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

NCT04352816 | Active Not Recruiting DMC

• 1 other identifier: FO401218
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

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.

Conditions

Death, Sudden, Cardiac; Ventricular Arrythmia

Outcome Measures

Primary Outcomes (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

  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.

  12-72 months

Secondary Outcomes (4)

• Exploring the correlation of MCG QRS fragmentation and current flow analysis with ICD therapies

  12-72 months

• Exploring the correlation between ECG parameters, Echo findings, MCG parameters and ICD therapies.

  12-72 months

• Correlation of MCG parameters with Left ventricular ejection fraction (LVEF)

  Baseline

• Analysis of the SF-36 quality of life questionnaire results

  12 month follow up

Study Arms (3)

Control Group

EXPERIMENTAL

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

Observation group

EXPERIMENTAL

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

Device in situ group

EXPERIMENTAL

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

Interventions

Magnetocardiogram DEVICE

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.

Control Group; Device in situ group; Observation group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• University Hospitals Coventry and Warwickshire NHS Trust: lead

Study Sites (1)

University Hospital Coventry and Warwickshire NHS Trust

Coventry, West Midlands, CV22DX, United Kingdom

Location

Related Publications (1)

• Lachlan T, He H, Sharma K, Khan J, Rajappan K, Morley-Davies A, Patwala A, Randeva H, Osman F. MAGNETO cardiography parameters to predict future Sudden Cardiac Death (MAGNETO-SCD) or ventricular events from implantable cardioverter defibrillators: study protocol, design and rationale. BMJ Open. 2020 Oct 10;10(10):e038804. doi: 10.1136/bmjopen-2020-038804.

  PMID: 33040013 DERIVED

MeSH Terms

Conditions

Death, Sudden, Cardiac

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Cardiovascular Diseases; Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Faizel Osman, MD FRCP FESC

  university Hospital Coventry and Warwickshire

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2019
• First Posted: April 20, 2020
• Study Start: August 9, 2019
• Primary Completion: November 17, 2021
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 18, 2024

Record last verified: 2024-06

Locations

GB (1)