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: Completed
• Conditions: Acute Coronary Syndrome; Arterial Hypertension; Endothelial Function; Arterial Stiffness; Autonomic Nervous System
• Intervention / Treatment: Other: comprehensive cardiac rehabilitation

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: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• Poland
  • Lodzkie
    • Lodz, Lodzkie, Poland, 91-347
      • Departament of Cardiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patient after troponin-positive acute coronary syndrome (ACS) with or without arterial hypertension.

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?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CR with AH; Patients after ACS with arterial hypertension treat with comprehensive cardiac rehabilitation	Other: 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	Other: 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)	Arterial stiffness will be obtained by measuring carotid-femoral pulse wave velocity using Complior device.	24 month
Arterial stiffness - Ambulatory arterial stiffness index (AASI)	AASI index will be calculated by non-commercial software using data from ambulatory blood pressure monitoring.	24 month
Arterial stiffness - Augmentation index (AI)	AI will be calculated by EndoPAT2000 system.	24 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate variability (HRV)	HRV parameters in time and frequency domain will be calculated by software Cardioscan 12.	24 month
Heart rate turbulence (HRT)	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)	RHI parameter of microvascular endothelial function will be calculated by EndoPAT2000 system.	24 month
Endothelial function - VEGF-A, ADMA	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: Medical University of Lodz
• Investigators: Study Chair: Malgorzata Kurpesa, Professor, Departament of Cardiology Medical University of Lodz

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: July 16, 2014
• First Submitted That Met QC Criteria: July 17, 2014
• First Posted (Estimate): July 21, 2014

Study Record Updates

• Last Update Posted (Actual): March 23, 2017
• Last Update Submitted That Met QC Criteria: March 21, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: asymmetric dimethylarginine; vascular endothelial growth factor,; endothelial function,; Arterial stiffness,; autonomic nervous system,; acute coronary syndrome,; arterial hypertension,; pulse wave velocity,; augmentation index,; arterial stiffness index,; heart rate variability,; heart rate turbulence,
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Hypertension; Acute Coronary Syndrome
• Other Study ID Numbers: FOREVER-1