Effect of Exercise Training on the Autonomic Nervous System and Its Correlation With Platelet Aggregability in a Post-myocardial Infarction Population
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Platelet aggregability by VerifyNow-P2Y12®
Study Overview
Brief Summary
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).
Detailed Description
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Hospitalization for spontaneous STEMI or non-STEMI in patients older than 18 years.
Exclusion Criteria
- •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.
Arms & Interventions
Exercise Training
Patients randomized to the training group will start the supervised regular training program 01 month after the myocardial infarction, and it will last for three months.
Intervention: Exercise Training (Other)
Control Group
Patients in the control group will receive general instructions regarding rehabilitation post-acute myocardial infarction and will be followed for four months after the myocardial infarction.
Outcomes
Primary Outcomes
Platelet aggregability by VerifyNow-P2Y12®
Time Frame: 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.
Secondary Outcomes
- 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))
- Platelet aggregability by Multiplate-ADP®(After the first CPET (01 month post-AMI))
- Platelet aggregability by Multiplate-ASPI®(After the first CPET (01 month post-AMI))
Investigators
Talia Falcão Dalçóquio
Principal Investigator
University of Sao Paulo General Hospital