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Coronary Artery DiseaseNCT06958562

Relation Between Lymphocyte-to-C-Reactive Protein Ratio and Coronary Artery Disease Complexity

An observational study of Coronary Artery Disease, run by Assiut University.

Not yet recruiting

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

Official record
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Trial summary

Aim(s) of the Research : 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Coronary Artery Disease
How many people
600 participants
Where
No sites listed yet
Study dates
3 Jun 2025to 10 Apr 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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

About this study

Aim(s) of the Research :

  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. 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.
Read the detailed description

Cardiovascular diseases (CVD) remain the leading cause of mortality globally, responsible for approximately 17.9 million deaths annually, with over 75% occurring in low- and middle-income countries . Coronary artery disease (CAD is the leading contributor to cardiovascular-related deaths. It accounts for 45% of total fatalities linked to cardiovascular conditions .

ST-segment elevation myocardial infarction (STEMI), a severe manifestation of coronary artery disease (CAD), is a medical emergency requiring immediate revascularization to prevent irreversible myocardial damage and reduce mortality .

Primary percutaneous coronary intervention (PCI) is the preferred reperfusion strategy for STEMI, significantly reducing mortality and major adverse cardiovascular events (MACE) compared to fibrinolysis . The complexity of coronary lesions during PCI is quantified using the Syntax score, an angiographic tool that predicts procedural success and long-term outcomes . A higher Syntax score indicates increased lesion complexity, worse prognosis, and a greater risk of complications, including arrhythmias, cardiogenic shock, and heart failure .

Vascular inflammation is a key factor in the onset, progression, plaque instability, and eventual rupture of atherosclerosis . As a result, numerous inflammatory biomarkers have gained significant interest.

The inflammatory process begins with the infiltration of inflammatory cells and plays a central role in atherosclerosis, starting from its earliest stages. As atherosclerosis progresses, inflammation has been strongly associated with strokes and acute myocardial infarctions (MI) .

Systemic inflammation plays a pivotal role in the pathophysiology of atherosclerosis and its complications . Inflammatory markers, such as elevated C-reactive protein (CRP), have been shown to predict adverse outcomes in CAD . Concurrently, lymphopenia is a marker of immune suppression and poor cardiovascular prognosis .

C-reactive protein (CRP) is a well-established marker of inflammation commonly used to monitor infections and inflammatory disorders. Lymphocytes, as key players in the immune response, tend to decrease in number during excessive immune activation . In clinical practice, markers such as leukocytes, neutrophils, lymphocytes, platelets, and CRP are routinely measured as indicators of inflammation. Combining these biomarkers may provide greater reliability and diagnostic accuracy than relying on a single marker alone.

The lymphocyte-to-CRP (LCR) ratio, which combines these two markers, has emerged as a promising biomarker for risk stratification in acute coronary syndromes .

The C-reactive protein-to-lymphocyte ratio (CLR) has emerged as a novel inflammatory biomarker, offering potential for predicting prognosis and aiding in the diagnostic evaluation of various conditions. For instance, elevated CLR levels have been associated with poor outcomes in COVID-19 patients , as well as in those with severe fever and thrombocytopenia syndrome . Additionally, high CLR levels have been linked to unfavorable prognoses in patients with malignant diseases . Despite this growing evidence, the relationship between CLR and MI remains underexplored.

Preliminary studies suggest that a lower LCR ratio is associated with increased CAD severity and poorer outcomes . However, the relationship between LCR ratio and Syntax score, particularly in STEMI patients undergoing primary PCI, remains underexplored. Similarly, its relevance in elective PCI, where lesion complexity and systemic inflammation may differ, has not been fully investigated.

While both Syntax score and LCR ratio provide valuable prognostic information, there is limited evidence on their interplay and predictive value for short-term outcomes in STEMI and elective PCI patients. By addressing this gap, this study aims to improve risk stratification and clinical decision-making .

Being tested
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.
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.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.

Study groups in NCT06958562
Study groupRoleWhat they receive
STEMI patients undergoing primary PCIDescription: Patients diagnosed with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI) within 12 hours of symptom onset.
Receives: 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 PatientsDescription: Patients undergoing elective coronary angiography and PCI for stable coronary artery disease.
Receives: 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: At baseline during coronary angiography

Secondary outcomes (1)
  1. Association between Lymphocyte-to-CRP ratio and short-term major adverse cardiac events (MACE)

    To evaluate the association between the LCR ratio and the incidence of major adverse cardiac events (MACE) within 6 months in patients undergoing primary PCI.

    Measured: Within 3 months after PCI

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2025
  2. Study start3 Jun 2025 (estimated)
  3. Primary completion10 Dec 2025 (estimated)
  4. Study completion10 Apr 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
Other
Time perspective
Prospective
Enrolment
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06958562
Sponsor's protocol ID
LCR ratio and CAD complexity
Status last verified
Apr 2025
First submitted
12 Apr 2025
Last updated
6 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease, 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 6 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 6 May 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Relationship between Lymphocyte-to-CRP ratio and CAD complexity assessed by Syntax score (time frame: At baseline during coronary angiography). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 6 May 2025.

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