Electromechanical Profiling of the Long-QT Syndrome (LQTS)

Ventricular Tachycardia Clinical Trial

— EMLoQ  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04074122
• Other study ID #: 70856
• Status: Not yet recruiting
• Start date: January 1, 2020
• Est. completion date: January 1, 2022

Study information

• Verified date: August 2019
• Source: Maastricht University Medical Center
• Contact: Rachel ter Bekke, MD, PhD
• Phone: +31433877095
• Email: rachel.ter.bekke[@]mumc.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: January 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Death
• Death, Sudden, Cardiac
• Long QT Syndrome
• Sudden Cardiac Death
• Syndrome
• Tachycardia
• Tachycardia, Ventricular
• Ventricular Tachycardia

Intervention

Diagnostic Test:
• Adenosine and epinephrine, isoprenaline provocation
High-resolution electromechanical mapping at baseline and after provocative measures.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Maastricht University Medical Center	University of Bern, University of Freiburg

References & Publications (6)

Haugaa KH, Amlie JP, Berge KE, Leren TP, Smiseth OA, Edvardsen T. Transmural differences in myocardial contraction in long-QT syndrome: mechanical consequences of ion channel dysfunction. Circulation. 2010 Oct 5;122(14):1355-63. doi: 10.1161/CIRCULATIONAH — View Citation

Haugaa KH, Edvardsen T, Leren TP, Gran JM, Smiseth OA, Amlie JP. Left ventricular mechanical dispersion by tissue Doppler imaging: a novel approach for identifying high-risk individuals with long QT syndrome. Eur Heart J. 2009 Feb;30(3):330-7. doi: 10.109 — View Citation

Shimizu W, Antzelevitch C. Differential effects of beta-adrenergic agonists and antagonists in LQT1, LQT2 and LQT3 models of the long QT syndrome. J Am Coll Cardiol. 2000 Mar 1;35(3):778-86. — View Citation

ter Bekke RM, Haugaa KH, van den Wijngaard A, Bos JM, Ackerman MJ, Edvardsen T, Volders PG. Electromechanical window negativity in genotyped long-QT syndrome patients: relation to arrhythmia risk. Eur Heart J. 2015 Jan 14;36(3):179-86. doi: 10.1093/eurhea — View Citation

ter Bekke RM, Volders PG. Arrhythmogenic mechano-electric heterogeneity in the long-QT syndrome. Prog Biophys Mol Biol. 2012 Oct-Nov;110(2-3):347-58. doi: 10.1016/j.pbiomolbio.2012.07.007. Epub 2012 Jul 24. Review. — View Citation

Viskin S, Rosso R, Rogowski O, Belhassen B, Levitas A, Wagshal A, Katz A, Fourey D, Zeltser D, Oliva A, Pollevick GD, Antzelevitch C, Rozovski U. Provocation of sudden heart rate oscillation with adenosine exposes abnormal QT responses in patients with lo — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences in regional electromechanical dispersion between LQTS patients and controls	Electromechanical dispersion in milliseconds	At day of investigation
Primary	Differences in regional electromechanical dispersion between symptomatic and asymptomatic LQTS patients	Electromechanical dispersion in milliseconds	At day of investigation
Secondary	Correlation of electromechanical dispersion between LQTS type 1, 2, and 3.	Electromechanical dispersion in milliseconds	At day of investigation
Secondary	Relation between global electromechanical window vs regional electromechanical dispersion in LQTS	Electromechanical dispersion in milliseconds	At day of investigation
Secondary	Correlation between mechanical dispersion using TPM-MRI and cine-MRI	Time-to-diastolic peak in milliseconds	At day of investigation
Secondary	Correlation between mechanical dispersion using TPM-MRI and speckle-tracking echocardiography	Time-to-peak in milliseconds	At day of investigation