Myocardial Viability in Ischemic Left Ventricular DysfunctionNCT00476320
The Use of Myocardial Deformation Imaging
An observational study of Myocardial Viability in Ischemic Left Ventricular Dysfunction and Prediction for Improvement in Cardiac Function After Revascularization Therapy, run by RWTH Aachen University at 1 site in Germany.
Trial summary
Myocardial deformation imaging allows analysis of myocardial viability in ischemic left ventricular dysfunction. This study will evaluate the predictive value of myocardial deformation imaging for improvement in cardiac function after revascularization therapy in comparison to contrast-enhanced cardiac magnetic… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Myocardial Viability in Ischemic Left Ventricular Dysfunction, Prediction for Improvement in Cardiac Function After Revascularization Therapy
- What is being tested?
- Magnetic Resonance Imaging, Revascularization and Echocardiography with myocardial deformation imaging
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteGermany
- Study dates
- Aug 2004to Apr 2007
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with ischemic left ventricular dysfunction scheduled for coronary revascularization
Who cannot join
- Patients with acute coronary syndrome and poor echocardiographic windows
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of Myocardial Deformation Imaging Based on Ultrasonic Pixel Tracking to Identify Reversible Myocardial Dysfunction
Myocardial deformation imaging allows analysis of myocardial viability in ischemic left ventricular dysfunction. This study will evaluate the predictive value of myocardial deformation imaging for improvement in cardiac function after revascularization therapy in comparison to contrast-enhanced cardiac magnetic resonance imaging (ceMRI).
In 55 patients with ischemic left ventricular dysfunction, myocardial viability was assessed using pixel-tracking-derived myocardial deformation imaging and ceMRI to predict recovery of function at 9±2 months follow-up. For each left ventricular segment in a 16-segment model peak systolic radial strain will be determined from parasternal 2D echocardiographic views and the amount of late hyperenhancement (LE) and maximal thickness of myocardial tissue without LE using ceMRI. The hypothesis is that compared with segments showing functional improvement, those that failed to recover had lower radial strain and lower thickness without LE and higher LE.
Read the detailed description
Between August 2004 and June 2006 195 patients with ischemic left ventricular dysfunction underwent MRI for the definition of myocardial viability. Onehundred-ten patients with non-ischemic cardiomyopathy or acute coronary syndromes were excluded from the study to avoid possible acute ischemia or stunning. Within the 85 patients with chronic ischemic heart disease, six patients refused participation in this study and five patients had echocardiographic windows insufficient for participation. Within the remaining 74 patients 55 patients underwent revascularization and 19 had no revascularization. These 55 patients form our study group! Functional recovery will be assessed using echocardiographic images before and 9±2 months after revascularization with a Vivid Seven System (GE Vingmed, Horton, Norway). Parasternal long-axis and short-axis views at basal, midventricular and apical levels, as well as 3 standard apical views (4 chamber, 2 chamber, and long axis) have been acquired (frame rate 56 to 92 frames/s). Segmental wall motion will be determined using the following score: 1=normokinetic, 1.5= mildly hypokinetic, 2= moderately or severely hypokinetic, 3= akinetic, or 4= dyskinetic. A segment is considered to demonstrate functional improvement during follow-up if it improved by at least 1 grade. Global functional recovery was considered in case of an increase in ejection fraction>5% at follow-up.
The three acquired parasternal short axis views will be analysed with the aid of a dedicated software package (EchoPAC BT 05.2, GE Vingmed, Horton, Norway). This system allows analysis of peak systolic circumferential and radial strain from short axis views based on detection of natural acoustic markers. The system calculates mean strain values for whole predefined LV segments, including all myocardial layers from the endocardium to epicardium.
All patients underwent cMRI within a few hours of the baseline echocardiographic study on a 1.5-T whole-body MR scanner (Intera, Best, Philips, the Netherlands). The assignment to a hyperenhancement category reflects the extent of hyperenhancement within each segment by visual assessment considering a 5-group scale: 0% hyperenhancement (group 1), 1 to 25% hyperenhancement (group 2), 26 to 50% hyperenhancement (group 3), 51 to 75% hyperenhancement (group 4) and 76 to 100% hyperenhancement (group 5).
In addition, the maximal thickness of myocardial tissue without late hyperenhancement will be determined for each LV segment. This is considered to be a parameter of the remaining viable myocardium.
- Conditions
- Myocardial Viability in Ischemic Left Ventricular Dysfunction, Prediction for Improvement in Cardiac Function After Revascularization Therapy
- Being tested
- Magnetic Resonance Imaging, Revascularization, Echocardiography with myocardial deformation imaging
- Keywords
- echocardiography, myocardial infarction, magnetic resonance imaging, revascularization, viability
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance ImagingProcedure or surgery
RevascularizationProcedure or surgery
Echocardiography with myocardial deformation imagingProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2007 (estimated)
- Study startAug 2004
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Myocardial Viability in Ischemic Left Ventricular DysfunctionStudies 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
- Defined population
- Time perspective
- Other
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Investigators
- Michael Becker, PhD, MD, Principal investigator, RWTH Aachen University HospitalRainer Hoffmann, Professor, Study chair, RWTH Aachen University HospitalMalte Kelm, Professor, Study director, RWTH Aachen University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00476320
- Sponsor's protocol ID
- Becker-LE-FU-2007
- Status last verified
- May 2007
- First submitted
- 21 May 2007
- Last updated
- 22 May 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Becker M, Hoffmann R, Kuhl HP, Grawe H, Katoh M, Kramann R, Bucker A, Hanrath P, Heussen N. Analysis of myocardial deformation based on ultrasonic pixel tracking to determine transmurality in chronic myocardial infarction. Eur Heart J. 2006 Nov;27(21):2560-6. doi: 10.1093/eurheartj/ehl288. Epub 2006 Oct 11.
PubMed 17035253Kim RJ, Wu E, Rafael A, Chen EL, Parker MA, Simonetti O, Klocke FJ, Bonow RO, Judd RM. The use of contrast-enhanced magnetic resonance imaging to identify reversible myocardial dysfunction. N Engl J Med. 2000 Nov 16;343(20):1445-53. doi: 10.1056/NEJM200011163432003.
PubMed 11078769Reisner SA, Lysyansky P, Agmon Y, Mutlak D, Lessick J, Friedman Z. Global longitudinal strain: a novel index of left ventricular systolic function. J Am Soc Echocardiogr. 2004 Jun;17(6):630-3. doi: 10.1016/j.echo.2004.02.011.
PubMed 15163933Becker M, Altiok E, Lente C, Otten S, Friedman Z, Adam D, Hoffmann R, Koos R, Krombach G, Marx N, Hoffmann R. Layer-specific analysis of myocardial function for accurate prediction of reversible ischaemic dysfunction in intermediate viability defined by contrast-enhanced MRI. Heart. 2011 May;97(9):748-56. doi: 10.1136/hrt.2010.210906. Epub 2011 Mar 17.
PubMed 21415076Becker M, Lenzen A, Ocklenburg C, Stempel K, Kuhl H, Neizel M, Katoh M, Kramann R, Wildberger J, Kelm M, Hoffmann R. Myocardial deformation imaging based on ultrasonic pixel tracking to identify reversible myocardial dysfunction. J Am Coll Cardiol. 2008 Apr 15;51(15):1473-81. doi: 10.1016/j.jacc.2007.10.066.
PubMed 18402903
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Myocardial Deformation Imaging Based on Ultrasonic Pixel Tracking to Identify Reversible Myocardial Dysfunction
- ClinicalTrials.gov ID
- NCT00476320
- Acronym / sponsor ID
- Becker-LE-FU-2007
- Conditions
- Myocardial Viability in Ischemic Left Ventricular Dysfunction, Prediction for Improvement in Cardiac Function After Revascularization Therapy
- Keywords
- echocardiography, myocardial infarction, magnetic resonance imaging, revascularization, viability
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- Aug 2004
- Study completion
- Apr 2007 (actual)
- First posted
- 22 May 2007 (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 deformation imaging allows analysis of myocardial viability in ischemic left ventricular dysfunction. This study will evaluate the predictive value of myocardial deformation imaging for improvement in cardiac function after revascularization therapy in comparison to contrast-enhanced cardiac magnetic resonance imaging (ceMRI).
In 55 patients with ischemic left ventricular dysfunction, myocardial viability was assessed using pixel-tracking-derived myocardial deformation imaging and ceMRI to predict recovery of function at 9±2 months follow-up. For each left ventricular segment in a 16-segment model peak systolic radial strain will be determined from parasternal 2D echocardiographic views and the amount of late hyperenhancement (LE) and maximal thickness of myocardial tissue without LE using ceMRI. The hypothesis is that compared with segments showing functional improvement, those that failed to recover had lower radial strain and lower thickness without LE and higher LE.
Detailed description
Between August 2004 and June 2006 195 patients with ischemic left ventricular dysfunction underwent MRI for the definition of myocardial viability. Onehundred-ten patients with non-ischemic cardiomyopathy or acute coronary syndromes were excluded from the study to avoid possible acute ischemia or stunning. Within the 85 patients with chronic ischemic heart disease, six patients refused participation in this study and five patients had echocardiographic windows insufficient for participation. Within the remaining 74 patients 55 patients underwent revascularization and 19 had no revascularization. These 55 patients form our study group! Functional recovery will be assessed using echocardiographic images before and 9±2 months after revascularization with a Vivid Seven System (GE Vingmed, Horton, Norway). Parasternal long-axis and short-axis views at basal, midventricular and apical levels, as well as 3 standard apical views (4 chamber, 2 chamber, and long axis) have been acquired (frame rate 56 to 92 frames/s). Segmental wall motion will be determined using the following score: 1=normokinetic, 1.5= mildly hypokinetic, 2= moderately or severely hypokinetic, 3= akinetic, or 4= dyskinetic. A segment is considered to demonstrate functional improvement during follow-up if it improved by at least 1 grade. Global functional recovery was considered in case of an increase in ejection fraction>5% at follow-up.
The three acquired parasternal short axis views will be analysed with the aid of a dedicated software package (EchoPAC BT 05.2, GE Vingmed, Horton, Norway). This system allows analysis of peak systolic circumferential and radial strain from short axis views based on detection of natural acoustic markers. The system calculates mean strain values for whole predefined LV segments, including all myocardial layers from the endocardium to epicardium.
All patients underwent cMRI within a few hours of the baseline echocardiographic study on a 1.5-T whole-body MR scanner (Intera, Best, Philips, the Netherlands). The assignment to a hyperenhancement category reflects the extent of hyperenhancement within each segment by visual assessment considering a 5-group scale: 0% hyperenhancement (group 1), 1 to 25% hyperenhancement (group 2), 26 to 50% hyperenhancement (group 3), 51 to 75% hyperenhancement (group 4) and 76 to 100% hyperenhancement (group 5).
In addition, the maximal thickness of myocardial tissue without late hyperenhancement will be determined for each LV segment. This is considered to be a parameter of the remaining viable myocardium.
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with ischemic left ventricular dysfunction scheduled for coronary revascularization
Key exclusion criteria (1 listed)
- Patients with acute coronary syndrome and poor echocardiographic windows
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 |
|---|---|---|
| Magnetic Resonance Imaging | Procedure or surgery | – |
| Revascularization | Procedure or surgery | – |
| Echocardiography with myocardial deformation imaging | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
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 22 May 2007.
- Results publication: PubMed 17035253Becker M, Hoffmann R, Kuhl HP, Grawe H, Katoh M, Kramann R, Bucker A, Hanrath P, Heussen N. Analysis of myocardial deformation based on ultrasonic pixel tracking to determine transmurality in chronic myocardial infarction. Eur Heart J. 2006 Nov;27(21):2560-6. doi: 10.1093/eurheartj/ehl288. Epub 2006 Oct 11.
- Results publication: PubMed 11078769Kim RJ, Wu E, Rafael A, Chen EL, Parker MA, Simonetti O, Klocke FJ, Bonow RO, Judd RM. The use of contrast-enhanced magnetic resonance imaging to identify reversible myocardial dysfunction. N Engl J Med. 2000 Nov 16;343(20):1445-53. doi: 10.1056/NEJM200011163432003.
- Results publication: PubMed 15163933Reisner SA, Lysyansky P, Agmon Y, Mutlak D, Lessick J, Friedman Z. Global longitudinal strain: a novel index of left ventricular systolic function. J Am Soc Echocardiogr. 2004 Jun;17(6):630-3. doi: 10.1016/j.echo.2004.02.011.
- Derived from this study: PubMed 21415076Becker M, Altiok E, Lente C, Otten S, Friedman Z, Adam D, Hoffmann R, Koos R, Krombach G, Marx N, Hoffmann R. Layer-specific analysis of myocardial function for accurate prediction of reversible ischaemic dysfunction in intermediate viability defined by contrast-enhanced MRI. Heart. 2011 May;97(9):748-56. doi: 10.1136/hrt.2010.210906. Epub 2011 Mar 17.
- Derived from this study: PubMed 18402903Becker M, Lenzen A, Ocklenburg C, Stempel K, Kuhl H, Neizel M, Katoh M, Kramann R, Wildberger J, Kelm M, Hoffmann R. Myocardial deformation imaging based on ultrasonic pixel tracking to identify reversible myocardial dysfunction. J Am Coll Cardiol. 2008 Apr 15;51(15):1473-81. doi: 10.1016/j.jacc.2007.10.066.
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.
Michael Becker, PhD, MD principal investigator
RWTH Aachen University Hospital
Rainer Hoffmann, Professor study chair
RWTH Aachen University Hospital
Malte Kelm, Professor study director
RWTH Aachen 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 Myocardial Viability in Ischemic Left Ventricular Dysfunction and Prediction for Improvement in Cardiac Function After Revascularization Therapy, run by RWTH Aachen University at 1 site in Germany.
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 1 inclusion and 1 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 22 May 2007. 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 Germany. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00476320, which also lists 5 linked publications.
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 22 May 2007.