Clinical trial NCT02195388: Focus On Stiffness Reduction, Endothelial Function and Autonomic Nervous System
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arterial Stiffness
Endothelial Function
Autonomic Nervous System
Acute Coronary Syndrome
Arterial Hypertension
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
Lead sponsor: Medical University of Lodz
Sponsor class: OTHER
First posted: 2014-07-21
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient after troponin-positive acute coronary syndrome (ACS) with or without arterial hypertension.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Arterial stiffness - Pulse wave velocity (PWV)
timeFrame: 24 month
measure: Arterial stiffness - Ambulatory arterial stiffness index (AASI)
timeFrame: 24 month
measure: Arterial stiffness - Augmentation index (AI)
timeFrame: 24 month
Secondary outcomes:
measure: Heart rate variability (HRV)
timeFrame: 24 month
measure: Heart rate turbulence (HRT)
timeFrame: 24 month
Other outcomes:
measure: Endothelial function - Reactive hyperaemia index(RHI)
timeFrame: 24 month
measure: Endothelial function - VEGF-A, ADMA
timeFrame: 24 month
Locations:
city: Lodz
country: Poland
facility: Departament of Cardiology
state: Lodzkie
Study officials:
affiliation: Departament of Cardiology Medical University of Lodz
name: Malgorzata Kurpesa, Professor
role: STUDY_CHAIR
References: