Coronary Computed Tomography Angiography In Rheumatoid Arthritis Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 4,000
- 试验地点
- 4
- 主要终点
- Number of participants with all-cause death (all-cause mortality)
研究概览
简要总结
The Coronary Computed Tomography Angiography in Rheumatoid Arthritis study is part of the multinational, prospective, observational Autoimmunity and Atherosclerosis in Rheumatic Diseases cohort (https://atacc-rd.com) that includes comprehensive baseline and follow-up assessments at 3, 5, and 10 years. It comprises a main protocol and several optional modules, including a Cardiac Imaging Module, Biobanking Module, Pulmonary Module, and Anxiety and Depression Module.
The study aims to advance understanding of cardiopulmonary and psychological comorbidities in rheumatoid arthritis, to improve early identification and management, and to enhance insights into underlying disease mechanisms-ultimately refining risk stratification and targeted prevention strategies.
The study includes 4,000 patients with rheumatoid arthritis enrolled through the Cardiac Imaging Module in the main protocol. Participants undergo coronary computed tomography angiography, pulmonary function testing, physical examination, questionnaires, and biobanking, supplemented by genetic, proteomic, metabolomic, and microbiome profiling.
详细描述
This prospective, observational study follows individuals with rheumatoid arthritis over time to understand how the disease and its treatment relate to cardiovascular, pulmonary, psychological, and biological outcomes. The study collects standardized clinical data from outpatient rheumatology clinics, complemented by advanced imaging, biological sample collection, and linkage to national health registries.
Study Procedures and Visit Schedule Participants are enrolled during routine or ad-hoc outpatient visits. After informed consent, a baseline evaluation is performed, followed by standardized follow-up visits after approximately 3, 5, and 10 years (± 3-6 months).
At baseline, demographic and lifestyle factors (age, sex, education, smoking, alcohol, physical activity, and family history) are recorded together with anthropometric measures (height, weight, waist circumference) and rheumatoid arthritis characteristics (serologic status, disease duration, erosive disease, and disease activity scores). Concomitant diseases and medications are documented, and vital signs and blood pressure are measured.
Patient-reported outcomes include validated questionnaires on quality of life (Short Form 36, version 1), functional ability (Multidimensional Health Assessment Questionnaire), work productivity (Work Productivity and Activity Impairment - General Health), fatigue and pain visual analogue scales, physical activity (International Physical Activity Questionnaire - Short Form), and shortness of breath (University of California, San Diego Shortness of Breath Questionnaire). Laboratory results, including markers of inflammation and metabolic status, are obtained according to routine standards.
Follow-up visits repeat these assessments to evaluate disease activity, lifestyle changes, and incident comorbidities. Events such as hospitalizations, procedures, and deaths are continuously updated through registry linkage, ensuring complete longitudinal follow-up.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fulfill the ACR/EULAR-2010 criteria for rheumatoid arthritis
- •Attending or has attended at least one visit during the last two years in rheumatology outpatient clinic for diagnostic or monitoring purposes related to rheumatoid arthritis
- •Age 50-75 years
排除标准
- •Diagnosed with overlapping systemic autoimmune diseases other than secondary Sjogren's syndrome
- •Active cancer
- •Prior coronary atherosclerotic symptoms as defined by myocardial infraction, percutaneous coronary intervention, or coronary artery bypass grafting
- •Allergy to radiocontrast agents
- •Estimated glomerular filtration rate (eGFR) < 30 mL/min
- •BMI > 35 kg/m2
- •Persistent atrial fibrillation
结局指标
主要结局
Number of participants with all-cause death (all-cause mortality)
时间窗: 3, 5 and 10 years
Death from any cause
Number of participants with a first occurrence of Major Adverse Cardiovascular Events (MACE)
时间窗: 3, 5 and 10 years
1. Cardiovascular death as defined by death from any of the following causes: Ischemic heart disease; Sudden cardiac death; Ventricular tachycardia; Other cardiac arrhythmias; Heart failure; Fatal ischemic stroke; Sudden undefined death; Unwitnessed or unknown cause of death 2. Hospitalization for non-fatal myocardial infarction, including hospitalization for PCI and CABG 3. Hospitalization for non-fatal ischemic stroke
Number of participants with a first occurrence of any ischemic cardiovascular events, including MACE
时间窗: 3, 5 and 10 years
Hospitalization for cerebrovascular disease (transient ischemic attack). Hospitalization for peripheral vascular disease. Hospitalization for peripheral vascular surgery. Cardiovascular death as defined by death from any of the following causes: Ischemic heart disease; Sudden cardiac death; Ventricular tachycardia; Other cardiac arrhythmias; Heart failure; Fatal ischemic stroke; Sudden undefined death; Unwitnessed or unknown cause of death. Hospitalization for non-fatal myocardial infarction, including hospitalization for PCI and CABG. Hospitalization for non-fatal ischemic stroke
次要结局
- Coronary Artery Calcium Score (Agatston score)(Baseline)
- The coronary artery plaque surface extent at baseline evaluated for the percent composition of non-calcified-, mixed-, and calcified plaques(Baseline)
- Change in Coronary Artery Calcium Score (Agatston units) from baseline to 3 years(Baseline and 3 years)
- The quantitative difference in coronary artery plaque surface extent from baseline to 3 years evaluated for the percent composition of non-calcified-, mixed-, and calcified plaques(Baseline and 3 year)
- Number of participants with a occurrence of hospitalization for cerebrovascular disease(3, 5 and 10 years)
- Number of participants with a first occurrence of hospitalization for non-fatal myocardial infarction(3, 5 and 10 years)
- Number of participants with a occurrence of hospitalization for non-fatal ischemic stroke(3, 5 and 10 years)
- Number of participants with a occurrence of hospitalization for peripheral vascular disease(3, 5 and 10 years)
- Number of participants with a occurrence of hospitalization for peripheral vascular surgery(3, 5 and 10 years)
- Number of participants with a occurrence of hospitalization for thromboembolic events as defined by deep vein thrombosis and pulmonary embolism(3, 5 and 10 years)
- Number of participants with a first occurrence of hospitalization for PCI(3, 5 and 10 years)
- Number of participants with a first occurrence of hospitalization for CABG(3, 5 and 10 years)
- Number of participants with a first occurrence of treatment for stable angina pectoris(3, 5 and 10 years)
- Number of participants with a occurrence of treatment for atrial fibrillation and flutter(3, 5 and 10 years)
- Number of participants with sudden death(3, 5 and 10 years)
- Number of participants with cardiovascular death(3, 5 and 10 years)
- Number of participants with a occurrence of treatment for essential hypertension with/without complications(3, 5 and 10 years)
- Number of participants with a occurrence of treatment for disorders of lipoprotein metabolism and other lipidemias(3, 5 and 10 years)
- Number of participants with a occurrence of treatment for diabetes mellitus(3, 5 and 10 years)
- Number of participants with a occurrence of hospitalization for respiratory disease(3, 5 and 10 years)
- Number of participants with a occurrence of hospitalization or specialist-initiated treatment for interstitial pulmonary diseases(3, 5 and 10 years)
- Number of participants with a occurrence of hospitalization or specialist-initiated treatment for chronic lower respiratory diseases(3, 5 and 10 years)
- Number of participants with a occurrence of hospitalization or specialist-initiated treatment for anxiety disorders, including generalized anxiety disorder(3, 5 and 10 years)
- Number of participants with a occurrence of hospitalization or specialist-initiated treatment for a depressive episode or recurrent major depressive disorder(3, 5 and 10 years)
- Number of participants with a occurrence of general practitioner-initiated treatment for anxiety disorders(3, 5 and 10 years)
- Number of participants with a occurrence of general practitioner-initiated treatment for depression(3, 5 and 10 years)
- Number of participants with a occurrence of referral to a psychologist or psychiatrist(3, 5 and 10 years)
- Number of participants with a occurrence of infection with Mycobacterium tuberculosis(3, 5 and 10 years)
- Number of participants with a occurrence of opportunistic infections(3, 5 and 10 years)
- Number of participants with a occurrence of hospitalization for infections (suspected/confirmed)(3, 5 and 10 years)
- Proteomics concentrations(Baseline, 3, 5 and 10 years)
- Metabolomics concentration(Baseline, 3, 5 and 10 years)
- Microbiome profile of stool(Baseline, 3, 5 and 10 years)
- Genome-, epigenom-, and RNA sequencing(Baseline, 3, 5 and 10 years)
研究者
Ellen Margrethe Hauge
Chair professor
University of Aarhus