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Focus On Stiffness Reduction, Endothelial Function and Autonomic Nervous System

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.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02195388
Acronym
FOREVER
Enrollment
120
Registered
2014-07-21
Start date
2009-12-31
Completion date
2015-03-31
Last updated
2017-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Arterial stiffness,, endothelial function,, autonomic nervous system,, acute coronary syndrome,, arterial hypertension,, pulse wave velocity,, augmentation index,, arterial stiffness index,, heart rate variability,, heart rate turbulence,, vascular endothelial growth factor,, asymmetric dimethylarginine

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.

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.

Interventions

OTHERcomprehensive cardiac rehabilitation

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

Sponsors

Medical University of Lodz
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
No

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.

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
Heart rate turbulence (HRT)24 monthHRT parameters will be calculated by Cardioscan 10 software.
Heart rate variability (HRV)24 monthHRV parameters in time and frequency domain will be calculated by software Cardioscan 12.

Other

MeasureTime frameDescription
Endothelial function - VEGF-A, ADMA24 monthGroup 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.
Endothelial function - Reactive hyperaemia index(RHI)24 monthRHI parameter of microvascular endothelial function will be calculated by EndoPAT2000 system.

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026