NCT06007248招募中不适用
Disease Characteristics of Inflammation-associated Rapidly-progressive Coronary Artery Disease (IR-CAD): a Case-control Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Elevated erythrocyte sedimentation rate (ESR)
研究概览
简要总结
The present case-control study is designed to investigate the disease characteristics of IR-CAD by comparing the demographics, clinical features, lab results, imaging findings, and prior treatment between 20 patients with IR-CAD and 10 patients with AS-CAD.
详细描述
A special type of coronary artery disease (CAD) has been identified in the investigators' clinical practice, which has completely different clinical features from those of typical atherosclerotic coronary artery disease (AS-CAD). The patients often have sterile inflammatory diseases and/or clinical evidence of inflammation, whose CAD progresses rapidly, recurs frequently, and responds poorly to intensified secondary prevention of AS-CAD, especially after percutaneous coronary intervention (PCI). The investigators name this special type of CAD with inflammation-associated rapidly-progressive coronary artery disease (IR-CAD). Currently, the overall disease characteristics of IR-CAD remain unknown.
The present case-control study is designed to investigate the disease characteristics of IR-CAD by comparing the demographics, clinical features, lab results, imaging findings, and prior treatment between 20 patients with IR-CAD and 10 patients with AS-CAD.
The first 20 patients who were enrolled in the IR-CAD cohort study, which included patients who met the inclusion/exclusion criteria for IR-CAD and received comprehensive treatment, will be enrolled in the case group of the present IR-CAD case-control study. Patients were diagnosed as IR-CAD if they have 1) evidence of rapidly progressive (occurred within 6 months or occurred on immunosuppressive therapy within 12 months of the last coronary revascularization) myocardial ischemia (typical symptoms and non-invasive evidence) despite standard treatment for secondary prevention of AS-CAD; 2) angiographic evidence of new coronary lesions (de novo stenosis or restenosis) considered to be relevant to myocardial ischemia; 3) evidence of inflammation (positive inflammation markers or established diagnosis of inflammatory diseases or use of immunosuppressive therapy). The comprehensive treatment for IR-CAD included: 1) intensified secondary prevention of AS-CAD; 2) immunosuppressive therapy; 3) coronary revascularization; 4) supportive therapies.
Patients who fulfill the inclusion/exclusion criteria for AS-CAD defined by the protocol of the present case-control study will be enrolled in the control group of the present case-control study. Patients will be diagnoses as AS-CAD if they 1) are ≥ 45 but < 65 years of age; 2) are receiving standard treatment for secondary prevention of AS-CAD after the last PCI which was performed 12±6 months ago; 3) do not have evidence of rapidly progressive (occurred within 6 months or occurred on immunosuppressive therapy within 12 months of the last PCI) myocardial ischemia (typical symptoms and non-invasive evidence); 4) do not have angiographic evidence of new coronary lesions (de novo stenosis or restenosis) considered to be relevant to myocardial ischemia.
Patients in the IR-CAD cohort study underwent examinations after they met the inclusion/exclusion criteria for IR-CAD based on a protocol specifically designed for the clinical management of IR-CAD patients. The results of the above examinations will be used as the examination results of the case group of the present IR-CAD case-control study. While patients in the control group of the present case-control study will undergo similar examinations after enrollment according to the protocol of the present case-control study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 45 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Case group (IR-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 coronary artery bypass graft [CABG]).
- •Receiving standard treatment for secondary prevention of AS-CAD after the last coronary revascularization.
- •Hospitalization due to rapidly-progressive myocardial ischemia:
- •Typical symptoms of angina (Canadian Cardiovascular Society [CCS] III-IV) and non-invasive evidence of myocardial ischemia; and
- •Occurred within 6 months or occurred on immunosuppressive therapy within 12 months of the last coronary revascularization.
- •Angiographic evidence of new coronary lesions (de novo stenosis or restenosis) considered to be relevant to myocardial ischemia.
- •Evidence of inflammation:
- •At least one of the indexes indicating active inflammation has ever been elevated (ESR, high-sensitivity C-reactive protein [hs-CRP], interleukin [IL]-6, tumor necrosis factor [TNF]-α, ferritin, et al); or
- •Established diagnosis of systemic autoimmune disease or systemic vasculitis; or
- •Receiving immunosuppressive therapy.
- •Control group (AS-CAD patients):
- •≥ 45 and < 65 years of age (based on the age distribution of the patients currently enrolled in the IR-CAD cohort study), male or female.
- •Negative results of urine or blood pregnancy test for females with childbearing potential (not post-menopausal or surgically sterile).
- •Currently, 12±6 months after the last PCI.
- •Receiving standard treatment for secondary prevention of AS-CAD after the last PCI.
- •Coronary angiography and/or optical coherence tomography (OCT) performed during the present hospitalization.
- •No evidence of rapidly-progressive myocardial ischemia, which is defined as follows:
- •Typical symptoms of angina (Canadian Cardiovascular Society [CCS] III-IV) and non-invasive evidence of myocardial ischemia; and
- •Occurred within 6 months or occurred on immunosuppressive therapy within 12 months of the last PCI.
- •No angiographic evidence of new coronary lesions (de novo stenosis or restenosis) considered to be relevant to myocardial ischemia.
排除标准
- •Case group (IR-CAD patients):
- •Coronary restenosis due to mechanical factors (stent under-expansion, stent mal-apposition, stent rupture, et al).
- •Other moderate to severe heart diseases (congenital heart disease, valvular heart disease, myocarditis, cardiomyopathy, pericardial diseases, pulmonary hypertension, heart failure, arrhythmia, et al).
- •Active acute or chronic infection (human immunodeficiency virus [HIV], tuberculosis, et al).
- •Active malignancy (diagnosed within 12 months or with ongoing requirement for treatment).
- •Vital organ failure.
- •Life expectancy < 1 year.
- •Contraindications for or intolerance to treatment for secondary prevention of AS-CAD, contrast agents, glucocorticoids, immunosuppressive agents.
- •In pregnancy or breast-feeding, or with intention to be pregnant during the study period.
- •Risk of non-compliance (history of drug addiction or alcohol abuse, et al).
- •Previous enrollment in this study.
- •Participation in another study within 30 days.
- •Involvement in the planning and conduct of this study (applying to investigators, contract research organization staffs, study site staffs, et al).
- •Any condition, which in the opinion of the investigators, would make it unsuitable for the patient to participate in this study.
- •Control group (AS-CAD patients):
- •The same as those for the case group (IR-CAD patients).
结局指标
主要结局
Elevated erythrocyte sedimentation rate (ESR)
时间窗: From the last coronary revascularization up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.
Percentage of patients with elevated ESR (\> 15 mm for male or \> 20 mm for female). In case of normal ESR, prior use of immunosuppressive therapy or prior diagnosis of autoimmune diseases before enrollment is regarded as the equivalent to elevated ESR.
次要结局
- Body weight(On the day of enrollment.)
- Female sex(On the day of enrollment.)
- Acute coronary syndrome (ACS)(On the day of enrollment.)
- Smoking(On the day of enrollment.)
- Old myocardial infarction (OMI)(On the day of enrollment.)
- Coronary artery bypass graft (CABG)(On the day of enrollment.)
- Blood pressure(On the day of enrollment.)
- Heart rate(On the day of enrollment.)
- Antithrombotic agents(On the day of enrollment.)
- White blood cell(From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.)
- Total bilirubin (T-Bil)(From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.)
- Thyroxine (T4)(From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.)
- Free triiodothyronine (FT3)(From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.)
- Total cholesterol (TC)(From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.)
- Hemoglobin A1c (HbA1c).(From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.)
- Cardiac troponin I (cTnI)(From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.)
- Antiphospholipid antibody(From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.)
- Protein S(From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.)
- Anti-thrombin III(From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.)
- Anti-nuclear antibody (ANA)(From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.)
- Creatine kinase (CK)(From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.)
- Age(On the day of enrollment.)
- Yellow race(On the day of enrollment.)
- Hypertension(On the day of enrollment.)
- Number of prior coronary revascularization(On the day of enrollment.)
- Hypoglycemic agents(On the day of enrollment.)
- Target vessel related major adverse cardiovascular events (TV-MACE)(From the last coronary revascularization up to the day of enrollment.)
- Aspartate aminotransferase (AST)(From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.)
- Blood urea nitrogen (BUN)(From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.)
- High-density lipoprotein cholesterol (HDL-C)(From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.)
- Lipoprotein (a) (Lp[a])(From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.)
- Fasting blood glucose (FBG)(From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.)
- Creatine kinase-myocardial band (CK-MB)(From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.)
- Dyslipidemia(On the day of enrollment.)
- Percutaneous coronary intervention (PCI)(On the day of enrollment.)
- Height(On the day of enrollment.)
- Blood pressure-lowering agents(On the day of enrollment.)
- Lipid-lowering agents(On the day of enrollment.)
- Other immunosuppressive therapy(On the day of enrollment.)
- Major adverse cardiovascular events (MACE)(From the last coronary revascularization up to the day of enrollment.)
- Red blood cell(From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.)
- Lactate dehydrogenase (LDH)(From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.)
- Albumin(From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.)
- Triiodothyronine (T3)(From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.)
- Diabetes(On the day of enrollment.)
- β-blockers(On the day of enrollment.)
- Chronic coronary syndrome (CCS).(On the day of enrollment.)
- Body mass index (BMI)(On the day of enrollment.)
- Glucocorticoids(On the day of enrollment.)
- Immunosuppressive agents(On the day of enrollment.)
- Alkaline phosphatase (ALP)(From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.)
- Direct bilirubin (D-Bil)(From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.)
- Low-density lipoprotein cholesterol (LDL-C)(From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.)
- Triglyceride (TG)(From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.)
- Apolipoprotein A (ApoA)(From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.)
- N-terminal pro-B-type natriuretic peptide (NT-proBNP).(From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.)
- Anti-phosphatidylserine antibody(From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.)
- Protein C(From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.)
- Anti-neutrophil cytoplasmic antibody (ANCA)(From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.)
- Anti-cyclic citrullinated peptide (Anti-CCP)(From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.)
- Interleukin (IL)-6(From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.)
- Pathological Q waves(From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.)
- Carotid artery stenosis(From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.)
- Lower extremity artery stenosis(From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.)
- Number of vessel segments with coronary lesions.(From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.)
- Free thyroxine (FT4)(From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.)
- Hemoglobin(From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.)
- Platelet(From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.)
- Alanine aminotransferase (ALT)(From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.)
- Gamma-glutamyl transferase (GGT)(From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.)
- Creatinine(From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.)
- Thyroid-stimulating hormone (TSH)(From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.)
- Lupus anticoagulant(From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.)
- Anti-prothrombin antibody(From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.)
- Rheumatoid factor (RF)(From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.)
- High-sensitivity C-reactive protein (hs-CRP)(From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.)
- Segmental wall motion abnormality(From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.)
- Birmingham Vasculitis Activity Score (BVAS)(From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.)
- Number of squats in 1 minute(From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.)
- Upper extremity artery stenosis(From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.)
- Apolipoprotein B (ApoB)(From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.)
- B-type natriuretic peptide (BNP)(From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.)
- Immunoglobulin(From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.)
- Erythrocyte sedimentation rate (ESR)(From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.)
- Tumor necrosis factor (TNF)-α.(From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.)
- Dynamic ST-T changes(From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.)
- Left ventricular end-systolic diameter (LVESD)(From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.)
- Subclavian artery stenosis(From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.)
- Iliac artery stenosis(From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.)
- Abdominal aorta stenosis(From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.)
- Renal artery stenosis(From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.)
- Target lesion percent area stenosis (TL-%AS)(From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.)
- Activated protein C resistance (APC-R)(From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.)
- Maximum platelet aggregation (MPA)(From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.)
- Anti-endothelial cell antibody (AECA)(From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.)
- Complement(From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.)
- Left atrial diameter (LAD)(From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.)
- Walking distance in 6 minutes(From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.)
- Temporal artery stenosis(From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.)
- Celiac trunk stenosis(From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.)
- Target lesion minimal lumen area (TL-MLA)(From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.)
- Left ventricular end-diastolic diameter (LVEDD)(From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.)
- Left ventricular ejection fraction (LVEF)(From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.)
- Vertebral artery stenosis(From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.)
- Superior mesenteric artery stenosis(From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.)
- SYNTAX score(From the index hospital admission up to 2 weeks of enrollment, but before the initiation of comprehensive treatment for patients with IR-CAD.)
研究者
LiuZhenyu
Professor
Peking Union Medical College Hospital
研究点 (1)
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