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The present case-control study is designed to investigate the disease characteristics of rapidly progressive coronary artery disease (R-CAD) by comparing the demographics, clinical features, lab results, imaging findings, and prior treatment between patients in the case group (approximately 34 patients with R-CAD) and those in the control group (approximately 18 patients with non-rapidly progressive coronary artery disease [NR-CAD]).
The majority of coronary artery disease (CAD) is atherosclerotic coronary artery disease (AS-CAD), the pathological basis of which is atherosclerosis. Secondary prevention, including healthy life style and medical treatment, effectively controls the progression of AS-CAD. Coronary revascularization, including percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG) are the dominant treatment modalities to restore the patency and/or blood flow of the diseased coronary arteries.
A special type of CAD is identified in the investigators' clinical practice, which progresses rapidly and recurs frequently after PCI or CABG, and responds poorly to intensified secondary prevention for AS-CAD. The investigators name this special type of CAD with rapidly progressive coronary artery disease (R-CAD), which has significantly different clinical features from those of typical AS-CAD. The CAD without the above characteristics is named with non-rapidly progressive coronary artery disease (NR-CAD).
Currently, the disease characteristics of R-CAD remain unknown. It has been identified that a proportion of R-CAD patients demonstrate certain manifestations of inflammation, including positive inflammatory markers, or positive autoantibodies, or established diagnosis of chronic inflammatory diseases, or use of immunosuppressive therapy, whose R-CAD is named as inflammation-associated rapidly progressive coronary artery disease (IR-CAD). However, the rest of R-CAD patients demonstrate no manifestations of inflammation. Therefore, the present case-control study is designed to investigate the disease characteristics of the overall R-CAD patients by comparing the demographics, clinical features, lab results, imaging findings, and prior treatment between the case group (approximately 34 patients with R-CAD) and the control group (approximately 18 patients with NR-CAD).
Patients will be enrolled in the case group (R-CAD patients) of the present case-control study if they 1) have prior history of coronary revascularization (PCI or CABG); 2) received standard treatment for secondary prevention of AS-CAD after the latest coronary revascularization; 3) have evidence of rapidly progressive myocardial ischemia leading to hospitalization and/or coronary revascularization; 4) have angiographic evidence of rapidly progressive coronary lesions leading to myocardial ischemia.
Patients will be enrolled in the control group (NR-CAD patients) of the present case-control study if they 1) are 35 to 75 years old; 2) received standard treatment for secondary prevention of AS-CAD after the latest PCI which was performed 12±6 months ago; 3) do not have evidence of rapidly progressive myocardial ischemia leading to hospitalization and/or coronary revascularization; 4) do not have angiographic evidence of rapidly progressive coronary lesions leading to myocardial ischemia.
Once enrolled, patients in both groups will receive examinations and evaluations according to a clinical management protocol specifically designed for the clinical management of R-CAD patients. The information regarding the baseline characteristics and the results of examinations and evaluations, including demographics, clinical features, lab results, imaging findings, and prior treatment, will be collected and compared between the case group and the control group.
The primary endpoint is the rate of elevated erythrocyte sedimentation rate (ESR) or high-sensitivity C-reactive protein (hs-CRP).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Case Group | R-CAD patients |
| |
| Control Group | NR-CAD patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Protocol-defined Examinations and Evaluations | Diagnostic Test | Lab tests (blood and urine and stool routine tests, hepatic and renal and thyroid function tests, tests for metabolic markers, tests for cardiac biomarkers, thrombosis-related tests, rheumatology tests, tests for inflammation markers), electrocardiography, echocardiography, 6-minute walk test, vascular ultrasound, coronary angiography, optical coherence tomography (OCT), fibroblast activation protein inhibitor positron emission tomography/computed tomography (FAPI-PET/CT), photon-counting detector coronary computed tomography angiography (PCD-CCTA), tests for exploratory biomarkers. |
| Measure | Description | Time Frame |
|---|---|---|
| Elevated ESR or hs-CRP | Percentage of patients with elevated ESR (> 15 mm/h for male or > 20 mm/h for female) or hs-CRP (≥ 2 mg/L). | From 30 days before enrollment up to 14 days after enrollment, but before the initiation of immunosuppressive therapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Positive autoantibodies | Percentage of patients with positive autoantibodies (anti-nuclear antibody [ANA], anti-neutrophil cytoplasmic antibody [ANCA], anti-endothelial cell antibody [AECA], lupus anticoagulant [LA], antiphospholipid antibody (APL) (anti-cardiolipin antibody [ACL], anti-beta2-glycoprotein 1 antibody [abeta2GP1]), anti-phosphatidylserine antibody [APSA], rheumatoid factor [RF], anti-cyclic citrullinated peptide antibody [anti-CCP], et al.). |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum standardized uptake value (SUVmax) | SUVmax based on fibroblast activation protein inhibitor positron emission tomography/computed tomography (FAPI-PET/CT). | From 30 days before enrollment up to 14 days after enrollment, but before the initiation of immunosuppressive therapy. |
| Maximum target background ratio (TBRmax) |
Inclusion Criteria:
Case Group (R-CAD patients):
18 years of age or older, male or female.
Negative results of urine or blood pregnancy test for females with childbearing potential (not post-menopausal or surgically sterile).
Prior history of coronary revascularization (PCI or CABG).
Receiving standard treatment for secondary prevention of AS-CAD after the latest coronary revascularization.
Rapidly progressive myocardial ischemia leading to hospitalization and/or coronary revascularization:
Rapidly progressive coronary lesions leading to myocardial ischemia:
Control Group (NR-CAD patients):
Exclusion Criteria:
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Patients who fulfill the inclusion/exclusion criteria for R-CAD defined by the protocol of the present case-control study will be enrolled in the case group of the present case-control study.
Patients who fulfill the inclusion/exclusion criteria for NR-CAD defined by the protocol of the present case-control study will be enrolled in the control group of the present case-control study.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhenyu Liu, M.D. | Contact | +861069155068 | Pumch_lzy@163.com | |
| Lihong Xu, B.N. | Contact | +861069155068 | xulihong1990@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhenyu Liu, M.D. | Peking Union Medical College Hospital | Principal Investigator |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D023921 | Coronary Stenosis |
| D023903 | Coronary Restenosis |
| D018450 | Disease Progression |
| D020969 | Disease Attributes |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D010808 | Physical Examination |
| ID | Term |
|---|---|
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Blood samples will be retained for exploratory tests, including RNA sequencing, proteomics, and metabolomics, et al.
|
| From 30 days before enrollment up to 14 days after enrollment, but before the initiation of immunosuppressive therapy. |
| Established diagnosis of chronic inflammatory diseases | Percentage of patients with established diagnosis of chronic inflammatory diseases (chronic infectious disease, autoimmune disease, other chronic inflammatory diseases, et al.). | Up to 14 days after enrollment |
| Elevated ESR or hs-CRP, or positive autoantibodies | Percentage of patients with elevated ESR or hs-CRP, or positive autoantibodies. | From 30 days before enrollment up to 14 days after enrollment, but before the initiation of immunosuppressive therapy. |
| Elevated ESR or hs-CRP, or positive autoantibodies, or established diagnosis of chronic inflammatory diseases | Percentage of patients with elevated ESR or hs-CRP, or positive autoantibodies, or established diagnosis of chronic inflammatory diseases. | For elevated ESR or hs-CRP and positive autoantibodies: from 30 days before enrollment up to 14 days after enrollment, but before the initiation of immunosuppressive therapy; for established diagnosis of chronic inflammatory diseases: up to 14 days after |
TBRmax based on fibroblast activation protein inhibitor positron emission tomography/computed tomography (FAPI-PET/CT). |
| From 30 days before enrollment up to 14 days after enrollment, but before the initiation of immunosuppressive therapy. |
| Fat attenuation index (FAI) | FAI based on photon-counting detector coronary computed tomography angiography (PCD-CCTA). | From 30 days before enrollment up to 14 days after enrollment, but before the initiation of immunosuppressive therapy. |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |