Focus On Stiffness Reduction, Endothelial Function and Autonomic Nervous System

Study Overview
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Brief Summary
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Myocardial infarction is related with endothelial function, arterial stiffness and autonomic nervous system dysfunction, but also with arterial hypertension. Hypertension by itself is also related with endothelial function, arterial stiffness and autonomic nervous system dysfunction. Primary aim of study is to investigate how complex cardiac rehabilitation influence endothelial function, arterial stiffness and autonomic nervous system activity according to presence or absence arterial hypertension. Secondary aim is to obtain correlation between methods for the assessment of particular disorders and intercorrelation between different disorders for example endothelial function and autonomic nervous system activity.

Detailed Description
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We expect that in study groups PWV will improve better that in control group. 5% of the limit value of p <0.05. We expect that in study groups AASI will improve better that in control group. 5% of the limit value of p <0.05. We expect that in study groups AI will improve better that in control group. 5% of the limit value of p <0.05. We expect that time and frequency parameters of HRV will increase in study group. 5% of the limit value of p <0.05. We expect that parameters of HRT will improve in study group. 5% of the limit value of p <0.05. We expect improvement in RHI in study group. 5% of the limit value of p <0.05.

Official Title
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Phase 1 Study - Focus On Stiffness Reduction, Endothelial Function and Autonomic Nervous System improVement in Patients After MI With or Without hypErtension After Cardiovascular Rehabilitation.

Conditions
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Arterial Stiffness, Endothelial Function, Autonomic Nervous System, Acute Coronary Syndrome, Arterial Hypertension

Intervention / Treatment
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* Other: comprehensive cardiac rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: after a recent troponin-positive acute coronary syndrome (within 7-30 days) treated by means of primary coronary angioplasty, age 20-85 year old, accepted and sign informed consent, Exclusion Criteria: unstable coronary artery disease, indications for a coronary artery bypass graft (CABG), peripheral artery disease, uncontrolled arterial hypertension, ventricular and supraventricular arrhythmias in excess of 10% of all the evolutions throughout the day, allergy to latex, deformities or condition after the amputation of fingers, body mass index (BMI) above 35 kg/m2, a significant hepatic or renal failure, infectious disease.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CR with AH<br>Patients after ACS with arterial hypertension treat with comprehensive cardiac rehabilitation | Other: comprehensive cardiac rehabilitation<br>* Standard program of comprehensive cardiac rehabilitation CR with physical activity, behavioral intervention, risk factor modification and intervention.<br>|
| N-CR with AH<br>Patients after ACS with arterial hypertension don't treat with comprehensive cardiac rehabilitation. | |
| CR without AH<br>Patients after ACS without arterial hypertension treat with comprehensive cardiac rehabilitation | Other: comprehensive cardiac rehabilitation<br>* Standard program of comprehensive cardiac rehabilitation CR with physical activity, behavioral intervention, risk factor modification and intervention.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arterial stiffness - Pulse wave velocity (PWV) | Arterial stiffness will be obtained by measuring carotid-femoral pulse wave velocity using Complior device. | 24 month | 
| Arterial stiffness - Ambulatory arterial stiffness index (AASI) | AASI index will be calculated by non-commercial software using data from ambulatory blood pressure monitoring. | 24 month | 
| Arterial stiffness - Augmentation index (AI) | AI will be calculated by EndoPAT2000 system. | 24 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate variability (HRV) | HRV parameters in time and frequency domain will be calculated by software Cardioscan 12. | 24 month | 
| Heart rate turbulence (HRT) | HRT parameters will be calculated by Cardioscan 10 software. | 24 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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arterial hypertension,, pulse wave velocity,, augmentation index,, arterial stiffness index,, heart rate variability,, heart rate turbulence,, vascular endothelial growth factor,, asymmetric dimethylarginine, Arterial stiffness,, endothelial function,, autonomic nervous system,, acute coronary syndrome,