Acute Myocardial InfarctionMAGNITUDENCT01972126
MAGNetic QRS-Fragmentation in Patients With Myocardial InfarcTion and Moderately RedUceD Ejection Fraction
An observational study of Acute Myocardial Infarction, run by Medtronic Cardiac Rhythm and Heart Failure at 1 site in Germany.
Trial summary
The MAGNetic QRS-Fragmentation in Patients with Myocardial InfarcTion and Moderately RedUceD Ejection Fraction (MAGNITUDE) study will assess in MI survivors with moderately reduced left ventricular function, whether non-invasive MFI QRS Fragmentation alone or in combination with parameters derived from a Holter… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myocardial Infarction
- How many people
- 9 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2013to Aug 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with acute MI and LVEF between 36% and 50%, and QRS Fragmentation assessed by MFI within 3 to 10 days post-MI
Who may be able to join
- Patients must provide written informed consent/data release consent to participate in the study
- Acute Myocardial Infarction (STEMI or non-STEMI) within the last 3-10 days matching the following criteria: Rise and/or fall of Troponin (I or T) or cardiac specific creatine kinase (CK-MB) with at least one value above the 99th percentile of the upper reference limit measured plus at least one of the following:
- Chest pain ≥ 20 minutes
- ST-segment elevation of > 0.1mV in two or more limb leads or > 0.2 mV in two or more contiguous precordial leads or new left bundle branch block (LBBB) in the ECG
- Development of new pathological Q waves in the ECG
- LVEF = 36%-50% as measured by standard diagnostic methods used at the center
- MFI assessment, acquired or planned with the BMDSys Apollo CXS system
Who cannot join
- Age < 18 years
- Legally incapacitated
- Contraindication for MFI measurement:
- Pre-existing electrically active implant
- Required electrical external support systems that cannot be removed for the MFI scan
- Other disease; likely to limit survival to less than the minimal study duration (12 months)
- Participation in another investigational study with known or suspected cardiac effect expected to confound the results of this study (e.g. Stem cell trials, stent trials, cardiac intervention trials)
- Existing ICD or pacemaker indication
Trial locations and contacts
1 site in 1 country.
About this study
The MAGNetic QRS-Fragmentation in Patients with Myocardial InfarcTion and Moderately RedUceD Ejection Fraction (MAGNITUDE) study will assess in MI survivors with moderately reduced left ventricular function, whether non-invasive MFI QRS Fragmentation alone or in combination with parameters derived from a Holter recording can be used to identify a group of patients at high risk for SCD/life threatening ventricular arrhythmia.
Read the detailed description
Cardiac disease is the most common cause of natural death in the Western hemisphere. Half of cardiac deaths are sudden, arrhythmic. Myocardial infarction (MI) survivors have a four to five-fold higher risk of SCD compared to persons without a history of MI. Current risk assessment approaches fail to identify the majority of patients at risk of sudden, arrhythmic death. Given these facts, this patient population represents a relevant proportion of the total population at risk of developing sudden death and is currently not indicated for preventive therapy. The post-MI population with moderate LV function, specifically with a Left Ventricular Ejection Fraction (LVEF) between 35% and 50%, is therefore an appropriate group in which to assess SCD prevention strategies. It has been shown that an increased QRS fragmentation assessed by Magnetic Field Imaging (MFI) correlates with a higher incidence of arrhythmic deaths. MAGNITUDE is a prospective, multicenter, non-interventional, observational cohort study, which will provide detailed information about event rates and MFI threshold for the prediction of SCD/life threatening cardiac arrhythmic events. Target enrollment is 1000 patients, but enrollment may be extended until minimally 24 events are accrued (with a maximum of 1500 patients). All patients will be followed until at least 12 months after enrollment closure, but follow-up duration may be extended until minimally 40 events are accrued. Interim analysis will be performed after 10, 20 and 30 events, and also after 40 events if this milestone is reached 6 months or more before end of follow-up. Final analysis will be done at end of follow-up.
- Conditions
- Acute Myocardial Infarction
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 |
|---|---|---|
| AMI patients with LVEF 36% - 50% | Acute myocardial infarction patients with left ventricular ejection fraction between 36% and 50% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Value of the QRS Fragmentation Index measured by MFI analysis for determination of SCD risk
To assess the value of the QRS Fragmentation Index (FI) measured by MFI analysis for determination of SCD risk in acute MI patients with LVEF between 36% and 50%, as expressed by sensitivity using a cut-off FI ≥ 1.2 .
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2013 (estimated)
- Study startSep 2013
- Primary completionAug 2014
- Study completionAug 2014
Why it stopped: Manufacturer of the MFI QRS Fragmentation Systems used in the study, has filed for insolvency
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Medtronic Cardiac Rhythm and Heart FailureThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medtronic, Medtronic Clinical Research Institute
- Responsible party
- Sponsor
- Investigators
- K.-H. Kuck, Prof.Dr.med., Study chair, Asklepios Klinik St. Georg, Hamburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01972126
- Sponsor's protocol ID
- Magnitude
- Acronym
- MAGNITUDE
- Status last verified
- Nov 2017
- First submitted
- 24 Oct 2013
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MAGNetic QRS-Fragmentation in Patients With Myocardial InfarcTion and Moderately RedUceD Ejection Fraction
- ClinicalTrials.gov ID
- NCT01972126
- Acronym / sponsor ID
- MAGNITUDE / Magnitude
- Conditions
- Acute Myocardial Infarction
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Manufacturer of the MFI QRS Fragmentation Systems used in the study, has filed for insolvency
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Collaborators
- Medtronic, Medtronic Clinical Research Institute
- Study start
- Sep 2013 (actual)
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 30 Oct 2013 (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 MAGNetic QRS-Fragmentation in Patients with Myocardial InfarcTion and Moderately RedUceD Ejection Fraction (MAGNITUDE) study will assess in MI survivors with moderately reduced left ventricular function, whether non-invasive MFI QRS Fragmentation alone or in combination with parameters derived from a Holter recording can be used to identify a group of patients at high risk for SCD/life threatening ventricular arrhythmia.
Detailed description
Cardiac disease is the most common cause of natural death in the Western hemisphere. Half of cardiac deaths are sudden, arrhythmic. Myocardial infarction (MI) survivors have a four to five-fold higher risk of SCD compared to persons without a history of MI. Current risk assessment approaches fail to identify the majority of patients at risk of sudden, arrhythmic death. Given these facts, this patient population represents a relevant proportion of the total population at risk of developing sudden death and is currently not indicated for preventive therapy. The post-MI population with moderate LV function, specifically with a Left Ventricular Ejection Fraction (LVEF) between 35% and 50%, is therefore an appropriate group in which to assess SCD prevention strategies. It has been shown that an increased QRS fragmentation assessed by Magnetic Field Imaging (MFI) correlates with a higher incidence of arrhythmic deaths. MAGNITUDE is a prospective, multicenter, non-interventional, observational cohort study, which will provide detailed information about event rates and MFI threshold for the prediction of SCD/life threatening cardiac arrhythmic events. Target enrollment is 1000 patients, but enrollment may be extended until minimally 24 events are accrued (with a maximum of 1500 patients). All patients will be followed until at least 12 months after enrollment closure, but follow-up duration may be extended until minimally 40 events are accrued. Interim analysis will be performed after 10, 20 and 30 events, and also after 40 events if this milestone is reached 6 months or more before end of follow-up. Final analysis will be done at end of follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AMI patients with LVEF 36% - 50% | – | –Acute myocardial infarction patients with left ventricular ejection fraction between 36% and 50% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with acute MI and LVEF between 36% and 50%, and QRS Fragmentation assessed by MFI within 3 to 10 days post-MI
Key inclusion criteria (7 listed)
- Patients must provide written informed consent/data release consent to participate in the study
- Acute Myocardial Infarction (STEMI or non-STEMI) within the last 3-10 days matching the following criteria: Rise and/or fall of Troponin (I or T) or cardiac specific creatine kinase (CK-MB) with at least one value above the 99th percentile of the upper reference limit measured plus at least one of the following:
- LVEF = 36%-50% as measured by standard diagnostic methods used at the center
- MFI assessment, acquired or planned with the BMDSys Apollo CXS system
Key exclusion criteria (8 listed)
- Age < 18 years
- Legally incapacitated
- Contraindication for MFI measurement:
- Other disease; likely to limit survival to less than the minimal study duration (12 months)
- Participation in another investigational study with known or suspected cardiac effect expected to confound the results of this study (e.g. Stem cell trials, stent trials, cardiac intervention trials)
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
Value of the QRS Fragmentation Index measured by MFI analysis for determination of SCD risk
Time frame: 2 years
To assess the value of the QRS Fragmentation Index (FI) measured by MFI analysis for determination of SCD risk in acute MI patients with LVEF between 36% and 50%, as expressed by sensitivity using a cut-off FI ≥ 1.2 .
Results and safety
The study was stopped early (reason given: Manufacturer of the MFI QRS Fragmentation Systems used in the study, has filed for insolvency). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
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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.
K.-H. Kuck, Prof.Dr.med. study chair
Asklepios Klinik St. Georg, Hamburg
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 Medtronic Cardiac Rhythm and Heart Failure 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 7 inclusion and 8 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: stopped early, as of the sponsor's last update on 3 Jul 2025. 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 was stopped early (reason given: Manufacturer of the MFI QRS Fragmentation Systems used in the study, has filed for insolvency). Results are not available in the source record.
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?
Value of the QRS Fragmentation Index measured by MFI analysis for determination of SCD risk (time frame: 2 years). 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 3 Jul 2025.