NCT02058771

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. 1.R2I2 is predictive of ventricular arrhythmia (VA) / SCD in patients with ICM.
  2. 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.
  3. 3.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.
  4. 4.Serial measurement of R2I2 will produce consistent values.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 6, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 10, 2014

Completed
8.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

November 9, 2020

Status Verified

November 1, 2020

Enrollment Period

9.1 years

First QC Date

February 6, 2014

Last Update Submit

November 6, 2020

Conditions

Ischemic CardiomyopathySudden Cardiac DeathImplantable Defibrillator UserMyocardial InfarctionArrhythmias, Cardiac

Keywords

Action potential duration restitutionVentricular arrhythmiaSudden cardiac deathBody-surface potential mappingElectrocardiogram

Outcome Measures

Primary Outcomes (1)

  • Ventricular arrhythmia/Sudden cardiac death

    18 months

Secondary Outcomes (2)

  • Syncope

    18 months

  • All cause mortality

    18 months

Study Arms (1)

Ischaemic cardiomyopathy

Patients with ischaemic cardiomyopathy attending for ICD implantation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with ischaemic cardiomyopathy attending for ICD implantation

You may qualify if:

  • Age \>18
  • History of ischaemic cardiomyopathy

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NIHR Leicester Cardiovascular Biomedical Research Unit

Leicester, LE3 9QP, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Fresh Frozen Plasma

MeSH Terms

Conditions

Death, Sudden, CardiacMyocardial InfarctionArrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart ArrestHeart DiseasesCardiovascular DiseasesDeath, SuddenDeathPathologic ProcessesPathological Conditions, Signs and SymptomsMyocardial IschemiaVascular DiseasesInfarctionIschemiaNecrosis

Study Officials

  • G. Andre Ng, MBChB, PhD

    University of Leicester

    PRINCIPAL INVESTIGATOR

Central Study Contacts

M. Shoaib Siddiqui, MBBS

CONTACT

+44 116 258 3643mss33@le.ac.uk

Will B Nicolson, MBChB

CONTACT

wbn1@le.ac.uk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2014

First Posted

February 10, 2014

Study Start

October 1, 2013

Primary Completion

November 1, 2022

Study Completion

November 1, 2022

Last Updated

November 9, 2020

Record last verified: 2020-11

Locations

GB(1)