Focus On Stiffness Reduction, Endothelial Function and Autonomic Nervous System

Acute Coronary Syndrome Clinical Trial

— FOREVER  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02195388
• Other study ID #: FOREVER-1
• Status: Completed
• Phase: N/A
• First received: July 16, 2014
• Last updated: March 21, 2017
• Start date: December 2009
• Est. completion date: March 2015

Study information

• Verified date: March 2017
• Source: Medical Universtity of Lodz
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: March 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Arterial Hypertension
• Arterial Stiffness
• Autonomic Nervous System
• Endothelial Function
• Hypertension

Intervention

Other:
• comprehensive cardiac rehabilitation
Standard program of comprehensive cardiac rehabilitation CR with physical activity, behavioral intervention, risk factor modification and intervention.

Locations

Country	Name	City	State
Poland	Departament of Cardiology	Lodz	Lodzkie

Sponsors (1)

Lead Sponsor	Collaborator
Medical Universtity of Lodz

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Endothelial function - Reactive hyperaemia index(RHI)	RHI parameter of microvascular endothelial function will be calculated by EndoPAT2000 system.	24 month
Other	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
Primary	Arterial stiffness - Pulse wave velocity (PWV)	Arterial stiffness will be obtained by measuring carotid-femoral pulse wave velocity using Complior device.	24 month
Primary	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
Primary	Arterial stiffness - Augmentation index (AI)	AI will be calculated by EndoPAT2000 system.	24 month
Secondary	Heart rate variability (HRV)	HRV parameters in time and frequency domain will be calculated by software Cardioscan 12.	24 month
Secondary	Heart rate turbulence (HRT)	HRT parameters will be calculated by Cardioscan 10 software.	24 month