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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Medical Universtity of Lodz
Sponsor:
Information provided by (Responsible Party):
Urszula Cieslik-Guerra, Medical Universtity of Lodz
ClinicalTrials.gov Identifier:
NCT02195388
First received: July 16, 2014
Last updated: July 24, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Arterial Stiffness,
Endothelial Function,
Autonomic Nervous System,
Acute Coronary Syndrome,
Arterial Hypertension
Other: comprehensive cardiac rehabilitation

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Medical Universtity of Lodz:

Primary Outcome Measures:
  • Arterial stiffness - Pulse wave velocity (PWV) [ Time Frame: 24 month ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    AI will be calculated by EndoPAT2000 system.


Secondary Outcome Measures:
  • Heart rate variability (HRV) [ Time Frame: 24 month ] [ Designated as safety issue: Yes ]
    HRV parameters in time and frequency domain will be calculated by software Cardioscan 12.

  • Heart rate turbulence (HRT) [ Time Frame: 24 month ] [ Designated as safety issue: Yes ]
    HRT parameters will be calculated by Cardioscan 10 software.


Other Outcome Measures:
  • Endothelial function - Reactive hyperaemia index(RHI) [ Time Frame: 24 month ] [ Designated as safety issue: Yes ]
    RHI parameter of microvascular endothelial function will be calculated by EndoPAT2000 system.

  • Endothelial function - VEGF-A, ADMA [ Time Frame: 24 month ] [ Designated as safety issue: Yes ]

    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.



Biospecimen Retention:   Samples Without DNA

VEGF-A, ADMA, NT-proBNP, creatinine, uric acid, LDL, HDL, total cholesterol, trigliceride, ALT,GGTP, CRP, fibrinogen,


Estimated Enrollment: 120
Study Start Date: December 2009
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   20 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02195388

Contacts
Contact: Urszula I Cieslik-Guerra, M.D. 501061075 ext +48 cieursz@wp.pl
Contact: Malgorzata Kurpesa, Professor 422516074 ext +48

Locations
Poland
Departament of Cardiology Recruiting
Lodz, Lodzkie, Poland, 91-347
Contact: Urszula I Cieslik-Guerra, M.D.    501061075 ext +48    cieursz@wp.pl   
Contact: Malgorzata Kurpesa, Professor    422516074 ext +48      
Principal Investigator: Urszula I Cieslik-Guerra, M.D.         
Sponsors and Collaborators
Medical Universtity of Lodz
Investigators
Study Chair: Malgorzata Kurpesa, Professor Departament of Cardiology Medical University of Lodz
  More Information

No publications provided

Responsible Party: Urszula Cieslik-Guerra, M.D., Medical Universtity of Lodz
ClinicalTrials.gov Identifier: NCT02195388     History of Changes
Other Study ID Numbers: FOREVER-1
Study First Received: July 16, 2014
Last Updated: July 24, 2014
Health Authority: Poland: Ministry of Science and Higher Education

Keywords provided by Medical Universtity of Lodz:
Arterial stiffness,
endothelial function,
autonomic nervous system,
acute coronary syndrome,
arterial hypertension,
pulse wave velocity,
augmentation index,
arterial stiffness index,
heart rate variability,
heart rate turbulence,
vascular endothelial growth factor,
asymmetric dimethylarginine

Additional relevant MeSH terms:
Hypertension
Syndrome
Acute Coronary Syndrome
Vascular Diseases
Cardiovascular Diseases
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Angina Pectoris
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014