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.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Medical University of Lodz
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Arterial stiffness - Pulse wave velocity (PWV)
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 20 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Outcomes
Primary Outcomes
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.
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.
Arterial stiffness - Augmentation index (AI)
Time Frame: 24 month
AI will be calculated by EndoPAT2000 system.
Secondary Outcomes
- Heart rate variability (HRV)(24 month)
- Heart rate turbulence (HRT)(24 month)
Investigators
Urszula Cieslik-Guerra
M.D.
Medical University of Lodz