MAGNetic QRS-Fragmentation in Patients With Myocardial InfarcTion and Moderately RedUceD Ejection Fraction

NCT01972126 | Terminated

• 1 other identifier: Magnitude
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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 recording can be used to identify a group of patients at high risk for SCD/life threatening ventricular arrhythmia.

Conditions

Acute Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• 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 .

  2 years

Study Arms (1)

AMI patients with LVEF 36% - 50%

Acute myocardial infarction patients with left ventricular ejection fraction between 36% and 50%

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead
• Medtronic: collaborator
• Medtronic Clinical Research Institute: collaborator

Study Sites (1)

Asklepios Klinik St.Georg

Hamburg, Germany

Location

Study Officials

• K.-H. Kuck, Prof.Dr.med.

  Asklepios Klinik St. Georg, Hamburg

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2013
• First Posted: October 30, 2013
• Study Start: September 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: July 3, 2025

Record last verified: 2017-11

Locations

DE (1)