NCT06958562

Brief Summary

Aim(s) of the Research :

  1. 1.To assess the relationship between the lymphocyte-to-CRP ratio and CAD complexity as assessed by Syntax score in both emergency (STEMI patients undergoing PPCI) and elective settings (patients undergoing scheduled CA plus PCI).
  2. 2.To test the relation between the LCR ratio and short-term major adverse cardiac events (MACE) within 6 months duration in patient undergoing primary PCI.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2025

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 12, 2025

Completed
24 days until next milestone

First Posted

Study publicly available on registry

May 6, 2025

Completed
28 days until next milestone

Study Start

First participant enrolled

June 3, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2026

Completed
Last Updated

May 6, 2025

Status Verified

April 1, 2025

Enrollment Period

6 months

First QC Date

April 12, 2025

Last Update Submit

April 27, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Relationship between Lymphocyte-to-CRP ratio and CAD complexity assessed by Syntax score

    To assess the correlation between the lymphocyte-to-C-reactive protein (LCR) ratio and coronary artery disease (CAD) complexity as measured by Syntax score in STEMI and elective PCI patients.

    At baseline during coronary angiography

Secondary Outcomes (1)

  • Association between Lymphocyte-to-CRP ratio and short-term major adverse cardiac events (MACE)

    Within 3 months after PCI

Study Arms (2)

STEMI patients undergoing primary PCI

Description: Patients diagnosed with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI) within 12 hours of symptom onset.

Diagnostic Test: No intervention administered. Standard care will be provided. Blood samples for lymphocyte count and CRP will be collected, and Syntax score will be calculated from angiography.

Elective PCI Patients

Description: Patients undergoing elective coronary angiography and PCI for stable coronary artery disease.

Diagnostic Test: No intervention administered. Standard care will be provided. Blood samples for lymphocyte count and CRP will be collected, and Syntax score will be calculated from angiography.

Interventions

No intervention administered. Standard care will be provided. Blood samples for lymphocyte count and CRP will be collected, and Syntax score will be calculated from angiography.

Elective PCI PatientsSTEMI patients undergoing primary PCI

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample

You may qualify if:

  • Adults aged 18 to 80 years
  • Diagnosed with STEMI undergoing primary PCI within 12 hours of symptom onset
  • Patients undergoing elective PCI with documented coronary artery disease
  • Provided written informed consent

You may not qualify if:

  • Previous history of myocardial infarction, PCI, or coronary artery bypass grafting (CABG)
  • Diagnosed autoimmune or chronic inflammatory disorders
  • Active infection or malignancy at the time of presentation
  • Severe renal impairment (eGFR \<30 mL/min/1.73 m²) or hepatic dysfunction
  • Use of immunosuppressive therapy
  • Diagnosis of acute or chronic leukemia within the past 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Lymphocyte Count

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Leukocyte CountBlood Cell CountCell CountCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHematologic TestsInvestigative TechniquesCell Physiological PhenomenaBlood Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator, Department of cardiology, Assiut University

Study Record Dates

First Submitted

April 12, 2025

First Posted

May 6, 2025

Study Start

June 3, 2025

Primary Completion

December 10, 2025

Study Completion

April 10, 2026

Last Updated

May 6, 2025

Record last verified: 2025-04