Arterial StiffnessFOREVERNCT02195388
Focus On Stiffness Reduction, Endothelial Function and Autonomic Nervous System
An observational study of Arterial Stiffness and Endothelial Function, run by Medical University of Lodz at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Arterial Stiffness, Endothelial Function, Autonomic Nervous System
- What is being tested?
- comprehensive cardiac rehabilitation
- How many people
- 120 participants
- Where
- 1 sitePoland
- Study dates
- Dec 2009to Mar 2015
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient after troponin-positive acute coronary syndrome (ACS) with or without arterial hypertension.
Who may be able to join
- 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,
Who cannot join
- 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,
Show all 10Show fewer
- deformities or condition after the amputation of fingers,
- body mass index (BMI) above 35 kg/m2,
- a significant hepatic or renal failure,
- infectious disease.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Arterial Stiffness, Endothelial Function, Autonomic Nervous System, Acute Coronary Syndrome, Arterial Hypertension
- Being tested
- comprehensive cardiac rehabilitation
- Keywords
- 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
- Medical subject headings
- Acute Coronary Syndrome, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
comprehensive cardiac rehabilitationOther
Standard program of comprehensive cardiac rehabilitation CR with physical activity, behavioral intervention, risk factor modification and intervention.
| Study group | Role | What they receive |
|---|---|---|
| CR with AH | Patients after ACS with arterial hypertension treat with comprehensive cardiac rehabilitation Receives: Other: comprehensive cardiac rehabilitation | |
| 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 Receives: Other: comprehensive cardiac rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial stiffness - Pulse wave velocity (PWV)
Arterial stiffness will be obtained by measuring carotid-femoral pulse wave velocity using Complior device.
Measured: 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.
Measured: 24 month
Arterial stiffness - Augmentation index (AI)
AI will be calculated by EndoPAT2000 system.
Measured: 24 month
Secondary outcomes (2)
Heart rate variability (HRV)
HRV parameters in time and frequency domain will be calculated by software Cardioscan 12.
Measured: 24 month
Heart rate turbulence (HRT)
HRT parameters will be calculated by Cardioscan 10 software.
Measured: 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2014 (estimated)
- Study startDec 2009
- Primary completionDec 2014
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arterial StiffnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Medical University of Lodz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Urszula Cieslik-Guerra, Medical University of Lodz
- Investigators
- Malgorzata Kurpesa, Professor, Study chair, Departament of Cardiology Medical University of Lodz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02195388
- Sponsor's protocol ID
- FOREVER-1
- Acronym
- FOREVER
- Status last verified
- Mar 2017
- First submitted
- 16 Jul 2014
- Last updated
- 23 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02195388
- Acronym / sponsor ID
- FOREVER / FOREVER-1
- Conditions
- Arterial Stiffness, Endothelial Function, Autonomic Nervous System, Acute Coronary Syndrome, Arterial Hypertension
- Keywords
- Arterial stiffness,, endothelial function,, autonomic nervous system,, acute coronary syndrome,, arterial hypertension,, pulse wave velocity,, augmentation index,, arterial stiffness index,
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Medical University of LodzUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Dec 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 21 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CR with AH | – | Other: comprehensive cardiac rehabilitationPatients after ACS with arterial hypertension treat with comprehensive cardiac rehabilitation |
| N-CR with AH | – | –Patients after ACS with arterial hypertension don't treat with comprehensive cardiac rehabilitation. |
| CR without AH | – | Other: comprehensive cardiac rehabilitationPatients after ACS without arterial hypertension treat with comprehensive cardiac rehabilitation |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient after troponin-positive acute coronary syndrome (ACS) with or without arterial hypertension.
Key inclusion criteria (3 listed)
- 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,
Key exclusion criteria (10 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| comprehensive cardiac rehabilitationStandard program of comprehensive cardiac rehabilitation CR with physical activity, behavioral intervention, risk factor modification and intervention. | Other | CR with AH, CR without AH |
Primary outcome
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.
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.
Arterial stiffness - Augmentation index (AI)
Time frame: 24 month
AI will be calculated by EndoPAT2000 system.
2 secondary outcomes
Heart rate variability (HRV)
Time frame: 24 month
Heart rate turbulence (HRT)
Time frame: 24 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Malgorzata Kurpesa, Professor study chair
Departament of Cardiology Medical University of Lodz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arterial Stiffness and Endothelial Function, run by Medical University of Lodz at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arterial stiffness - Pulse wave velocity (PWV) (time frame: 24 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2017.