Focus On Stiffness Reduction, Endothelial Function and Autonomic Nervous System

Completed

• Conditions: Endothelial Function; Acute Coronary Syndrome; Arterial Hypertension; Autonomic Nervous System; Arterial Stiffness
• Interventions: Other: comprehensive cardiac rehabilitation

• Registration Number: NCT02195388
• Lead Sponsor: Medical University of Lodz

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.

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2014-07-16
• Study First Submitted QC: 2014-07-17
• Study First Posted: 2014-07-21
• Primary Completion: 2014-12
• Study Completion: 2015-03
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-21
• Last Update Posted: 2017-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CR without AH	comprehensive cardiac rehabilitation	Patients after ACS without arterial hypertension treat with comprehensive cardiac rehabilitation
CR with AH	comprehensive cardiac rehabilitation	Patients after ACS with arterial hypertension treat with comprehensive cardiac rehabilitation

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Departament of Cardiology; 🇵🇱 Lodz, Lodzkie, Poland