An observational study in Coronary Artery Disease, Coronary Artery Disease Progression and Coronary Artery Stenosis, sponsored by Peking Union Medical College Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-19.
Sponsored by Peking Union Medical College Hospital · Observational
This is a cohort study to investigate the clinical features, current treatment and clinical outcomes in patients with inflammation-associated non-rapidly-progressive coronary artery disease (INR-CAD).
A special type of coronary artery disease (CAD) has been identified in our clinical practice. The patients have significantly different clinical features from those of typical atherosclerotic coronary artery disease (AS-CAD), including: 1) predominantly female; 2) early onset CAD; 3) lack of traditional atherosclerotic risk factors; 4) often with evidence of chronic inflammation; 5) responding poorly to intensified secondary prevention and optimized coronary revascularization (percutaneous coronary intervention [PCI] or coronary bypass graft [CABG]); 6) delayed disease progression on immunosuppressive therapy. This special type of CAD is named with inflammation-associated coronary artery disease (I-CAD). Currently, the pathogenesis as well as the optimal approach regarding the diagnosis and treatment of I-CAD remain unknown.
Based on the rate of disease progression and the urgency for clinical management, I-CAD is classified into two categories: 1) inflammation-associated rapidly-progressive coronary artery disease (IR-CAD), which is defined as I-CAD with progression of coronary de novo and/or restenotic lesions within 6 months or within 12 months (only for patients receiving immunosuppressive therapy within 24 months); 2) inflammation-associated non-rapidly-progressive coronary artery disease (INR-CAD), which is defined as I-CAD not fulfilling the criteria for IR-CAD.
It has been recognized in our clinical practice that INR-CAD is a highly heterogeneous group of diseases. Therefore, the present observational cohort study was designed to investigate the clinical features, current treatment and clinical outcomes in patients with INR-CAD.
All patients who have been admitted to the Department of Cardiology, Peking Union Medical College Hospital (PUMCH) since January 1, 2022 will be screened for study participation. Clinical diagnostic criteria and a clinical follow-up protocol have been specifically designed for INR-CAD in our center. Patients are clinically diagnosed as INR-CAD if they 1) have angiographic evidence of coronary lesions (de novo or restenotic); 2) have evidence of chronic inflammation (positive inflammatory markers or positive autoantibodies or established diagnosis of chronic inflammatory diseases or use of immunosuppressive therapy) within 24 months; 3) not meet the clinical diagnostic criteria for IR-CAD. Once the clinical diagnosis is established, INR-CAD patients will receive a 24-month clinical follow-up according to the clinical follow-up protocol for INR-CAD in PUMCH. Patients who have been clinically diagnosed as INR-CAD and received, or are receiving, or will receive the 24-month clinical follow-up will be enrolled in the present cohort study.
The primary efficacy endpoint is major adverse cardiovascular events (MACE). The secondary efficacy endpoints include the individual components of MACE, exercise capacity, angiographic metrics of coronary lesions, and inflammatory markers. The safety endpoints are major bleeding events and severe infection events.
For the endpoints which are categorical variables, e.g., MACE, the event rate for the first occurrence of each endpoint during the 24-month clinical follow-up will be calculated. Chi-square test or Fisher's exact test will be used to compare the event rate for each endpoint between patients with different diagnosis and/or those receiving different treatment, including patients 1) with vs. without established diagnosis of chronic inflammatory diseases; 2) receiving vs. not receiving immunosuppressive therapy; 3) receiving vs. not receiving coronary revascularization.
For the endpoints which are continuous variables, e.g., inflammatory markers, 1) paired t-test or paired rank sum test will be used to compare the level of each endpoint at the end of the 24-month clinical follow-up with that at baseline (the diagnosis of INR-CAD); 2) analysis of co-variance (ANCOVA) will be used to compare the level of each endpoint at the end of the 24-month clinical follow-up between patients with different diagnosis and/or those receiving different treatment, including patients ① with vs. without established diagnosis of chronic inflammatory diseases; ② receiving vs. not receiving immunosuppressive therapy; ③ receiving vs. not receiving coronary revascularization.
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's planned enrollment of 120 is below the median of 336 across 1,947 observational studies indexed under Coronary Artery Disease.
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All patients who have been admitted to the Department of Cardiology, Peking Union Medical College Hospital (PUMCH) since January 1, 2022 will be screened for study participation.
Exclusion Criteria:
Patients who have been clinically diagnosed as INR-CAD and received, or are receiving, or will receive the 24-month clinical follow-up according to the clinical diagnostic criteria and follow-up protocol for INR-CAD.
Behavioral: Healthy life style · Drug: Secondary prevention for atherosclerotic coronary artery disease · Drug: Immunosuppressive Therapy · Procedure: Coronary revascularization · Drug: Supportive therapies
Healthy diet, regular exercise, and quitting smoking
Antiplatelet therapy, as well as medications for control of heart rate, blood pressure, low-density lipoprotein cholesterol, and blood glucose
Glucocorticoids and/or immunosuppressive agents
Percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG).
Medical interventions for prevention and treatment of the side effects of the above treatment, such as abnormal liver function, hypocalcemia, hypokalemia, peptic ulcer, infection, et al.
Major adverse cardiovascular events (MACE)
The composite endpoint including death, or Q-wave myocardial infarction, or unplanned myocardial ischemia-driven coronary revascularization (PCI or CABG), or unplanned myocardial ischemia-driven hospitalization.
Time frame: From the beginning (diagnosis of INR-CAD) to the end of the 24-month clinical follow-up.
Death
All-cause death.
Time frame: From the beginning (diagnosis of INR-CAD) to the end of the 24-month clinical follow-up.
Q-wave myocardial infarction
Myocardial injury due to myocardial ischemia, resulting in newly formed pathological Q waves in ≥ 2 contiguous leads or equivalent manifestations on electrocardiogram.
Time frame: From the beginning (diagnosis of INR-CAD) to the end of the 24-month clinical follow-up.
Unplanned myocardial ischemia-driven coronary revascularization
Unplanned coronary revascularization (PCI or CABG) due to myocardial ischemia.
Time frame: From the beginning (diagnosis of INR-CAD) to the end of the 24-month clinical follow-up.
Unplanned myocardial ischemia-driven hospitalization
Unplanned hospitalization due to myocardial ischemia.
Time frame: From the beginning (diagnosis of INR-CAD) to the end of the 24-month clinical follow-up.
Walking distance in 6 minutes
The result of 6-minute walk test (6MWT).
Time frame: At the beginning (diagnosis of INR-CAD) and the end of the 24-month clinical follow-up.
Target lesion minimal lumen area (TL-MLA)
The minimum lumen area of the target lesion on optical coherence tomography (OCT).
Time frame: At the beginning (diagnosis of INR-CAD) and the end of the 24-month clinical follow-up.
Target lesion percent area stenosis (TL-%AS)
Percent area stenosis (% AS) = { \[ ( proximal RLA + distal RLA ) - (MLA × 2) \] / ( proximal RLA + distal RLA ) } × 100% in the cross-section with the MLA of the target lesion on optical coherence tomography (OCT). RLA = reference lumen area; MLA = minimum lumen area; % AS = percent area stenosis.
Time frame: At the beginning (diagnosis of INR-CAD) and the end of the 24-month clinical follow-up.
SYNTAX score
The result of SYNTAX score calculation.
Time frame: At the beginning (diagnosis of INR-CAD) and the end of the 24-month clinical follow-up.
Number of vessel segments with coronary lesions
Number of vessel segments with diameter stenosis ≥ 50% on coronary angiogram.
Time frame: At the beginning (diagnosis of INR-CAD) and the end of the 24-month clinical follow-up.
Erythrocyte sedimentation rate (ESR)
The result of erythrocyte sedimentation rate (ESR) test.
Time frame: At the beginning (diagnosis of INR-CAD) and the end of the 24-month clinical follow-up.
High-sensitivity C-reactive protein (hs-CRP)
The result of serum high-sensitivity C-reactive protein (hs-CRP) test.
Time frame: At the beginning (diagnosis of INR-CAD) and the end of the 24-month clinical follow-up.
Interleukin-6 (IL-6)
The result of serum interleukin (IL)-6 test.
Time frame: At the beginning (diagnosis of INR-CAD) and the end of the 24-month clinical follow-up.
Tumor necrosis factor-alpha (TNF-α)
The result of serum tumor necrosis factor-alpha (TNF-α) test.
Time frame: At the beginning (diagnosis of INR-CAD) and the end of the 24-month clinical follow-up.
Major bleeding events
Major bleeding events evaluated according to the Bleeding Academic Research Consortium (BARC) criteria.
Time frame: From the beginning (diagnosis of INR-CAD) to the end of the 24-month clinical follow-up.
Severe infection events
Infection events involving vital organs, or with complications (such as structural change and/or dysfunction of vital organs, septic shock, et al), or requiring hospitalization, or requiring treatment with intravenous antibiotics, or requiring treatment with interventional procedures or surgeries.
Time frame: From the beginning (diagnosis of INR-CAD) to the end of the 24-month clinical follow-up.
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