An observational study in Ventricular Arrythmia and Ischemic Cardiomyopathy, sponsored by University of Leicester. Completed at 8 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-05.
Sponsored by University of Leicester · Observational
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.
1,176 studies on the registry are indexed under Cardiomyopathies; 287 are open to participants now.
This study's enrollment of 395 is above the median of 153 across 515 observational studies indexed under Cardiomyopathies.
Browse Cardiomyopathies studies →University of Leicester is the lead sponsor of 166 studies on the registry; 51 are open to participants now.
Counted across the registry records on this site, refreshed daily.
440 patients with Ischaemic cardiomyopathy being fitted with an implantable cardioverter-defibrillator (ICDs)
Exclusion Criteria:
Contraindications for electrophysiological study
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.
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.
Time frame: 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.
Time frame: 12 - 36 months
Plan to share: No
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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University of Leicester