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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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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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
How many people
140 participants
Where
No sites listed yet
Study dates
25 Sep 2025to 25 Oct 2026
Phase
Observational
Are there results?
Not yet: the study is under way

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.

Madona S Anis contact

+20 109 179 1874

Madona.17289597@med.aun.edu.eg

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.

  1. 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)

  1. Procedural success of PPCI

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

    Measured: Immediately post-procedure

  2. 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.

  1. First posted2 Oct 2025
  2. Study start25 Sep 2025 (estimated)
  3. Primary completion25 Sep 2026 (estimated)
  4. Study completion25 Oct 2026 (estimated)

Resources

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)
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 36237223

  • 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.

    PubMed 10733371

  • 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.

    PubMed 28886621

  • 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.

    PubMed 40452651

  • 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.

    PubMed 39142002

  • 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.

    PubMed 40125936

  • 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.

    PubMed 39767174

  • 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.

    PubMed 38985666

  • Han 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

Questions about this trial

What is this clinical trial studying?

An observational study of Primary Percutaneous Coronary Intervention, run by Assiut University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Madona S Anis (+20 109 179 1874, Madona.17289597@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Short-term major adverse cardiac events (MACE) (time frame: Through hospital stay (up to 3 days) and at one-month follow-up post-intervention.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07203573, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.

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