Focus On Stiffness Reduction, Endothelial Function and Autonomic Nervous System

NCT ID: NCT02195388

Last Updated: 2017-03-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-12-31

Study Completion Date

2015-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

CR with AH

Patients after ACS with arterial hypertension treat with comprehensive cardiac rehabilitation

comprehensive cardiac rehabilitation

Intervention Type OTHER

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.

No interventions assigned to this group

CR without AH

Patients after ACS without arterial hypertension treat with comprehensive cardiac rehabilitation

comprehensive cardiac rehabilitation

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

comprehensive cardiac rehabilitation

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Medical University of Lodz

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Urszula Cieslik-Guerra

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Malgorzata Kurpesa, Professor

Role: STUDY_CHAIR

Departament of Cardiology Medical University of Lodz

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Departament of Cardiology

Lodz, Łódź Voivodeship, Poland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Poland

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

FOREVER-1

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.