Ischemic CardiomyopathyULTIMATENCT02058771
Utilising Lifemap to Investigate Malignant Arrhythmia Therapy
An observational study of Ischemic Cardiomyopathy and Sudden Cardiac Death, run by University Hospitals, Leicester at 1 site in United Kingdom.
Trial summary
It is universally recognised that current methods for risk stratification of sudden cardiac death (SCD) are limited. A novel SCD risk marker, the Regional Restitution Instability Index (R2I2), measures the degree of heterogeneity in electrical restitution using data obtained from a standard 12 lead ECG acquired during… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ischemic Cardiomyopathy, Sudden Cardiac Death, Implantable Defibrillator User
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2013to Nov 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with ischaemic cardiomyopathy attending for ICD implantation
Who may be able to join
- Age >18
- History of ischaemic cardiomyopathy
Who cannot join
- Unable to give informed consent
- <28 days since cardiac surgery or acute coronary syndrome
Trial locations and contacts
1 site in 1 country.
Will B Nicolson, MBChB contact
United Kingdom1 site, 1 recruiting
- Recruiting
NIHR Leicester Cardiovascular Biomedical Research Unit
Leicester, LE3 9QP
M. Shoaib Siddiqui, MBBS, +44 116 258 3643, mss33@le.ac.uk
G. Andre Ng, MBChB, PhD
About this study
Official title: ULTIMATE: Utilising Lifemap to Investigate Malignant Arrhythmia ThErapy
It is universally recognised that current methods for risk stratification of sudden cardiac death (SCD) are limited. A novel SCD risk marker, the Regional Restitution Instability Index (R2I2), measures the degree of heterogeneity in electrical restitution using data obtained from a standard 12 lead ECG acquired during an invasive electrophysiological study.
In an ischaemic cardiomyopathy (ICM) cohort of 66 patients, an R2I2 of ≥1.03 identified subjects with a significantly higher risk of ventricular arrhythmia (VA) or death (43%) compared with those with an R2I2 <1.03 (11%) (P=0.004).
Read more
This study will use non-invasive techniques to acquire electrical restitution data: exercise and pharmacological stress, and will incorporate body surface potential mapping to develop a non-invasive and high-resolution form of R2I2. Suitable patients will be recruited into a prospective, observational study.
HYPOTHESES:
PRIMARY:
- R2I2 is predictive of ventricular arrhythmia (VA) / SCD in patients with ICM.
- The exercise stress protocol will create a dynamic range of heart rates that allows ECG quantification of electrical restitution heterogeneity that correlates with invasive R2I2 and is predictive of VA/SCD. The pharmacological stress protocol will create a dynamic range of heart rates that allows ECG based quantification of electrical restitution heterogeneity that correlates with invasive R2I2 and is predictive of VA/SCD.
SECONDARY:
- A high-resolution electrical map acquired using body surface potential mapping will correlate with R2I2 and these data can be included in the R2I2 calculation to improve its prediction of SCD/VA.
- Serial measurement of R2I2 will produce consistent values.
- Conditions
- Ischemic Cardiomyopathy, Sudden Cardiac Death, Implantable Defibrillator User, Myocardial Infarction, Arrhythmias, Cardiac
- Keywords
- Action potential duration restitution, Ventricular arrhythmia, Sudden cardiac death, Body-surface potential mapping, Electrocardiogram
- Medical subject headings
- Death, Sudden, Cardiac, Myocardial Infarction, Arrhythmias, 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 |
|---|---|---|
| Ischaemic cardiomyopathy | Patients with ischaemic cardiomyopathy attending for ICD implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventricular arrhythmia/Sudden cardiac death
Measured: 18 months
Secondary outcomes (2)
Syncope
Measured: 18 months
All cause mortality
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2014 (estimated)
- Study startOct 2013
- Primary completionNov 2022 (estimated)
- Study completionNov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic CardiomyopathyStudies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospitals, Leicester
- Sponsor type
- University, hospital or other
- Collaborators
- University of Leicester
- Responsible party
- Sponsor
- Investigators
- G. Andre Ng, MBChB, PhD, Principal investigator, University of Leicester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02058771
- Sponsor's protocol ID
- UHL10824: ULTIMATE
- Acronym
- ULTIMATE
- Status last verified
- Nov 2020
- First submitted
- 6 Feb 2014
- Last updated
- 9 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ULTIMATE: Utilising Lifemap to Investigate Malignant Arrhythmia ThErapy
- ClinicalTrials.gov ID
- NCT02058771
- Acronym / sponsor ID
- ULTIMATE / UHL10824: ULTIMATE
- Conditions
- Ischemic Cardiomyopathy, Sudden Cardiac Death, Implantable Defibrillator User, Myocardial Infarction, Arrhythmias, Cardiac
- Keywords
- Action potential duration restitution, Ventricular arrhythmia, Sudden cardiac death, Body-surface potential mapping, Electrocardiogram
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospitals, LeicesterUniversity, hospital or other
- Collaborators
- University of Leicester
- Study start
- Oct 2013
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 10 Feb 2014 (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.
It is universally recognised that current methods for risk stratification of sudden cardiac death (SCD) are limited. A novel SCD risk marker, the Regional Restitution Instability Index (R2I2), measures the degree of heterogeneity in electrical restitution using data obtained from a standard 12 lead ECG acquired during an invasive electrophysiological study.
In an ischaemic cardiomyopathy (ICM) cohort of 66 patients, an R2I2 of ≥1.03 identified subjects with a significantly higher risk of ventricular arrhythmia (VA) or death (43%) compared with those with an R2I2 <1.03 (11%) (P=0.004).
This study will use non-invasive techniques to acquire electrical restitution data: exercise and pharmacological stress, and will incorporate body surface potential mapping to develop a non-invasive and high-resolution form of R2I2. Suitable patients will be recruited into a prospective, observational study.
HYPOTHESES:
PRIMARY:
- R2I2 is predictive of ventricular arrhythmia (VA) / SCD in patients with ICM.
- The exercise stress protocol will create a dynamic range of heart rates that allows ECG quantification of electrical restitution heterogeneity that correlates with invasive R2I2 and is predictive of VA/SCD. The pharmacological stress protocol will create a dynamic range of heart rates that allows ECG based quantification of electrical restitution heterogeneity that correlates with invasive R2I2 and is predictive of VA/SCD.
SECONDARY:
- A high-resolution electrical map acquired using body surface potential mapping will correlate with R2I2 and these data can be included in the R2I2 calculation to improve its prediction of SCD/VA.
- Serial measurement of R2I2 will produce consistent values.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ischaemic cardiomyopathy | – | –Patients with ischaemic cardiomyopathy attending for ICD implantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with ischaemic cardiomyopathy attending for ICD implantation
Key inclusion criteria (2 listed)
- Age >18
- History of ischaemic cardiomyopathy
Key exclusion criteria (2 listed)
- Unable to give informed consent
- <28 days since cardiac surgery or acute coronary syndrome
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
Ventricular arrhythmia/Sudden cardiac death
Time frame: 18 months
2 secondary outcomes
Syncope
Time frame: 18 months
All cause mortality
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2020.
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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.
Will B Nicolson, MBChB contact
G. Andre Ng, MBChB, PhD principal investigator
University of Leicester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Cardiomyopathy and Sudden Cardiac Death, run by University Hospitals, Leicester at 1 site 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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 9 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact M. Shoaib Siddiqui, MBBS (+44 116 258 3643, mss33@le.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ventricular arrhythmia/Sudden cardiac death (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Nov 2020.