Electromechanical Profiling of the Long-QT Syndrome (LQTS) (EMLoQ)

August 28, 2019 updated by: Maastricht University Medical Center

Electromechanical Profiling of Arrhythmogenic Substrates and Triggers in the Long-QT Syndrome

High-resolution, non-invasive electromechanical mapping in genotyped long-QT syndrome patients and healthy controls at baseline and during smart provocation.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Using simultaneous ECG-imaging, speckle-tracking analysis and tissue-phase mapping with MRI we will assess electromechanical dispersion at rest. Regional electromechanical elasticity will be investigated during adenosine and epinephrine, isoprenaline infusions and is postulated to increase sudden cardiac death risk prediction in the individual patient.

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Potential study subjects will be selected from the Cardiogenetic or Cardiac Outpatient Clinic or during their in-hospital stay.

Description

Inclusion Criteria:

LQTS group (Group 1):

  • Diagnosis of LQTS according to the ESC guidelines.
  • Genetic testing either already performed or consent to genetic testing (at least 5 major LQTS-related genes tested: KCNQ1, KCNH2, SCN5A, KCNE1, KCNE2).

Control group (Group 2):

> Control subjects with structurally normal hearts.

Exclusion Criteria:

  • Pregnancy, nursing or planning to become pregnant.
  • Known allergy or strong reaction to skin electrodes or contrast agent.
  • Inability to give informed consent.
  • Presence of metal objects in or attached to the body.
  • Dialysis.
  • Cardiomyopathy.
  • Second-degree heart block or higher degrees of block.
  • Sick sinus syndrome.
  • Asthma.
  • Chronic obstructive pulmonary disease.
  • Left-main coronary artery disease.
  • Unstable coronary artery disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Symptomatic LQTS patients
Pharmacological (adenosine, epinephrine, isoprenaline) provocation, ECG-imaging and tissue-phase mapping using magnetic resonance imaging (TPM-MRI).
Diagnostic test: Adenosine and epinephrine, isoprenaline provocation
High-resolution electromechanical mapping at baseline and after provocative measures.
Other Names:
  • ECG-imaging
  • Tissue-phase mapping with MRI.
Asymptomatic LQTS patients
Pharmacological (adenosine, epinephrine, isoprenaline) provocation, ECG-imaging and tissue-phase mapping using magnetic resonance imaging (TPM-MRI).
Diagnostic test: Adenosine and epinephrine, isoprenaline provocation
High-resolution electromechanical mapping at baseline and after provocative measures.
Other Names:
  • ECG-imaging
  • Tissue-phase mapping with MRI.
Healthy controls
Pharmacological (adenosine, epinephrine, isoprenaline) provocation, ECG-imaging and tissue-phase mapping using magnetic resonance imaging (TPM-MRI).
Diagnostic test: Adenosine and epinephrine, isoprenaline provocation
High-resolution electromechanical mapping at baseline and after provocative measures.
Other Names:
  • ECG-imaging
  • Tissue-phase mapping with MRI.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences in regional electromechanical dispersion between LQTS patients and controls
Time Frame: At day of investigation
Electromechanical dispersion in milliseconds
At day of investigation
Differences in regional electromechanical dispersion between symptomatic and asymptomatic LQTS patients
Time Frame: At day of investigation
Electromechanical dispersion in milliseconds
At day of investigation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of electromechanical dispersion between LQTS type 1, 2, and 3.
Time Frame: At day of investigation
Electromechanical dispersion in milliseconds
At day of investigation
Relation between global electromechanical window vs regional electromechanical dispersion in LQTS
Time Frame: At day of investigation
Electromechanical dispersion in milliseconds
At day of investigation
Correlation between mechanical dispersion using TPM-MRI and cine-MRI
Time Frame: At day of investigation
Time-to-diastolic peak in milliseconds
At day of investigation
Correlation between mechanical dispersion using TPM-MRI and speckle-tracking echocardiography
Time Frame: At day of investigation
Time-to-peak in milliseconds
At day of investigation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Collaborators

University of Bern
University of Freiburg

Investigators

  • Principal Investigator: Paul Volders, MD, PhD, Maastricht UMC+

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2020

Primary Completion (Anticipated)

January 1, 2022

Study Completion (Anticipated)

January 1, 2022

Study Registration Dates

First Submitted

July 5, 2019

First Submitted That Met QC Criteria

August 28, 2019

First Posted (Actual)

August 29, 2019

Study Record Updates

Last Update Posted (Actual)

August 29, 2019

Last Update Submitted That Met QC Criteria

August 28, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 70856

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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