Effect of Long-term Exercise on Haemostasis and Inflammation Compared With Standard Care in Patients With Stable Coronary Artery Disease: a Randomised Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 142
- 试验地点
- 2
- 主要终点
- Changes in clot maximum absorbance using the clot lysis assay.
研究概览
简要总结
Introduction: Regular exercise training improves prognosis in patients with coronary artery disease (CAD). This study investigates whether the beneficial effects of exercise can be partly explained by favourable changes in haemostasis and inflammation.
Methods: 150 CAD patients are randomised to a supervised long-term exercise program (3 months) or usual care. Blood samples are obtained at baseline, 1.5 months, and 3 months after randomisation.
Results: The investigators will evaluate platelet turnover and aggregation, coagulation, fibrinolysis, and inflammatory markers before and after short- and long-term exercise, and the two randomised groups will be compared.
Perspectives: The present study will increase our knowledge of the beneficial mechanisms underlying the effect of exercise in CAD patients, potentially paving the way for improved exercise recommendations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Age ≥ 18 years
- •Angiographically verified coronary artery disease with stenosis of at least 50% or previous percutaneous coronary intervention (PCI)/coronary artery bypass graft (CABG) surgery.
- •Diagnosis or revascularisation have been made at least 12 months prior to inclusion.
排除标准
- •Inability to perform strenuous exercise
- •Anticoagulant treatment
- •Heart failure (ejection fraction <30% or NYHA >2)
- •Implanted implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT)
- •Serious arrhythmia requiring hospitalisation within the last 6 months
- •Severe valvular heart disease
- •Chronic obstructive pulmonary disease GOLD IV
结局指标
主要结局
Changes in clot maximum absorbance using the clot lysis assay.
时间窗: 3 months
Changes in maximum absorbance in coronary artery disease patients who are randomised to long-term exercise compared with patients randomised to usual care (control group). Moreover, the investigators will compare clot maximum absorbance assessed at baseline and after three months of supervised exercise for every patient.
Changes in fibrinolytic biomarkers: tissue plasminogen activator (t-PA) and plasminogen activator inhibitor-1 (PAI-1).
时间窗: 3 months
Changes in fibrinolytic biomarkers in coronary artery disease patients who are randomised to long-term exercise compared with patients randomised to usual care (control group). Moreover, the investigators will compare fibrinolytic biomarkers assessed at baseline and after three months of supervised exercise for every patient.
Changes in clot lysis time using the clot lysis assay.
时间窗: 3 months
Changes in clot lysis time in coronary artery disease patients who are randomised to long-term exercise compared with patients randomised to usual care (control group). Moreover, the investigators will compare clot lysis time assessed at baseline and after three months of supervised exercise for every patient.
Changes in area under the curve using the clot lysis assay.
时间窗: 3 months
Changes in area under the curve in coronary artery disease patients who are randomised to long-term exercise compared with patients randomised to usual care (control group). Moreover, the investigators will compare area under the curve assessed at baseline and after three months of supervised exercise for every patient.
次要结局
- Changes in platelet aggregation using arachidonic acid (ASPI) as agonist.(3 months)
- Changes in thrombin generation assessing maximum concentration of thrombin.(3 months)
- Changes in thrombin generation assessing time to peak.(3 months)
- Changes in platelet aggregation using adenosine diphosphate (ADP) as agonist.(3 months)
- Changes in platelet aggregation using thrombin receptor activating peptide-6 (TRAP) as agonist.(3 months)
- Changes in inflammatory biomarkers: CRP, multiple interleukins, tumor necrosis factor alpha (TNF-α), interferon gamma (INF-γ) and more.(3 months)
- Changes in thrombin generation assessing lag-time until initial thrombin generation.(3 months)
- Changes in thrombin generation assessing endogenous thrombin potential.(3 months)
- Changes in coagulation biomarkers: APTT, INR, Factor VIII, vWF.(3 months)
研究者
Jacobina Kristiansen
M.D., PhD-student
Aarhus University Hospital