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.
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 :
- 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).
- 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 .
- Conditions
- Coronary Artery Disease
- 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 group | Role | What they receive |
|---|---|---|
| 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. 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 Patients | Description: 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.
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)
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.
- First posted6 May 2025
- Study start3 Jun 2025 (estimated)
- Primary completion10 Dec 2025 (estimated)
- Study completion10 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alsayed Ali Mahmoud Ahmed, Assiut University
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
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relation Between Lymphocyte-to-C-Reactive Protein Ratio and Coronary Artery Disease Complexity
- ClinicalTrials.gov ID
- NCT06958562
- Acronym / sponsor ID
- LCR ratio and CAD complexity
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 3 Jun 2025 (estimated)
- Primary completion
- 10 Dec 2025 (estimated)
- Study completion
- 10 Apr 2026 (estimated)
- First posted
- 6 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aim(s) of the Research :
- 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).
- 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.
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 .
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STEMI patients undergoing primary PCI | – | 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.Description: Patients diagnosed with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI) within 12 hours of symptom onset. |
| Elective PCI Patients | – | 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.Description: Patients undergoing elective coronary angiography and PCI for stable coronary artery disease. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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.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 | Elective PCI Patients, STEMI patients undergoing primary PCI |
Primary outcome
Relationship between Lymphocyte-to-CRP ratio and CAD complexity assessed by Syntax score
Time frame: At baseline during coronary angiography
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.
1 secondary outcome
Association between Lymphocyte-to-CRP ratio and short-term major adverse cardiac events (MACE)
Time frame: Within 3 months after PCI
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
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.