Effect of Exercise Training on the Autonomic Nervous System and Its Correlation With Platelet Aggregability in a Post-myocardial Infarction Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Platelet aggregability by VerifyNow-P2Y12®
研究概览
简要总结
This project aims to evaluate, in recent post-acute myocardial infarction (AMI) patients on dual antiplatelet therapy, the impact of regular exercise training on platelet aggregability and the correlation between the level of platelet aggregability and muscle sympathetic nerve activity (MSNA).
详细描述
- Introduction:
Platelet reactivity is closely involved in the pathophysiology of acute coronary syndromes (ACS). However, despite the development of newer and more effective antiplatelet drugs (among other therapeutic interventions), the risk of ischemic events recurrence after an episode of ACS is still high.
On the other hand, acute and strenuous exercise, a known trigger of ACS, when performed by untrained individuals, leads to sympathetic hyperactivity and increased platelet aggregability. Contrary to these findings, regular supervised exercise training leads to regulation of the autonomic system with consequent decrease in the incidence of ACS, as shown in previous studies. However, the relationship between regular supervised exercise training on platelet activity in patients post-AMI on dual antiplatelet therapy, has not been previously studied and is the main goal of the present project. 2. Objectives:
This project aims to evaluate, in recent post-AMI patients on dual antiplatelet therapy, the impact of regular exercise training on platelet aggregability, analyzed by VerifyNowP2Y12® test. Secondary exploratory analysis includes: 1) the influence of acute and strenuous exercise on platelet aggregability measured immediately after the two cardiopulmonary exercise testing (CPET) that patients will be submitted; 2) the correlation between the level of platelet aggregability and MSNA in trained and control groups; 3) the influence of exercise training on platelet aggregability measured by Multiplate® adenosine diphosphate (ADP) test and Multiplate® aspirin (ASPI) test; 4) the influence of exercise training on the mean platelet volume (MPV) and platelet count; 5) the influence of exercise training in other laboratorial parameters as lipids, blood glucose and inflammatory activity; 6) finally, the primary endpoint of the study will be evaluated in different prespecified subgroups such as diabetics, elderly, obese and patients with chronic kidney disease.
2.1. Primary endpoint of the study: Evaluate the influence of regular supervised exercise training for 3 months on platelet aggregability, analyzed by VerifyNowP2Y12® test, in patients with recent AMI utilizing dual antiplatelet therapy.
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
- None
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
- •Hospitalization for spontaneous STEMI or non-STEMI in patients older than 18 years.
排除标准
- •Any condition that contraindicate physical activity;
- •Regular exercise training practitioners prior to the ischemic event;
- •Planned revascularization in the following 4 months;
- •Hospitalization for cardiovascular events in the previous 12 months;
- •Ventricular dysfunction, defined as left ventricular ejection fraction (LVEF) <45% on echocardiography, evaluated by Simpson's method);f) Killip class III and IV;
- •High risk of arrhythmia and/or second and third degree atrioventricular block;
- •Diabetes mellitus requiring intravenous insulin therapy during hospitalization;
- •Important chronic kidney disease, defined by creatinine clearance<30ml/min/m2 (estimated by MDRD formula);
- •Oral anticoagulation;
- •Use of NSAIDs and/or dipyridamole;
- •Contraindication to dual antiplatelet therapy;
- •Serum hemoglobin level <10 g/dL;
- •Use of glycoprotein IIB/IIIA inhibitors in the last 48 hours;
- •Terminal illness;
- •Liver disease or coagulopathy;
- •Refusal to engage in an exercise training program.
结局指标
主要结局
Platelet aggregability by VerifyNow-P2Y12®
时间窗: Before the second CPET (04 months pot-AMI)
To measure in recent post-AMI patients on dual antiplatelet therapy the impact of 03 months of regular exercise training (starting 30 days after the AMI) on platelet aggregability, analyzed by VerifyNow-P2Y12® test.
次要结局
- Platelet aggregability by Multiplate-ASPI®(After the second CPET (04 months post-AMI))
- Sympathetic activity by MSNA(Before the second CPET (04 months post-AMI))
- Platelet aggregability by Multiplate-ADP®(After the second CPET (04 months post-AMI))
研究者
Talia Falcão Dalçóquio
Principal Investigator
University of Sao Paulo General Hospital