Left Ventricle Non-compaction CardiomyopathyNCT05281315
Cardiac Magnetic Resonance Features and Outcomes of Patients With Non-Compaction Cardiomyopathy - a Retrospective Follow-up From Pakistan
An observational study of Left Ventricle Non-compaction Cardiomyopathy, run by Aga Khan University Hospital, Pakistan.
Trial summary
Objective: To evaluate clinical characteristics, cardiac magnetic resonance imaging features, and outcomes of patients with left ventricle non-compaction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Left Ventricle Non-compaction Cardiomyopathy
- How many people
- 294 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2011to 31 Dec 2020
- 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
- No healthy volunteers
- Adult, Older adult
Study population: We retrospectively enrolled 294 patients referred for CMR from 2011 to 2020 for evaluation of cardiomyopathy. Of these, 51% were ischemic cardiomyopathy, 26% were dilated cardiomyopathy, 25% were hypertrophic cardiomyopathy, 13% were restrictive cardiomyopathy, and 6% were arrhythmogenic right ventricle dysplasia. For final enrolment, patients with intracardiac masses, pericardial diseases and congenital heart diseases were excluded from the study. Patients with evidence of LV non-compaction were further analysed for baseline characteristics, CMR parameters and outcomes. Characteristics of this group were compared with 47 patients who had dilated cardiomyopathy without evidence of LV non-compaction.
Who may be able to join
- Patients > 18 years, referred for CMR for further evaluation of cardiomyopathy.
Who cannot join
- patients with intracardiac masses, pericardial diseases and congenital heart diseases were excluded from the study.
About this study
Objective: To evaluate clinical characteristics, cardiac magnetic resonance imaging features, and outcomes of patients with left ventricle non-compaction.
Read the detailed description
Left Ventricle Non-Compaction Cardiomyopathy (LVNCC) is a type of myocardial disease characterized by prominent myocardial trabeculae and recesses resulting in two distinct layers of myocardium: compacted layer and the non-compacted layer. It arises due to the failure of left ventricle (LV) maturation and compaction during intra-uterine life (1). As per the position statement from the European Society of Cardiology, LVNCC has been labelled as 'unclassified' type of cardiomyopathy. Clinical course can be complicated by heart failure, thromboembolism, or arrhythmia.
Phenotypic presentation of LVNC can range from extremely thickened layer of non-compacted myocardium to mere presence of prominent trabeculae and recesses albeit a compacted myocardium. Transthoracic echocardiography is the first tool to diagnose LVNC. However, Cardiac Magnetic Resonance (CMR) imaging has emerged as a strong tool to differentiate between LVNCC from mere hyper-trabeculated LV myocardium when echocardiogram is inconclusive (Figure 1 and Video 1). Various criteria have evolved to diagnose LVNC by CMR. Peterson et al defined the end-diastole non-compacted to compacted myocardium ratio of >2.3 to have good sensitivity, specificity, and negative predictive value for differentiating pathological non-compaction from hyper-trabeculation.
With an increase in the use of diagnostic cardiovascular imaging modalities in South-Asian (SA) belt, LVNC is being increasingly diagnosed. The exact prevalence of LVNC in SA is not known and phenotypic CMR characteristics, clinical features, and outcomes of LVNC remain unknown for SA population. This brought us to the need of analysing CMR data of LVNC at our centre.
- Being tested
- Patients were retrospectively enrolled. This was a retrospective study and no intervention was performed.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients were retrospectively enrolled. This was a retrospective study and no intervention was performed.Other
Patients were retrospectively enrolled. This was a retrospective study and no intervention was performed.
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate clinical characteristics, cardiac magnetic resonance imaging features, and outcomes of patients with left ventricle non-compaction.
Evaluating CMR features and looking at outcomes such as all cause mortality, major heart failure or arrhythmia hospitalizations.
Measured: 37 months
Secondary outcomes (1)
All cause-mortality, heart failure hospitalization, and arrhythmia hospitalization.
All cause-mortality, heart failure hospitalization, and arrhythmia hospitalization.
Measured: 37 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2022
- Study start1 Jan 2011
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Left Ventricle Non-compaction CardiomyopathyStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 294 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University Hospital, Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pirbhat Shams, Aga Khan University Hospital, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05281315
- Sponsor's protocol ID
- 2020-5594-14863
- Status last verified
- Mar 2022
- First submitted
- 7 Mar 2022
- Last updated
- 16 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Magnetic Resonance Features and Outcomes of Patients With Non-Compaction Cardiomyopathy - a Retrospective Follow-up From Pakistan
- ClinicalTrials.gov ID
- NCT05281315
- Acronym / sponsor ID
- 2020-5594-14863
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 294 participants (actual)
- Lead sponsor
- Aga Khan University Hospital, PakistanUniversity, hospital or other
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 16 Mar 2022 (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.
Objective: To evaluate clinical characteristics, cardiac magnetic resonance imaging features, and outcomes of patients with left ventricle non-compaction.
Detailed description
Left Ventricle Non-Compaction Cardiomyopathy (LVNCC) is a type of myocardial disease characterized by prominent myocardial trabeculae and recesses resulting in two distinct layers of myocardium: compacted layer and the non-compacted layer. It arises due to the failure of left ventricle (LV) maturation and compaction during intra-uterine life (1). As per the position statement from the European Society of Cardiology, LVNCC has been labelled as 'unclassified' type of cardiomyopathy. Clinical course can be complicated by heart failure, thromboembolism, or arrhythmia.
Phenotypic presentation of LVNC can range from extremely thickened layer of non-compacted myocardium to mere presence of prominent trabeculae and recesses albeit a compacted myocardium. Transthoracic echocardiography is the first tool to diagnose LVNC. However, Cardiac Magnetic Resonance (CMR) imaging has emerged as a strong tool to differentiate between LVNCC from mere hyper-trabeculated LV myocardium when echocardiogram is inconclusive (Figure 1 and Video 1). Various criteria have evolved to diagnose LVNC by CMR. Peterson et al defined the end-diastole non-compacted to compacted myocardium ratio of >2.3 to have good sensitivity, specificity, and negative predictive value for differentiating pathological non-compaction from hyper-trabeculation.
With an increase in the use of diagnostic cardiovascular imaging modalities in South-Asian (SA) belt, LVNC is being increasingly diagnosed. The exact prevalence of LVNC in SA is not known and phenotypic CMR characteristics, clinical features, and outcomes of LVNC remain unknown for SA population. This brought us to the need of analysing CMR data of LVNC at our centre.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We retrospectively enrolled 294 patients referred for CMR from 2011 to 2020 for evaluation of cardiomyopathy. Of these, 51% were ischemic cardiomyopathy, 26% were dilated cardiomyopathy, 25% were hypertrophic cardiomyopathy, 13% were restrictive cardiomyopathy, and 6% were arrhythmogenic right ventricle dysplasia. For final enrolment, patients with intracardiac masses, pericardial diseases and congenital heart diseases were excluded from the study. Patients with evidence of LV non-compaction were further analysed for baseline characteristics, CMR parameters and outcomes. Characteristics of this group were compared with 47 patients who had dilated cardiomyopathy without evidence of LV non-compaction.
Key inclusion criteria (1 listed)
- Patients > 18 years, referred for CMR for further evaluation of cardiomyopathy.
Key exclusion criteria (1 listed)
- patients with intracardiac masses, pericardial diseases and congenital heart diseases were excluded from the study.
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 |
|---|---|---|
| Patients were retrospectively enrolled. This was a retrospective study and no intervention was performed.Patients were retrospectively enrolled. This was a retrospective study and no intervention was performed. | Other | – |
Primary outcome
To evaluate clinical characteristics, cardiac magnetic resonance imaging features, and outcomes of patients with left ventricle non-compaction.
Time frame: 37 months
Evaluating CMR features and looking at outcomes such as all cause mortality, major heart failure or arrhythmia hospitalizations.
1 secondary outcome
All cause-mortality, heart failure hospitalization, and arrhythmia hospitalization.
Time frame: 37 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2022.
- Individual participant dataSharing planned: No
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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 Left Ventricle Non-compaction Cardiomyopathy, run by Aga Khan University Hospital, Pakistan.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 16 Mar 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To evaluate clinical characteristics, cardiac magnetic resonance imaging features, and outcomes of patients with left ventricle non-compaction. (time frame: 37 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Mar 2022.