10733371 BACKGROUND

• Ibanez 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.

  PMID: 28886621 BACKGROUND

• Demir 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.

  PMID: 40452651 BACKGROUND

• Ji 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.

  PMID: 39142002 BACKGROUND

• Guven 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.

  PMID: 40125936 BACKGROUND

• Fedai 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.

  PMID: 39767174 BACKGROUND

• Luo 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.

  PMID: 38985666 BACKGROUND

• Kelemen Z, Mai A, Kapros T, Feher A, Gyorgyey J, Waterborg JH, Dudits D. Transformation vector based on promoter and intron sequences of a replacement histone H3 gene. A tool for high, constitutive gene expression in plants. Transgenic Res. 2002 Feb;11(1):69-72. doi: 10.1023/a:1013923826979.

  PMID: 11874105 BACKGROUND

Central Study Contacts

Madona S Anis

CONTACT

+20 109 179 1874; Madona.17289597@med.aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: September 17, 2025
• First Posted: October 2, 2025
• Study Start: September 25, 2025
• Primary Completion (Estimated): September 25, 2026
• Study Completion (Estimated): October 25, 2026
• Last Updated: October 2, 2025

Record last verified: 2025-09