Ventricular ArrythmiaMINERVANCT03022487
Multicentre Investigation of Novel Electrocardiogram Risk Markers in Ventricular Arrhythmia Prediction
An observational study of Ventricular Arrythmia and Ischemic Cardiomyopathy, run by University of Leicester at 8 sites in United Kingdom.
Trial summary
This is a prospective open label single blinded multi-centre observational study involving a study group of patients already undergoing implantable cardioverter-defibrillator (ICD)(including Cardiac resynchronisation therapy device (CRT-D)) implant. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Arrythmia, Ischemic Cardiomyopathy
- How many people
- 395 participants
- Where
- 8 sitesUnited Kingdom
- Study dates
- 8 Jul 2016to 30 Sep 2022
- 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: 440 patients with Ischaemic cardiomyopathy being fitted with an implantable cardioverter-defibrillator (ICDs)
Who may be able to join
- Participant is willing and able to give informed consent for participation in the study
- Male or Female, aged 18 years or above
- Female participants of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study
- Diagnosed with a history of ischaemic cardiomyopathy
- Stable, as define as no more than a 100% increase or a 50% decrease, dose of current regular medication as standard for patients at risk of ventricular arrhythmia for at least 4 weeks prior to study entry
- Able (in the Investigators opinion) and willing to comply with all study requirements
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- Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study
- Patients must be able to attend follow up at the study site until the study closure
- Attending for first time primary prevention ICD (including CRT-D) implantation under THE National Institute for Health and Care Excellence (NICE) criteria
- Patients must be able to read and understand English
- Stable dose of current regular medication for at least 4 weeks prior to study entry
Who cannot join
- Within 28 days since acute coronary syndrome/cardiac surgery
- Scheduled elective surgery or other procedures requiring general anaesthesia during the study: for example - awaiting coronary revascularisation
- Female participants who are pregnant, lactating or planning pregnancy during the course of the study
- Contraindications for electrophysiological study
- Haemodynamic instability
- Severe valvular heart disease as define by British Society of Echocardiography (BSE) guidelines
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- Symptomatic coronary artery disease (unstable or refractory angina)
- Stroke within the last 12 months
- Significant renal disease stage i.e. Chronic Kidney Disease stage 5 (requiring renal replacement therapy and / or Estimated glomerular filtration rate (eGFR) <15), or severe liver disease (end stage or presence of cirrhosis)
- Participants who have participated in another research study involving an investigational product in the past 12 weeks
- Undergone ICD implantation where the right ventricular lead is non-apically positioned e.g. positioned septally
- Clinically judged by a cardiologist to require a ventricular tachycardia (VT) therapy zone less than or equal to 200 bpm
- Any other significant disease or disorders which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study. Specific concerns should be discussed with the Chief / Co - Investigators
- Any other interventional research
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United Kingdom8 sites
Hull and East Yorkshire Hospitals NHS Trust
Cottingham
The Dudley Group NHS Foundation Trust
Dudley
Leeds Teaching Hospitals NHS Trust
Leeds
University Hospitals of Leicester NHS Trust
Leicester
Barts Health NHS Trust
London
Imperial college Healthcare NHS Trust
London
Nottingham University Hospitals NHS Trust
Nottingham
Oxford University Hospitals NHS Foundation Trust
Oxford
About this study
Official title: Multicentre Investigation of Novel Electrocardiogram Risk Markers in Ventricular Arrhythmia Prediction (MINERVA)
This is a prospective open label single blinded multi-centre observational study involving a study group of patients already undergoing implantable cardioverter-defibrillator (ICD)(including Cardiac resynchronisation therapy device (CRT-D)) implant. A standard 30-minute electrophysiological (EP) cardiac stimulation protocol will be performed at the end of the ICD implant at baseline. This EP test will be performed whilst measuring a 12-lead ECG and will be correlated with event rates to establish their effectiveness in predicting arrhythmia risk. The minimum follow up period should be 18 months and maximum of 3 years, which is how long the study is funded for. This study is not randomised as all study patients will be receiving the EP study performed at baseline. A minimum of 440 patients will be recruited to document event data at standard clinical ICD follow up intervals - equating to a maximum of 6 visits. Blinding will be maintained at the core lab were the ECG analysis will be performed by a nominated researcher who will not have details of patient health status.
- Conditions
- Ventricular Arrythmia, Ischemic Cardiomyopathy
- Keywords
- Sudden Cardiac Death (SCD), implantable cardioverter defibrillator, electrophysiological, EP, Ischaemic cardiomyopathy, Ventricular Arrhythmia, ICD
- Medical subject headings
- Death, Sudden, Cardiac
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 |
|---|---|---|
| ICD Patients with Ischaemic cardiomyopathy | A standard 30-minute electrophysiological (EP) cardiac stimulation protocol will be performed at the end of the ICD implant at baseline. Participants will be followed up for at least 12 months for endpoints. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regional Restitution Instability Index (R2I2), the mean of the standard deviation of the residuals from the mean gradients for each ECG lead across a range of diastolic intervals, will be determined from an EP study carried out at ICD implant.
- For each lead of the surface ECG, the QTpeak will be plotted as a function of TpeakQ, and gradients were fitted by using 40ms overlapping least squares linear segments as described previously by Taggart et al. [9]. For each lead, in each 40 ms segment, the difference of the gradient from the mean gradient in that 40 ms segment will be calculated. The mean of the standard deviation of these values will be taken as the R2I2.
- An R2I2 cut-off of 1.03 (no units) will partition the study population into high and low risk groups.
Measured: 12 - 36 months
Peak ECG Restitution Slope (PERS), calculated as the peak restitution curve slope taken as a mean across the 12 ECG leads .
A PERS cut-off of 1.21 (no units) will partition the study population into high and low risk groups.
Measured: 12 - 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2017 (estimated)
- Study start8 Jul 2016
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
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 Ventricular ArrythmiaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 395 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leicester
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- G. André Ng, Study chair, University of Leicester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03022487
- Sponsor's protocol ID
- 0556
- Other IDs
- 186618, 16/NI/0069
- Acronym
- MINERVA
- Status last verified
- May 2022
- First submitted
- 9 Jan 2017
- Last updated
- 5 Jan 2024
- Results posted
- No
- Individual data sharing
- No
Publications
Ng GA, Mistry A, Newton M, Schlindwein FS, Barr C, Bates MG, Caldwell J, Das M, Farooq M, Herring N, Lambiase P, Osman F, Sohal M, Staniforth A, Tayebjee M, Tomlinson D, Whinnett Z, Yue A, Nicolson WB. Rationale and study design of the MINERVA study: Multicentre Investigation of Novel Electrocardiogram Risk markers in Ventricular Arrhythmia prediction-UK multicentre collaboration. BMJ Open. 2022 Jan 3;12(1):e059527. doi: 10.1136/bmjopen-2021-059527.
PubMed 34980634
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre Investigation of Novel Electrocardiogram Risk Markers in Ventricular Arrhythmia Prediction (MINERVA)
- ClinicalTrials.gov ID
- NCT03022487
- Acronym / sponsor ID
- MINERVA / 0556
- Conditions
- Ventricular Arrythmia, Ischemic Cardiomyopathy
- Keywords
- Sudden Cardiac Death (SCD), implantable cardioverter defibrillator, electrophysiological, EP, Ischaemic cardiomyopathy, Ventricular Arrhythmia, ICD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 395 participants (actual)
- Lead sponsor
- University of LeicesterUniversity, hospital or other
- Study start
- 8 Jul 2016 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 16 Jan 2017 (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.
This is a prospective open label single blinded multi-centre observational study involving a study group of patients already undergoing implantable cardioverter-defibrillator (ICD)(including Cardiac resynchronisation therapy device (CRT-D)) implant. A standard 30-minute electrophysiological (EP) cardiac stimulation protocol will be performed at the end of the ICD implant at baseline. This EP test will be performed whilst measuring a 12-lead ECG and will be correlated with event rates to establish their effectiveness in predicting arrhythmia risk. The minimum follow up period should be 18 months and maximum of 3 years, which is how long the study is funded for. This study is not randomised as all study patients will be receiving the EP study performed at baseline. A minimum of 440 patients will be recruited to document event data at standard clinical ICD follow up intervals - equating to a maximum of 6 visits. Blinding will be maintained at the core lab were the ECG analysis will be performed by a nominated researcher who will not have details of patient health status.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICD Patients with Ischaemic cardiomyopathy | – | –A standard 30-minute electrophysiological (EP) cardiac stimulation protocol will be performed at the end of the ICD implant at baseline. Participants will be followed up for at least 12 months for endpoints. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 440 patients with Ischaemic cardiomyopathy being fitted with an implantable cardioverter-defibrillator (ICDs)
Key inclusion criteria (11 listed)
- Participant is willing and able to give informed consent for participation in the study
- Male or Female, aged 18 years or above
- Female participants of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study
- Diagnosed with a history of ischaemic cardiomyopathy
- Stable, as define as no more than a 100% increase or a 50% decrease, dose of current regular medication as standard for patients at risk of ventricular arrhythmia for at least 4 weeks prior to study entry
Key exclusion criteria (14 listed)
- Within 28 days since acute coronary syndrome/cardiac surgery
- Scheduled elective surgery or other procedures requiring general anaesthesia during the study: for example - awaiting coronary revascularisation
- Female participants who are pregnant, lactating or planning pregnancy during the course of the study
- Contraindications for electrophysiological study
- Significant renal disease stage i.e. Chronic Kidney Disease stage 5 (requiring renal replacement therapy and / or Estimated glomerular filtration rate (eGFR) <15), or severe liver disease (end stage or presence of cirrhosis)
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
Regional Restitution Instability Index (R2I2), the mean of the standard deviation of the residuals from the mean gradients for each ECG lead across a range of diastolic intervals, will be determined from an EP study carried out at ICD implant.
Time frame: 12 - 36 months
* For each lead of the surface ECG, the QTpeak will be plotted as a function of TpeakQ, and gradients were fitted by using 40ms overlapping least squares linear segments as described previously by Taggart et al. [9]. For each lead, in each 40 ms segment, the difference of the gradient from the mean gradient in that 40 ms segment will be calculated. The mean of the standard deviation of these values will be taken as the R2I2. * An R2I2 cut-off of 1.03 (no units) will partition the study population into high and low risk groups.
Peak ECG Restitution Slope (PERS), calculated as the peak restitution curve slope taken as a mean across the 12 ECG leads .
Time frame: 12 - 36 months
A PERS cut-off of 1.21 (no units) will partition the study population into high and low risk groups.
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 5 Jan 2024.
- Derived from this study: PubMed 34980634Ng GA, Mistry A, Newton M, Schlindwein FS, Barr C, Bates MG, Caldwell J, Das M, Farooq M, Herring N, Lambiase P, Osman F, Sohal M, Staniforth A, Tayebjee M, Tomlinson D, Whinnett Z, Yue A, Nicolson WB. Rationale and study design of the MINERVA study: Multicentre Investigation of Novel Electrocardiogram Risk markers in Ventricular Arrhythmia prediction-UK multicentre collaboration. BMJ Open. 2022 Jan 3;12(1):e059527. doi: 10.1136/bmjopen-2021-059527.
- Individual participant dataSharing planned: No
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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.
G. André Ng study chair
University of Leicester
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventricular Arrythmia and Ischemic Cardiomyopathy, run by University of Leicester at 8 sites in United Kingdom.
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 11 inclusion and 14 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 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United Kingdom. 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?
Regional Restitution Instability Index (R2I2), the mean of the standard deviation of the residuals from the mean gradients for each ECG lead across a range of diastolic intervals, will be determined from an EP study carried out at ICD implant. (time frame: 12 - 36 months). The study lists 2 primary outcomes in all. 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 NCT03022487, 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 5 Jan 2024.