FOREVER: Focus On Stiffness Reduction, Endothelial Function and Autonomic Nervous System

Sponsor

Medical University of Lodz (Other)

Overall Status

Completed

CT.gov ID

NCT02195388

Collaborator

(none)

120

Enrollment

Location

62.9

Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Arterial Stiffness Endothelial Function Autonomic Nervous System Acute Coronary Syndrome Arterial Hypertension	Other: comprehensive cardiac rehabilitation

Detailed Description

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.

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

120 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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.

Study Start Date :

Dec 1, 2009

Actual Primary Completion Date :

Dec 1, 2014

Actual Study Completion Date :

Mar 1, 2015

Arms and Interventions

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

Arm

Intervention/Treatment

CR with AH

Patients after ACS with arterial hypertension treat with comprehensive cardiac rehabilitation

Other: comprehensive cardiac rehabilitation

Standard program of comprehensive cardiac rehabilitation CR with physical activity, behavioral intervention, risk factor modification and intervention.

N-CR with AH

Patients after ACS with arterial hypertension don't treat with comprehensive cardiac rehabilitation.

CR without AH

Patients after ACS without arterial hypertension treat with comprehensive cardiac rehabilitation

Other: comprehensive cardiac rehabilitation

Standard program of comprehensive cardiac rehabilitation CR with physical activity, behavioral intervention, risk factor modification and intervention.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Heart rate variability (HRV) [24 month]
HRV parameters in time and frequency domain will be calculated by software Cardioscan 12.
Heart rate turbulence (HRT) [24 month]
HRT parameters will be calculated by Cardioscan 10 software.

Other Outcome Measures

Endothelial function - Reactive hyperaemia index(RHI) [24 month]
RHI parameter of microvascular endothelial function will be calculated by EndoPAT2000 system.
Endothelial function - VEGF-A, ADMA [24 month]
Group of 40 patient will be involved in sub-study with assessment of 2 markers of endothelial function: Vascular Endothelial Growth Factor A (VEGF-A) will be obtained by ELISA method to assess collateral circulation development during ischemia. Asymmetric dimethylarginine (ADMA) will be obtained by ELISA method to assess the ability of the synthesis of nitric oxide.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.