Premature Ventricular ComplexNCT05078125
Electrocardiographic and Cardiac Magnetic Resonance Predictors of Ventricular Arrhythmias in Cardiomyopathic Patients
An observational study of Premature Ventricular Complex, run by Assiut University.
Trial summary
This study aims to assess ECG changes for predicting ventricular arrhythmia in cardiomyopathic patients Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Premature Ventricular Complex
- What is being tested?
- Holter monitoring
- Type of treatment
- Medical device
- How many people
- 79 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2022to 30 Mar 2023
- 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 20 to 70 years
- All sexes
- Adult, Older adult
Study population: The study is anticipated to include all consecutive eligible cardiomyopathic patients.
Who may be able to join
- Patients with ischemic and non-ischemic cardiomyopathy, EF < 40 %
- Patient haemodynamically stable
- Patients accept to make test
Who cannot join
- Patients with underlying arrhythmia ex heart block or atrial arrhythmia like PACs, AF.
- Patients on arrhythmogenic drugs ex digitalis, amiodarone.
- Patients on underlying Pacemaker device or CRT-D.
- Patients with MI in less than 40 days
- Patients refuse to make test .
About this study
Official title: ECG and CMR for Predicting PVCs in Cardiomyopathic Patients
This study aims to assess ECG changes for predicting ventricular arrhythmia in cardiomyopathic patients
Read the detailed description
This study aims to assess ECG markers based on 24-hour Holter ECG recordings for predicting ventricular arrhythmia in patients with Structural Heart disease who have left ventricular dysfunction and Left Ventricular Ejection Fraction ≤40%. With special concerns to underlying structural abnormalities in cardiomyopathic patients using Cardiac Magnetic Resonance to determine ventricular function, scar distribution, and grey zone analysis
- Conditions
- Premature Ventricular Complex
- Being tested
- Holter monitoring
- Medical subject headings
- Ventricular Premature Complexes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Holter monitoringDevice
24 hours Holter monitoring
What is being measured
The primary outcome is the main question the study is designed to answer.
Twenty-four hours Holter monitoring after Magnetic Resonance Imaging
24 Holter monitoring to detect PVCs burden which is defined as ≥10% of total beats
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2021
- Study start1 Apr 2022 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion30 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Premature Ventricular ComplexStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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 only
- Time perspective
- Prospective
- Enrolment
- 79 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khaled Mohamed Aly, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05078125
- Sponsor's protocol ID
- AssiutU KMAly
- Status last verified
- Jan 2022
- First submitted
- 2 Oct 2021
- Last updated
- 25 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Mathew T, Williams L, Navaratnam G, Rana B, Wheeler R, Collins K, Harkness A, Jones R, Knight D, O'Gallagher K, Oxborough D, Ring L, Sandoval J, Stout M, Sharma V, Steeds RP; British Society of Echocardiography Education Committee. Diagnosis and assessment of dilated cardiomyopathy: a guideline protocol from the British Society of Echocardiography. Echo Res Pract. 2017 Jun;4(2):G1-G13. doi: 10.1530/ERP-16-0037.
PubMed 28592613Pinto YM, Elliott PM, Arbustini E, Adler Y, Anastasakis A, Bohm M, Duboc D, Gimeno J, de Groote P, Imazio M, Heymans S, Klingel K, Komajda M, Limongelli G, Linhart A, Mogensen J, Moon J, Pieper PG, Seferovic PM, Schueler S, Zamorano JL, Caforio AL, Charron P. Proposal for a revised definition of dilated cardiomyopathy, hypokinetic non-dilated cardiomyopathy, and its implications for clinical practice: a position statement of the ESC working group on myocardial and pericardial diseases. Eur Heart J. 2016 Jun 14;37(23):1850-8. doi: 10.1093/eurheartj/ehv727. Epub 2016 Jan 19.
PubMed 26792875Sharma E, Arunachalam K, Di M, Chu A, Maan A. PVCs, PVC-Induced Cardiomyopathy, and the Role of Catheter Ablation. Crit Pathw Cardiol. 2017 Jun;16(2):76-80. doi: 10.1097/HPC.0000000000000106.
PubMed 28509708Lee DC, Markl M, Dall'Armellina E, Han Y, Kozerke S, Kuehne T, Nielles-Vallespin S, Messroghli D, Patel A, Schaeffter T, Simonetti O, Valente AM, Weinsaft JW, Wright G, Zimmerman S, Schulz-Menger J. The growth and evolution of cardiovascular magnetic resonance: a 20-year history of the Society for Cardiovascular Magnetic Resonance (SCMR) annual scientific sessions. J Cardiovasc Magn Reson. 2018 Jan 31;20(1):8. doi: 10.1186/s12968-018-0429-z.
PubMed 29386064
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ECG and CMR for Predicting PVCs in Cardiomyopathic Patients
- ClinicalTrials.gov ID
- NCT05078125
- Acronym / sponsor ID
- AssiutU KMAly
- Conditions
- Premature Ventricular Complex
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 79 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 30 Mar 2023 (estimated)
- First posted
- 14 Oct 2021 (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.
This study aims to assess ECG changes for predicting ventricular arrhythmia in cardiomyopathic patients
Detailed description
This study aims to assess ECG markers based on 24-hour Holter ECG recordings for predicting ventricular arrhythmia in patients with Structural Heart disease who have left ventricular dysfunction and Left Ventricular Ejection Fraction ≤40%. With special concerns to underlying structural abnormalities in cardiomyopathic patients using Cardiac Magnetic Resonance to determine ventricular function, scar distribution, and grey zone analysis
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study is anticipated to include all consecutive eligible cardiomyopathic patients.
Key inclusion criteria (3 listed)
- Patients with ischemic and non-ischemic cardiomyopathy, EF < 40 %
- Patient haemodynamically stable
- Patients accept to make test
Key exclusion criteria (5 listed)
- Patients with underlying arrhythmia ex heart block or atrial arrhythmia like PACs, AF.
- Patients on arrhythmogenic drugs ex digitalis, amiodarone.
- Patients on underlying Pacemaker device or CRT-D.
- Patients with MI in less than 40 days
- Patients refuse to make test .
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 |
|---|---|---|
| Holter monitoring24 hours Holter monitoring | Device | – |
Primary outcome
Twenty-four hours Holter monitoring after Magnetic Resonance Imaging
Time frame: One year
24 Holter monitoring to detect PVCs burden which is defined as ≥10% of total beats
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2022.
- Results publication: PubMed 28592613Mathew T, Williams L, Navaratnam G, Rana B, Wheeler R, Collins K, Harkness A, Jones R, Knight D, O'Gallagher K, Oxborough D, Ring L, Sandoval J, Stout M, Sharma V, Steeds RP; British Society of Echocardiography Education Committee. Diagnosis and assessment of dilated cardiomyopathy: a guideline protocol from the British Society of Echocardiography. Echo Res Pract. 2017 Jun;4(2):G1-G13. doi: 10.1530/ERP-16-0037.
- Results publication: PubMed 26792875Pinto YM, Elliott PM, Arbustini E, Adler Y, Anastasakis A, Bohm M, Duboc D, Gimeno J, de Groote P, Imazio M, Heymans S, Klingel K, Komajda M, Limongelli G, Linhart A, Mogensen J, Moon J, Pieper PG, Seferovic PM, Schueler S, Zamorano JL, Caforio AL, Charron P. Proposal for a revised definition of dilated cardiomyopathy, hypokinetic non-dilated cardiomyopathy, and its implications for clinical practice: a position statement of the ESC working group on myocardial and pericardial diseases. Eur Heart J. 2016 Jun 14;37(23):1850-8. doi: 10.1093/eurheartj/ehv727. Epub 2016 Jan 19.
- Results publication: PubMed 28509708Sharma E, Arunachalam K, Di M, Chu A, Maan A. PVCs, PVC-Induced Cardiomyopathy, and the Role of Catheter Ablation. Crit Pathw Cardiol. 2017 Jun;16(2):76-80. doi: 10.1097/HPC.0000000000000106.
- Results publication: PubMed 29386064Lee DC, Markl M, Dall'Armellina E, Han Y, Kozerke S, Kuehne T, Nielles-Vallespin S, Messroghli D, Patel A, Schaeffter T, Simonetti O, Valente AM, Weinsaft JW, Wright G, Zimmerman S, Schulz-Menger J. The growth and evolution of cardiovascular magnetic resonance: a 20-year history of the Society for Cardiovascular Magnetic Resonance (SCMR) annual scientific sessions. J Cardiovasc Magn Reson. 2018 Jan 31;20(1):8. doi: 10.1186/s12968-018-0429-z.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Premature Ventricular Complex, run by Assiut University.
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 3 inclusion and 5 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 25 Jan 2022. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Twenty-four hours Holter monitoring after Magnetic Resonance Imaging (time frame: One year). 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 NCT05078125, which also lists 4 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 25 Jan 2022.