Acute Myocardial Infarction137-2005NCT00752713
Strain-Encoded Magnetic Resonance Imaging in Acute Myocardial Infarction
An observational study of Acute Myocardial Infarction, run by RWTH Aachen University at 1 site in Germany.
Trial summary
The aim of the study was therefore to evaluate whether myocardial deformation imaging performed by SENC allows for quantification of regional left ventricular function and is related to transmurality states of infarcted tissue in patients with acute myocardial infarction (AMI). Read more about this study
- Who is it for?
- Ages 30 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- cardiac MRI
- Type of treatment
- Surgery or procedure
- How many people
- 48 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2007to Jan 2008
- 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 30 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: * Consecutive Patients with AMI 3+/-1 days after successful reperfusion * Ten healthy volunteers serving as control group
Who may be able to join
- Patients with AMI after successful reperfusion
- Healthy volunteers in control group
Who cannot join
- No reperfusion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Strain-Encoded Magnetic Resonance Imaging for Evaluation of Left Ventricular Function and Acute Myocardial Infarction
The aim of the study was therefore to evaluate whether myocardial deformation imaging performed by SENC allows for quantification of regional left ventricular function and is related to transmurality states of infarcted tissue in patients with acute myocardial infarction (AMI).
Read the detailed description
CMR was performed in 38 consecutive patients with AMI 3±1 days after successful reperfusion using a clinical 1.5 Tesla MR-scanner. Ten healthy volunteers served as controls. SENC is a technique that directly measures peak circumferential strain from long-axis views and peak longitudinal strain from short axis views. Measurements were obtained for each segment in a modified 17 segment model. Wall motion and infarcted tissue were evaluated semi-quantitatively from SSFP cine sequences and contrast-enhanced-MR-images and were then related to myocardial strain. Comparison of peak circumferential strain assessed by SENC and MR-tagging was performed.
- Conditions
- Acute Myocardial Infarction
- Being tested
- cardiac MRI
- Keywords
- AMI,, Reperfusion, successful
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiac MRIProcedure or surgery
Also called cardiac resonance magnetic imaging
cardiac MRI at one time point for group 1 after intervention for group 2 at any time point
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients presenting to hospital with AMI Receives: Procedure: cardiac MRI | |
| 2 | healthy volunteers as control group Receives: Procedure: cardiac MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular function
Measured: 01.01.2007 until 01.02.2007
Secondary outcomes (1)
Transmurality
Measured: 01.01.2007 until 01.02.2007
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2008 (estimated)
- Study startJan 2007
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Myocardial InfarctionStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Collaborators
- Heidelberg University
- Investigators
- Mirja Neizel, MD, Principal investigator, University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00752713
- Sponsor's protocol ID
- SENC in AMI
- Acronym
- 137-2005
- Status last verified
- Sep 2008
- First submitted
- 11 Sep 2008
- Last updated
- 16 Sep 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Neizel M, Korosoglou G, Lossnitzer D, Kuhl H, Hoffmann R, Ocklenburg C, Giannitsis E, Osman NF, Katus HA, Steen H. Impact of systolic and diastolic deformation indexes assessed by strain-encoded imaging to predict persistent severe myocardial dysfunction in patients after acute myocardial infarction at follow-up. J Am Coll Cardiol. 2010 Sep 21;56(13):1056-62. doi: 10.1016/j.jacc.2010.02.070.
PubMed 20846606
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strain-Encoded Magnetic Resonance Imaging for Evaluation of Left Ventricular Function and Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT00752713
- Acronym / sponsor ID
- 137-2005 / SENC in AMI
- Conditions
- Acute Myocardial Infarction
- Keywords
- AMI,, Reperfusion, successful
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Collaborators
- Heidelberg University
- Study start
- Jan 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 15 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.
The aim of the study was therefore to evaluate whether myocardial deformation imaging performed by SENC allows for quantification of regional left ventricular function and is related to transmurality states of infarcted tissue in patients with acute myocardial infarction (AMI).
Detailed description
CMR was performed in 38 consecutive patients with AMI 3±1 days after successful reperfusion using a clinical 1.5 Tesla MR-scanner. Ten healthy volunteers served as controls. SENC is a technique that directly measures peak circumferential strain from long-axis views and peak longitudinal strain from short axis views. Measurements were obtained for each segment in a modified 17 segment model. Wall motion and infarcted tissue were evaluated semi-quantitatively from SSFP cine sequences and contrast-enhanced-MR-images and were then related to myocardial strain. Comparison of peak circumferential strain assessed by SENC and MR-tagging was performed.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Procedure: cardiac MRIPatients presenting to hospital with AMI |
| 2 | – | Procedure: cardiac MRIhealthy volunteers as control group |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- * Consecutive Patients with AMI 3+/-1 days after successful reperfusion * Ten healthy volunteers serving as control group
Key inclusion criteria (2 listed)
- Patients with AMI after successful reperfusion
- Healthy volunteers in control group
Key exclusion criteria (1 listed)
- No reperfusion
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 |
|---|---|---|
| cardiac MRIAlso: cardiac resonance magnetic imagingcardiac MRI at one time point for group 1 after intervention for group 2 at any time point | Procedure or surgery | 1, 2 |
Primary outcome
Left ventricular function
Time frame: 01.01.2007 until 01.02.2007
1 secondary outcome
Transmurality
Time frame: 01.01.2007 until 01.02.2007
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 16 Sep 2008.
- Derived from this study: PubMed 20846606Neizel M, Korosoglou G, Lossnitzer D, Kuhl H, Hoffmann R, Ocklenburg C, Giannitsis E, Osman NF, Katus HA, Steen H. Impact of systolic and diastolic deformation indexes assessed by strain-encoded imaging to predict persistent severe myocardial dysfunction in patients after acute myocardial infarction at follow-up. J Am Coll Cardiol. 2010 Sep 21;56(13):1056-62. doi: 10.1016/j.jacc.2010.02.070.
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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.
Mirja Neizel, MD principal investigator
University Hospital Heidelberg
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 Acute Myocardial Infarction, 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 2 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 16 Sep 2008. 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.
What does the primary outcome measure?
Left ventricular function (time frame: 01.01.2007 until 01.02.2007). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00752713, which also lists 1 linked publication.
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 16 Sep 2008.