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

• Sponsor: Maastricht University Medical Center (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04074122
• Collaborator: University of Freiburg (Other), University of Bern (Other)
• Enrollment: 150
• Anticipated Duration (Months): 24

Study Details

Study Description

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	Phase
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.

Study Design

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

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. Differences in regional electromechanical dispersion between LQTS patients and controls [At day of investigation]

   Electromechanical dispersion in milliseconds

2. Differences in regional electromechanical dispersion between symptomatic and asymptomatic LQTS patients [At day of investigation]

   Electromechanical dispersion in milliseconds

Secondary Outcome Measures

1. Correlation of electromechanical dispersion between LQTS type 1, 2, and 3. [At day of investigation]

   Electromechanical dispersion in milliseconds

2. Relation between global electromechanical window vs regional electromechanical dispersion in LQTS [At day of investigation]

   Electromechanical dispersion in milliseconds

3. Correlation between mechanical dispersion using TPM-MRI and cine-MRI [At day of investigation]

   Time-to-diastolic peak in milliseconds

4. Correlation between mechanical dispersion using TPM-MRI and speckle-tracking echocardiography [At day of investigation]

   Time-to-peak in milliseconds

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Maastricht University Medical Center
• University of Freiburg
• University of Bern

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Maastricht University Medical Center
• ClinicalTrials.gov Identifier: NCT04074122
• Other Study ID Numbers: 70856
• First Posted: Aug 29, 2019
• Last Update Posted: Aug 29, 2019
• Last Verified: Aug 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• 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: Tachycardia; Tachycardia, Ventricular; Death, Sudden, Cardiac; Long QT Syndrome; Syndrome; Death; Adenosine; Isoproterenol; Epinephrine

Study Results

No Results Posted as of Aug 29, 2019