Congestive Heart FailureNCT00745680
Speckle Tracking Imaging and Realtime 3 Dimensional Echocardiograhy to Study LV Function and Remodeling After Acute Myocardial Infarction (AMI)
An observational study of Congestive Heart Failure and Mitral Regurgitation, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Left ventricular (LV) remodeling after acute myocardial infarction (AMI) has been well described in previous studies. However, there is a paucity of data on the incidence of and risk factors for LV remodeling in modern clinical practice that incorporates widespread use of acute reperfusion strategies and almost… Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Congestive Heart Failure, Mitral Regurgitation
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- Oct 2007to Oct 2011
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients after AMI
Who may be able to join
- Structurally normal mitral and aortic valve;
- Technically adequate color flow Doppler image;
- Technically adequate real-time 3D echocardiographic image of the LV chamber and the mitral apparatus (annulus and leaflets) to allow analysis of 3D geometry;
- Normal sinus rhythm.
Who cannot join
- Recurrent MI or coronary reintervention during the follow up period;
- Clinical or echocardiographic evidence of other cardiac diseases, such as organic valvular, pericardial, congenital, or infiltrative heart disease;
- Right ventricular alterations resulting in abnormal position or movement of the septum.
Trial locations and contacts
1 site in 1 country.
Lung-Chun Lin, PhD. contact
Taiwan1 site, 1 recruiting
- Recruiting
NTUH
Taipei
Fun-Yu Lin, PhD, 23123456 ext. 5433
About this study
Official title: Morphodynamic Study of Left Ventricular Remodeling With Possible Mechanisms for Pharmacologic Therapy: Assessment by Real-time 3-dimensional Echocardiography and 2-dimensional Speck Tracking Imaging.
Left ventricular (LV) remodeling after acute myocardial infarction (AMI) has been well described in previous studies. However, there is a paucity of data on the incidence of and risk factors for LV remodeling in modern clinical practice that incorporates widespread use of acute reperfusion strategies and almost systematic use of "antiremodeling" medications, such as angiotensin-converting enzyme inhibitors and beta blockers. The recent improvements in AMI management do not abolish LV remodeling, which remains a relatively frequent event after an initial anterior wall AMI. As a leading cause of heart failure, postinfarction LV remodeling represents an important target for therapeutic interventions. Within the ventricular mass, size, shape, connections and orientation in a three-dimensional space of every single constituent determine its functional behavior. The complex architecture of the ventricular mass creates multiple inhomogeneities of electrical and mechanical loads at the cellular and the microscopic tissue level, that cause cardiac function to be 'stochastic in nature'. The myocardial infarction will altered the ventricular shape and functional inhomogeneities carrying the morphodynamic advantages such as impaired suction for diastole after diminishing recoil relaxation with decreased twisting strain in systole. The alteration in contractile mechanics interacts with the intraventricular fluid dynamic filed that influence the regional myocardial shearing stress. Altered LV transmural wall strains have been proposed to cause infarct extension and may have an important role in propagating LV remodeling.
Read the detailed description
We are currently witnessing the advent of new diagnostic tools and therapies for heart diseases, but,without serious scientific consensus on fundamental questions about normal and diseased heart structure and function. During the last decade, three successive, international, multidisciplinary symposia were organized in order to setup fundamental research principles, which would allow us to make a significant step forward in understanding heart structure and function. (Kocica MJ et al., 2006) Helical ventricular myocardial band (HVMB, Figure 2-1) of Torrent-Guasp is the revolutionary new concept in understanding global, three-dimensional, functional architecture of the ventricular myocardium. This concept defines the principal, cumulative vectors, integrating the tissue architecture (i.e. form) and net forces developed (i.e. function) within the ventricular mass. Helical ventricular myocardial band of Torrent-Guasp may also, hopefully, allow overcoming some difficulties encountered in contemporary efforts to create a comprehensive mathematical model of the heart.
Within the ventricular mass, size, shape, connections and orientation in a three-dimensional space of every single constituent determine its functional behavior. This kind of spatial dependence allows the ventricular myocardial mass to be considered as the source of interdependent vectorial forces (i.e.
electrical and mechanical), being generated on different length and time scales. The ultimate net result of these vectorial forces is to translate uniaxial sarcomere shortening into efficient three-dimensional deformation of the ventricular cavity. The complex architecture of the ventricular mass creates multiple inhomogeneities of electrical and mechanical loads at the cellular and the microscopic tissue level, that cause cardiac function to be 'stochastic in nature'. However, at macroscopic (i.e. organ) level, these stochastic events become average and appear consistent with a continuous medium. This dialectic coexistence of complexity and simplicity, discreetness and continuity suggests the existence of certain rule-based assignment, which 'may be applied equally well to all the ventricular myocardial fibers', enabling the ventricular myocardial mass to assemble abundant, dynamic, stochastic vectorial forces and produce apparently smooth, averaged, continuous, global response.
- Conditions
- Congestive Heart Failure, Mitral Regurgitation
- Keywords
- Left ventricular remodeling, acute myocardial infarction
- Medical subject headings
- Heart Failure, Mitral Valve Insufficiency, Ventricular Remodeling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| A | A: AMI patient |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2008 (estimated)
- Study startOct 2007
- Study completionOct 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive Heart FailureStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Lung-chun Lin, Ph D, Study director, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00745680
- Sponsor's protocol ID
- 200701057R
- Status last verified
- Jan 2011
- First submitted
- 31 Aug 2008
- Last updated
- 24 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Morphodynamic Study of Left Ventricular Remodeling With Possible Mechanisms for Pharmacologic Therapy: Assessment by Real-time 3-dimensional Echocardiography and 2-dimensional Speck Tracking Imaging.
- ClinicalTrials.gov ID
- NCT00745680
- Acronym / sponsor ID
- 200701057R
- Conditions
- Congestive Heart Failure, Mitral Regurgitation
- Keywords
- Left ventricular remodeling, acute myocardial infarction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Oct 2007
- Study completion
- Oct 2011 (estimated)
- First posted
- 3 Sep 2008 (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.
Left ventricular (LV) remodeling after acute myocardial infarction (AMI) has been well described in previous studies. However, there is a paucity of data on the incidence of and risk factors for LV remodeling in modern clinical practice that incorporates widespread use of acute reperfusion strategies and almost systematic use of "antiremodeling" medications, such as angiotensin-converting enzyme inhibitors and beta blockers. The recent improvements in AMI management do not abolish LV remodeling, which remains a relatively frequent event after an initial anterior wall AMI. As a leading cause of heart failure, postinfarction LV remodeling represents an important target for therapeutic interventions. Within the ventricular mass, size, shape, connections and orientation in a three-dimensional space of every single constituent determine its functional behavior. The complex architecture of the ventricular mass creates multiple inhomogeneities of electrical and mechanical loads at the cellular and the microscopic tissue level, that cause cardiac function to be 'stochastic in nature'. The myocardial infarction will altered the ventricular shape and functional inhomogeneities carrying the morphodynamic advantages such as impaired suction for diastole after diminishing recoil relaxation with decreased twisting strain in systole. The alteration in contractile mechanics interacts with the intraventricular fluid dynamic filed that influence the regional myocardial shearing stress. Altered LV transmural wall strains have been proposed to cause infarct extension and may have an important role in propagating LV remodeling.
Detailed description
We are currently witnessing the advent of new diagnostic tools and therapies for heart diseases, but,without serious scientific consensus on fundamental questions about normal and diseased heart structure and function. During the last decade, three successive, international, multidisciplinary symposia were organized in order to setup fundamental research principles, which would allow us to make a significant step forward in understanding heart structure and function. (Kocica MJ et al., 2006) Helical ventricular myocardial band (HVMB, Figure 2-1) of Torrent-Guasp is the revolutionary new concept in understanding global, three-dimensional, functional architecture of the ventricular myocardium. This concept defines the principal, cumulative vectors, integrating the tissue architecture (i.e. form) and net forces developed (i.e. function) within the ventricular mass. Helical ventricular myocardial band of Torrent-Guasp may also, hopefully, allow overcoming some difficulties encountered in contemporary efforts to create a comprehensive mathematical model of the heart.
Within the ventricular mass, size, shape, connections and orientation in a three-dimensional space of every single constituent determine its functional behavior. This kind of spatial dependence allows the ventricular myocardial mass to be considered as the source of interdependent vectorial forces (i.e.
electrical and mechanical), being generated on different length and time scales. The ultimate net result of these vectorial forces is to translate uniaxial sarcomere shortening into efficient three-dimensional deformation of the ventricular cavity. The complex architecture of the ventricular mass creates multiple inhomogeneities of electrical and mechanical loads at the cellular and the microscopic tissue level, that cause cardiac function to be 'stochastic in nature'. However, at macroscopic (i.e. organ) level, these stochastic events become average and appear consistent with a continuous medium. This dialectic coexistence of complexity and simplicity, discreetness and continuity suggests the existence of certain rule-based assignment, which 'may be applied equally well to all the ventricular myocardial fibers', enabling the ventricular myocardial mass to assemble abundant, dynamic, stochastic vectorial forces and produce apparently smooth, averaged, continuous, global response.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | – | –A: AMI patient |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients after AMI
Key inclusion criteria (4 listed)
- Structurally normal mitral and aortic valve;
- Technically adequate color flow Doppler image;
- Technically adequate real-time 3D echocardiographic image of the LV chamber and the mitral apparatus (annulus and leaflets) to allow analysis of 3D geometry;
- Normal sinus rhythm.
Key exclusion criteria (3 listed)
- Recurrent MI or coronary reintervention during the follow up period;
- Clinical or echocardiographic evidence of other cardiac diseases, such as organic valvular, pericardial, congenital, or infiltrative heart disease;
- Right ventricular alterations resulting in abnormal position or movement of the septum.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2011.
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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.
Lung-Chun Lin, PhD. contact
Lung-chun Lin, Ph D study director
National Taiwan University Hospital
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 Congestive Heart Failure and Mitral Regurgitation, run by National Taiwan University Hospital at 1 site in Taiwan.
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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 24 Jan 2011. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lung-Chun Lin, PhD. (anniejou@ms28.hinet.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 24 Jan 2011; AzTrials last refreshed its copy on 6 Nov 2026.