ClinicalTrials.gov
ClinicalTrials.gov Menu

Utilising Lifemap to Investigate Malignant Arrhythmia Therapy (ULTIMATE)

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: NCT02058771
Recruitment Status : Recruiting
First Posted : February 10, 2014
Last Update Posted : May 30, 2017
Sponsor:
Collaborator:
University of Leicester
Information provided by (Responsible Party):
University Hospitals, Leicester

Brief 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 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:

  1. R2I2 is predictive of ventricular arrhythmia (VA) / SCD in patients with ICM.
  2. 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:

  1. 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.
  2. Serial measurement of R2I2 will produce consistent values.

Condition or disease
Ischemic Cardiomyopathy Sudden Cardiac Death Implantable Defibrillator User Myocardial Infarction Arrhythmias, Cardiac

Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: ULTIMATE: Utilising Lifemap to Investigate Malignant Arrhythmia ThErapy
Study Start Date : October 2013
Estimated Primary Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiomyopathy

Group/Cohort
Ischaemic cardiomyopathy
Patients with ischaemic cardiomyopathy attending for ICD implantation



Primary Outcome Measures :
  1. Ventricular arrhythmia/Sudden cardiac death [ Time Frame: 18 months ]

Secondary Outcome Measures :
  1. Syncope [ Time Frame: 18 months ]
  2. All cause mortality [ Time Frame: 18 months ]

Biospecimen Retention:   Samples Without DNA
Fresh Frozen Plasma


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.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with ischaemic cardiomyopathy attending for ICD implantation
Criteria

Inclusion Criteria:

  • Age >18
  • History of ischaemic cardiomyopathy

Exclusion Criteria:

  • Unable to give informed consent
  • <28 days since cardiac surgery or acute coronary syndrome

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): NCT02058771


Contacts
Contact: M. Shoaib Siddiqui, MBBS +44 116 258 3643 mss33@le.ac.uk
Contact: Will B Nicolson, MBChB wbn1@le.ac.uk

Locations
United Kingdom
NIHR Leicester Cardiovascular Biomedical Research Unit Recruiting
Leicester, United Kingdom, LE3 9QP
Contact: M. Shoaib Siddiqui, MBBS    +44 116 258 3643    mss33@le.ac.uk   
Principal Investigator: G. Andre Ng, MBChB, PhD         
Sub-Investigator: Will B Nicoloson, MBChB         
Sub-Investigator: M. Shoaib Siddiqui, MBBS         
Sponsors and Collaborators
University Hospitals, Leicester
University of Leicester
Investigators
Principal Investigator: G. Andre Ng, MBChB, PhD University of Leicester

Responsible Party: University Hospitals, Leicester
ClinicalTrials.gov Identifier: NCT02058771     History of Changes
Other Study ID Numbers: UHL10824: ULTIMATE
First Posted: February 10, 2014    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017

Keywords provided by University Hospitals, Leicester:
Action potential duration restitution
Ventricular arrhythmia
Sudden cardiac death
Body-surface potential mapping
Electrocardiogram

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Cardiomyopathies
Death
Death, Sudden, Cardiac
Arrhythmias, Cardiac
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Heart Arrest
Death, Sudden