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Completed

NCT Number: NCT02195388

Focus On Stiffness Reduction, Endothelial Function and Autonomic Nervous System

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.

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Key information

Conditions

Arterial Stiffness Acute Coronary Syndrome Arterial Hypertension Autonomic Nervous System Cardiovascular Diseases Endothelial Function Heart Diseases Hypertension Myocardial Ischemia Vascular Diseases

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Departament of Cardiology

Lodz, Łódź Voivodeship, 91-347, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

comprehensive cardiac rehabilitation

Other

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

Primary outcomes

  1. Arterial stiffness - Pulse wave velocity (PWV)

    Time frame: 24 month

    Arterial stiffness will be obtained by measuring carotid-femoral pulse wave velocity using Complior device.

  2. Arterial stiffness - Ambulatory arterial stiffness index (AASI)

    Time frame: 24 month

    AASI index will be calculated by non-commercial software using data from ambulatory blood pressure monitoring.

  3. Arterial stiffness - Augmentation index (AI)

    Time frame: 24 month

    AI will be calculated by EndoPAT2000 system.

Secondary outcomes

  1. Heart rate variability (HRV)

    Time frame: 24 month

    HRV parameters in time and frequency domain will be calculated by software Cardioscan 12.

  2. Heart rate turbulence (HRT)

    Time frame: 24 month

    HRT parameters will be calculated by Cardioscan 10 software.

Other outcomes

  1. Endothelial function - Reactive hyperaemia index(RHI)

    Time frame: 24 month

    RHI parameter of microvascular endothelial function will be calculated by EndoPAT2000 system.

  2. Endothelial function - VEGF-A, ADMA

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Medical University of Lodz

Other

Registry information

Official study 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.

Acronym: FOREVER

Important dates

Study start
2009
Primary completion
2014
Study completion
2015
First posted
Jul 21, 2014
Registry last updated
Mar 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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