- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02195388
Focus On Stiffness Reduction, Endothelial Function and Autonomic Nervous System (FOREVER)
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.
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Lodzkie
-
Lodz, Lodzkie, Poland, 91-347
- Departament of Cardiology
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
CR with AH
Patients after ACS with arterial hypertension treat with comprehensive cardiac rehabilitation
|
Standard program of comprehensive cardiac rehabilitation CR with physical activity, behavioral intervention, risk factor modification and intervention.
|
N-CR with AH
Patients after ACS with arterial hypertension don't treat with comprehensive cardiac rehabilitation.
|
|
CR without AH
Patients after ACS without arterial hypertension treat with comprehensive cardiac rehabilitation
|
Standard program of comprehensive cardiac rehabilitation CR with physical activity, behavioral intervention, risk factor modification and intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
24 month
|
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.
|
24 month
|
Arterial stiffness - Augmentation index (AI)
Time Frame: 24 month
|
AI will be calculated by EndoPAT2000 system.
|
24 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Heart rate variability (HRV)
Time Frame: 24 month
|
HRV parameters in time and frequency domain will be calculated by software Cardioscan 12.
|
24 month
|
Heart rate turbulence (HRT)
Time Frame: 24 month
|
HRT parameters will be calculated by Cardioscan 10 software.
|
24 month
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Endothelial function - Reactive hyperaemia index(RHI)
Time Frame: 24 month
|
RHI parameter of microvascular endothelial function will be calculated by EndoPAT2000 system.
|
24 month
|
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. |
24 month
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Malgorzata Kurpesa, Professor, Departament of Cardiology Medical University of Lodz
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FOREVER-1
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