Patients were retrospectively enrolled. This was a retrospective study and no intervention was performed.
OtherPatients were retrospectively enrolled. This was a retrospective study and no intervention was performed.
Completed
NCT Number: NCT05281315
Cardiac Magnetic Resonance Features and Outcomes of Patients With Non-Compaction Cardiomyopathy - a Retrospective Follow-up From Pakistan
Objective: To evaluate clinical characteristics, cardiac magnetic resonance imaging features, and outcomes of patients with left ventricle non-compaction.
Completed
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Patients > 18 years, referred for CMR for further evaluation of cardiomyopathy.
Exclusion criteria
- patients with intracardiac masses, pericardial diseases and congenital heart diseases were excluded from the study.
Treatment and study plan
Primary outcomes
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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.
Secondary outcomes
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All cause-mortality, heart failure hospitalization, and arrhythmia hospitalization.
Time frame: 37 months
All cause-mortality, heart failure hospitalization, and arrhythmia hospitalization.
Sponsors and collaborators
Lead sponsor
Aga Khan University Hospital, Pakistan
Other
Registry information
Important dates
- Study start
- 2011
- Primary completion
- 2020
- Study completion
- 2020
- First posted
- Mar 16, 2022
- Registry last updated
- Mar 16, 2022
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.