Long QT SyndromeEMLoQNCT04074122
Electromechanical Profiling of the Long-QT Syndrome (LQTS)
An observational study of Long QT Syndrome and Sudden Cardiac Death, run by Maastricht University Medical Center.
Trial summary
High-resolution, non-invasive electromechanical mapping in genotyped long-QT syndrome patients and healthy controls at baseline and during smart provocation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Long QT Syndrome, Sudden Cardiac Death, Ventricular Tachycardia
- What is being tested?
- Adenosine and epinephrine, isoprenaline provocation
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2020to 1 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Potential study subjects will be selected from the Cardiogenetic or Cardiac Outpatient Clinic or during their in-hospital stay.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Being tested
- Adenosine and epinephrine, isoprenaline provocation
- Keywords
- Electromechanical Mapping, Risk Stratification
- Medical subject headings
- Long QT Syndrome, Death, Sudden, Cardiac, Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adenosine and epinephrine, isoprenaline provocationDiagnostic test
Also called ECG-imaging, Tissue-phase mapping with MRI.
High-resolution electromechanical mapping at baseline and after provocative measures.
| Study group | Role | What they receive |
|---|---|---|
| Symptomatic LQTS patients | Pharmacological (adenosine, epinephrine, isoprenaline) provocation, ECG-imaging and tissue-phase mapping using magnetic resonance imaging (TPM-MRI). Receives: Diagnostic Test: Adenosine and epinephrine, isoprenaline provocation | |
| Asymptomatic LQTS patients | Pharmacological (adenosine, epinephrine, isoprenaline) provocation, ECG-imaging and tissue-phase mapping using magnetic resonance imaging (TPM-MRI). Receives: Diagnostic Test: Adenosine and epinephrine, isoprenaline provocation | |
| Healthy controls | Pharmacological (adenosine, epinephrine, isoprenaline) provocation, ECG-imaging and tissue-phase mapping using magnetic resonance imaging (TPM-MRI). Receives: Diagnostic Test: Adenosine and epinephrine, isoprenaline provocation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in regional electromechanical dispersion between LQTS patients and controls
Electromechanical dispersion in milliseconds
Measured: At day of investigation
Differences in regional electromechanical dispersion between symptomatic and asymptomatic LQTS patients
Electromechanical dispersion in milliseconds
Measured: At day of investigation
Secondary outcomes (4)
Correlation of electromechanical dispersion between LQTS type 1, 2, and 3.
Electromechanical dispersion in milliseconds
Measured: At day of investigation
Relation between global electromechanical window vs regional electromechanical dispersion in LQTS
Electromechanical dispersion in milliseconds
Measured: At day of investigation
Correlation between mechanical dispersion using TPM-MRI and cine-MRI
Time-to-diastolic peak in milliseconds
Measured: At day of investigation
Correlation between mechanical dispersion using TPM-MRI and speckle-tracking echocardiography
Time-to-peak in milliseconds
Measured: At day of investigation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2019
- Study start1 Jan 2020 (estimated)
- Primary completion1 Jan 2022 (estimated)
- Study completion1 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Long QT SyndromeStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Freiburg, University of Bern
- Responsible party
- Sponsor
- Investigators
- Paul Volders, MD, PhD, Principal investigator, Maastricht UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04074122
- Sponsor's protocol ID
- 70856
- Acronym
- EMLoQ
- Status last verified
- Aug 2019
- First submitted
- 5 Jul 2019
- Last updated
- 29 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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: 10.1093/eurheartj/ehn466. Epub 2008 Oct 21.
PubMed 18940888Haugaa 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/CIRCULATIONAHA.110.960377. Epub 2010 Sep 20.
PubMed 20855658ter 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.
PubMed 22841828ter 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/eurheartj/ehu370. Epub 2014 Sep 8.
PubMed 25205533Shimizu 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. doi: 10.1016/s0735-1097(99)00582-3.
PubMed 10716483Viskin 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 long QT syndrome: a bedside test for diagnosing long QT syndrome. Eur Heart J. 2006 Feb;27(4):469-75. doi: 10.1093/eurheartj/ehi460. Epub 2005 Aug 16.
PubMed 16105845
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electromechanical Profiling of Arrhythmogenic Substrates and Triggers in the Long-QT Syndrome
- ClinicalTrials.gov ID
- NCT04074122
- Acronym / sponsor ID
- EMLoQ / 70856
- Keywords
- Electromechanical Mapping, Risk Stratification
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- University of Freiburg, University of Bern
- Study start
- 1 Jan 2020 (estimated)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 1 Jan 2022 (estimated)
- First posted
- 29 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
High-resolution, non-invasive electromechanical mapping in genotyped long-QT syndrome patients and healthy controls at baseline and during smart 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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Symptomatic LQTS patients | – | Diagnostic Test: Adenosine and epinephrine, isoprenaline provocationPharmacological (adenosine, epinephrine, isoprenaline) provocation, ECG-imaging and tissue-phase mapping using magnetic resonance imaging (TPM-MRI). |
| Asymptomatic LQTS patients | – | Diagnostic Test: Adenosine and epinephrine, isoprenaline provocationPharmacological (adenosine, epinephrine, isoprenaline) provocation, ECG-imaging and tissue-phase mapping using magnetic resonance imaging (TPM-MRI). |
| Healthy controls | – | Diagnostic Test: Adenosine and epinephrine, isoprenaline provocationPharmacological (adenosine, epinephrine, isoprenaline) provocation, ECG-imaging and tissue-phase mapping using magnetic resonance imaging (TPM-MRI). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Potential study subjects will be selected from the Cardiogenetic or Cardiac Outpatient Clinic or during their in-hospital stay.
Key inclusion criteria (5 listed)
- 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 subjects with structurally normal hearts.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adenosine and epinephrine, isoprenaline provocationAlso: ECG-imaging, Tissue-phase mapping with MRI.High-resolution electromechanical mapping at baseline and after provocative measures. | Diagnostic test | Asymptomatic LQTS patients, Healthy controls, Symptomatic LQTS patients |
Primary outcome
Differences in regional electromechanical dispersion between LQTS patients and controls
Time frame: At day of investigation
Electromechanical dispersion in milliseconds
Differences in regional electromechanical dispersion between symptomatic and asymptomatic LQTS patients
Time frame: At day of investigation
Electromechanical dispersion in milliseconds
4 secondary outcomes
Correlation of electromechanical dispersion between LQTS type 1, 2, and 3.
Time frame: At day of investigation
Relation between global electromechanical window vs regional electromechanical dispersion in LQTS
Time frame: At day of investigation
Correlation between mechanical dispersion using TPM-MRI and cine-MRI
Time frame: At day of investigation
Correlation between mechanical dispersion using TPM-MRI and speckle-tracking echocardiography
Time frame: At day of investigation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2019.
- Results publication: PubMed 18940888Haugaa 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: 10.1093/eurheartj/ehn466. Epub 2008 Oct 21.
- Results publication: PubMed 20855658Haugaa 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/CIRCULATIONAHA.110.960377. Epub 2010 Sep 20.
- Results publication: PubMed 22841828ter 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.
- Results publication: PubMed 25205533ter 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/eurheartj/ehu370. Epub 2014 Sep 8.
- Results publication: PubMed 10716483Shimizu 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. doi: 10.1016/s0735-1097(99)00582-3.
- Results publication: PubMed 16105845Viskin 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 long QT syndrome: a bedside test for diagnosing long QT syndrome. Eur Heart J. 2006 Feb;27(4):469-75. doi: 10.1093/eurheartj/ehi460. Epub 2005 Aug 16.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Volders, MD, PhD principal investigator
Maastricht UMC
Questions about this trial
What is this clinical trial studying?
An observational study of Long QT Syndrome and Sudden Cardiac Death, run by Maastricht University Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rachel ter Bekke, MD, PhD (+31433877095, rachel.ter.bekke@mumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in regional electromechanical dispersion between LQTS patients and controls (time frame: At day of investigation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04074122, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2019.