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

Medical University of Lodz

Status: Completed

Conditions: Endothelial Function; Acute Coronary Syndrome; Arterial Hypertension; Autonomic Nervous System; Arterial Stiffness

Treatments: Other: comprehensive cardiac rehabilitation

Study type: Observational

Funder types: Other

Identifiers

NCT02195388

FOREVER-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 20 to 85 years old

Volunteers: No 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.

Trial design

120 participants in 3 patient groups

CR with AH

Description:

Patients after ACS with arterial hypertension treat with comprehensive cardiac rehabilitation

Treatment:

Other: comprehensive cardiac rehabilitation

N-CR with AH

Description:

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

CR without AH

Description:

Patients after ACS without arterial hypertension treat with comprehensive cardiac rehabilitation

Treatment:

Other: comprehensive cardiac rehabilitation