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

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ClinicalTrials.gov Identifier: NCT04074122
Recruitment Status : Not yet recruiting
First Posted : August 29, 2019
Last Update Posted : August 29, 2019
Sponsor:
Collaborators:
University of Freiburg
University of Bern
Information provided by (Responsible Party):
Maastricht University Medical Center

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

Condition or disease Intervention/treatment
Long QT Syndrome Sudden Cardiac Death Ventricular Tachycardia Diagnostic Test: Adenosine and epinephrine, isoprenaline provocation

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.

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Electromechanical Profiling of Arrhythmogenic Substrates and Triggers in the Long-QT Syndrome
Estimated Study Start Date : January 1, 2020
Estimated Primary Completion Date : January 1, 2022
Estimated Study Completion Date : January 1, 2022


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.




Primary Outcome Measures :
  1. Differences in regional electromechanical dispersion between LQTS patients and controls [ Time Frame: At day of investigation ]
    Electromechanical dispersion in milliseconds

  2. Differences in regional electromechanical dispersion between symptomatic and asymptomatic LQTS patients [ Time Frame: At day of investigation ]
    Electromechanical dispersion in milliseconds


Secondary Outcome Measures :
  1. Correlation of electromechanical dispersion between LQTS type 1, 2, and 3. [ Time Frame: At day of investigation ]
    Electromechanical dispersion in milliseconds

  2. Relation between global electromechanical window vs regional electromechanical dispersion in LQTS [ Time Frame: At day of investigation ]
    Electromechanical dispersion in milliseconds

  3. Correlation between mechanical dispersion using TPM-MRI and cine-MRI [ Time Frame: At day of investigation ]
    Time-to-diastolic peak in milliseconds

  4. Correlation between mechanical dispersion using TPM-MRI and speckle-tracking echocardiography [ Time Frame: At day of investigation ]
    Time-to-peak in milliseconds



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Based on self-representation.
Accepts Healthy Volunteers:   Yes
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.
Criteria

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.

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): NCT04074122


Contacts
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Contact: Rachel ter Bekke, MD, PhD +31433877095 rachel.ter.bekke@mumc.nl
Contact: Paul Volders, MD, PhD +31433877093 p.volders@maastrichtuniversity.nl

Sponsors and Collaborators
Maastricht University Medical Center
University of Freiburg
University of Bern
Investigators
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Principal Investigator: Paul Volders, MD, PhD Maastricht UMC+

Publications of Results:

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Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT04074122     History of Changes
Other Study ID Numbers: 70856
First Posted: August 29, 2019    Key Record Dates
Last Update Posted: August 29, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Maastricht University Medical Center:
Electromechanical Mapping
Risk Stratification
Additional relevant MeSH terms:
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Tachycardia
Tachycardia, Ventricular
Death, Sudden, Cardiac
Long QT Syndrome
Syndrome
Death
Disease
Pathologic Processes
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Heart Arrest
Death, Sudden
Heart Defects, Congenital
Cardiovascular Abnormalities
Congenital Abnormalities
Adenosine
Isoproterenol
Epinephrine
Racepinephrine
Epinephryl borate
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents