Disease Characteristics of Rapidly Progressive Coronary Artery Disease (R-CAD): A Case-control Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 52
- 主要终点
- Elevated ESR or hs-CRP
研究概览
简要总结
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]).
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •Typical symptoms of angina (Canadian Cardiovascular Society [CCS] classification III-IV) and non-invasive evidence of myocardial ischemia; and
- •Occurred within 6 months of the latest ischemia-driven hospitalization and/or coronary revascularization.
- •Rapidly progressive coronary lesions leading to myocardial ischemia:
- •Angiographic evidence of new-onset or worsened coronary de novo or restenotic lesions relevant to myocardial ischemia, and
- •Occurred within 6 months of the latest ischemia-driven coronary angiography and/or revascularization.
- •Control Group (NR-CAD patients):
- •35 to 75 years old*, male or female. (* Based on the age distribution characteristics of patients who have been diagnosed as R-CAD.)
- •Negative results of urine or blood pregnancy test for females with childbearing potential (not post-menopausal or surgically sterile).
- •Currently, at 12±6 months after the latest PCI.
- •Receiving standard treatment for secondary prevention of AS-CAD after the latest PCI.
- •Coronary angiography and/or optical coherence tomography (OCT) performed during the index hospitalization.
- •No evidence of rapidly progressive myocardial ischemia and coronary lesions, i.e., not fulfilling items 5) and 6) of the inclusion criteria for R-CAD.
排除标准
- •Receiving immunosuppressive therapy within 6 months.
- •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 malignancy (diagnosed within 12 months or with ongoing requirement for treatment).
- •Vital organ failure.
- •Life expectancy < 1 year.
- •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.
结局指标
主要结局
Elevated ESR or hs-CRP
时间窗: From 30 days before enrollment up to 14 days after enrollment, but before the initiation of immunosuppressive therapy.
Percentage of patients with elevated ESR (\> 15 mm/h for male or \> 20 mm/h for female) or hs-CRP (≥ 2 mg/L).
次要结局
- Positive autoantibodies(From 30 days before enrollment up to 14 days after enrollment, but before the initiation of immunosuppressive therapy.)
- Established diagnosis of chronic inflammatory diseases(Up to 14 days after enrollment)
- 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(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)
研究者
LiuZhenyu
Professor
Peking Union Medical College Hospital