Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Magnetocardiography (MCG) Parameters in the Prediction of Future ICD Therapy (Magneto-SCD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04352816
Recruitment Status : Recruiting
First Posted : April 20, 2020
Last Update Posted : November 8, 2021
Sponsor:
Information provided by (Responsible Party):
University Hospitals Coventry and Warwickshire NHS Trust

Brief Summary:
A multi-centre observational cohort trial to identify Magnetocardiography (MCG) parameters in the prediction of future ICD therapy. To show a correlation between Arrhythmogenic features on MCG and future ICD therapies seen on ICD interrogation of patients at risk of SCD.

Condition or disease Intervention/treatment Phase
Death, Sudden, Cardiac Ventricular Arrythmia Device: Magnetocardiogram Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 510 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Multi-centre Observational Cohort Trial to Identify Magnetocardiography (MCG) Parameters in the Prediction of Future ICD Therapy
Actual Study Start Date : August 9, 2019
Estimated Primary Completion Date : November 18, 2021
Estimated Study Completion Date : December 31, 2026

Arm Intervention/treatment
Experimental: Control Group
Participants who do not receive an ICD therapy and have normal Echocardiogram findings and no evidence of arrhythmia will form this group. These participants will receive an MCG scan in addition to their standard care plan We will record the findings of any/all investigations participants receive as per their standard care plan, such as imaging providing left ventricular ejection fraction and usual care blood tests although their research activity/involvement in the trial will cease after the baseline observation. There will be no follow up. We aim to recruit 210 participants to this group to match the anticipated size of the group who receive an ICD but don't receive a shock.
Device: Magnetocardiogram
Magnetocardiography (MCG) is a non-invasive, non-contact body-surface method which uses magnetometers to measure and map the magnetic fields generated by the electrical activity within the heart. It offers a better spatial resolution than an ECG recording and opens the possibility of detecting conduction characteristics consistent with arrhythmogenesis.9-15 The application of MCG has been limited by feasibility as devices up to now have been based on superconducting quantum interference devices (SQUID) with supercooled sensors. These machines were often operated in a shielded environment, to decrease magnetic field interference (noise) from electrical devices and other sources of magnetic fields. This was a major limiting factor in deploying these devices in a working environment especially considering, that most hospital wards will have numerous devices that can interfere with the device.

Experimental: Observation group
The participants who go on to receive an ICD therapy, as part of standard care, will constitute the 'Observation' group. These participants will undergo an MCG, lying and standing blood pressure and undertake a quality of life questionnaire. Participants in this group will undergo additional blood tests, circulating vascular biomarkers such as (High sensitivity Troponin, Nt pro BNP, CRP, High sensitivity CRP, mRNA, IL-6). All scans and tests that are conducted as part of standard care for evaluation of requirement of ICD implantation will be collected, for example; Echocardiographic, CMRI or MUGA measurements of the heart chambers and function. We will record these findings as this will enable us to substratify patients according to different degrees of cardiac dysfunction
Device: Magnetocardiogram
Magnetocardiography (MCG) is a non-invasive, non-contact body-surface method which uses magnetometers to measure and map the magnetic fields generated by the electrical activity within the heart. It offers a better spatial resolution than an ECG recording and opens the possibility of detecting conduction characteristics consistent with arrhythmogenesis.9-15 The application of MCG has been limited by feasibility as devices up to now have been based on superconducting quantum interference devices (SQUID) with supercooled sensors. These machines were often operated in a shielded environment, to decrease magnetic field interference (noise) from electrical devices and other sources of magnetic fields. This was a major limiting factor in deploying these devices in a working environment especially considering, that most hospital wards will have numerous devices that can interfere with the device.

Experimental: Device in situ group

To achieve the secondary objectives of exploring whether features consistent with arrhythmogenesis are extractable from MCG scans on participants with ICDS and pacemakers in situ, the investigators will recruit an additional 30 participants separate from the main trial. Twenty participants will be recruited from the ICD clinic. These participants, who have already had an ICD implanted will be selected with a 50:50 split as to whether they have had previous therapy from the ICD. The presence of an ICD can impact the analysis of MCGs in these patients due to the background signal noise subtraction required to obtain a usable signal. We will use these scans to trial different signal noise reduction strategies. These will be analysed to determine whether the features seen in the main trial can be extracted from this data set.

10 participants will be recruited who have got an upgrade from a pacemaker to an ICD.

Device: Magnetocardiogram
Magnetocardiography (MCG) is a non-invasive, non-contact body-surface method which uses magnetometers to measure and map the magnetic fields generated by the electrical activity within the heart. It offers a better spatial resolution than an ECG recording and opens the possibility of detecting conduction characteristics consistent with arrhythmogenesis.9-15 The application of MCG has been limited by feasibility as devices up to now have been based on superconducting quantum interference devices (SQUID) with supercooled sensors. These machines were often operated in a shielded environment, to decrease magnetic field interference (noise) from electrical devices and other sources of magnetic fields. This was a major limiting factor in deploying these devices in a working environment especially considering, that most hospital wards will have numerous devices that can interfere with the device.




Primary Outcome Measures :
  1. Number of participants with features of heterogenous myocardial conduction (eg. late QRS signals, QT dispersion) and correlation with ventricular arrhythmias as reported by ICD interrogation [ Time Frame: 12-72 months ]
    We will remotely follow up participants who have had ICD and observe if they have had an ICD interrogation (Shock) for arrythmogenic events. These are defined by ventricular rates that are faster than 149 beats per minute and deemed to be ventricular in origin on ICD interrogation during standard follow up. We will the compare the MCG scans of participants who had shock with that of whom did not.


Secondary Outcome Measures :
  1. Exploring the correlation of MCG QRS fragmentation and current flow analysis with ICD therapies [ Time Frame: 12-72 months ]

    Outcome measures - ICD therapies: ICD interrogation (Shock) for arrythmogenic events. These are defined by ventricular rates that are faster than 149 beats per minute and deemed to be ventricular in origin on ICD interrogation during standard follow up.

    MCG: QRS fragmentation as defined by waveform extrema and amplitude in normalised MCG waveform.

    Current flow analysis is derived from MCG field maps and is perpendicular to the magnetic field.


  2. Exploring the correlation between ECG parameters, Echo findings, MCG parameters and ICD therapies. [ Time Frame: 12-72 months ]

    Outcome measures - ICD therapies: ICD interrogation (Shock) for arrythmogenic events. These are defined by ventricular rates that are faster than 149 beats per minute and deemed to be ventricular in origin on ICD interrogation during standard follow up.

    ECG parameters: QRS width

    Echo parameters: Left Ventricular Ejection Fraction - categorised into participants with severely impaired systolic function (LVEF<35%) or those without (LVEF>35%)

    MCG parameters: Features of heterogenous conduction (eg. late QRS signals, QT dispersion)


  3. Correlation of MCG parameters with Left ventricular ejection fraction (LVEF) [ Time Frame: Baseline ]

    LVEF as determined by Echo or CMRI expressed as % change in LV volume during cardiac cycle

    MCG parameters: Features of heterogenous conduction (eg. late QRS signals, QT dispersion)


  4. Analysis of the SF-36 quality of life questionnaire results [ Time Frame: 12 month follow up ]

    Evaluate the responses to a SF-36 quality of life questionnaire to document the tolerability of ICD implantation and therapy.

    Comparisons will be made between responses from those participants who have received therapy from their device and those who haven't and between those participants who have a primary or secondary indication for their device.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All patients referred to the cardiology team who meet the following criteria will be invited to participate in the trial:
  • Age: 18 years or over
  • Can give informed consent

Exclusion Criteria:

  • - Patients unable to lie still on a bed at a maximum of 30 degree angle for 5 minutes
  • Patients with ongoing myocardial infarction or active ischaemia.
  • Clinically unstable patients as determined by their treating clinician.
  • Patients with existing thoracic metallic implants ie. pacing or defibrillator device, metallic valve will be excluded from the main arm of the trial. The research team will perform a side arm (Device in situ group) trial on 30 participants with either ICDs or pacemakers.
  • Age: Under 18 years.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04352816


Contacts
Layout table for location contacts
Contact: Kavi Sharma 02476966197 kavi.sharma@uhcw.nhs.uk
Contact: Sonia Kandola, MD 02476 966195 Sonia.Kandola@uhcw.nhs.uk

Locations
Layout table for location information
United Kingdom
University Hospital Coventry and Warwickshire NHS Trust Recruiting
Coventry, West Midlands, United Kingdom, CV22DX
Contact: Kavi Sharma, MD    2476966197    kavi.sharma@uhcw.nhs.uk   
Contact: Shivam Joshi    02476 966907    shivam.joshi@uhcw.nhs.uk   
Sub-Investigator: Thomas Lochlan         
Sponsors and Collaborators
University Hospitals Coventry and Warwickshire NHS Trust
Investigators
Layout table for investigator information
Principal Investigator: Faizel Osman, MD FRCP FESC university Hospital Coventry and Warwickshire
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: University Hospitals Coventry and Warwickshire NHS Trust
ClinicalTrials.gov Identifier: NCT04352816    
Other Study ID Numbers: FO401218
First Posted: April 20, 2020    Key Record Dates
Last Update Posted: November 8, 2021
Last Verified: November 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Death, Sudden, Cardiac
Death, Sudden
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Death
Heart Arrest