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NCT04424030 · ClinicalTrials.gov registry record
International Consortium for Multimodality Phenotyping in Adults With Non-compaction
A clinical trial of Non-Compaction Cardiomyopathy, sponsored by Stanford University.
- Recruiting
- Registry status
- 600
- Enrollment target
- 5
- Study locations
NCT04424030: Recruiting study of Non-Compaction Cardiomyopathy, sponsored by Stanford University.
NCT04424030 is a study of Non-Compaction Cardiomyopathy that is actively recruiting participants, run by Stanford University. The registered enrollment target is 600 participants. The trial reports 5 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04424030, a study of Non-Compaction Cardiomyopathy, is actively recruiting participants, sponsored by Stanford University.
- RECRUITING
- Registry status
- 600 participants
- Enrollment target
- 5
- Study locations
Study Summary
Non-compaction cardiomyopathy (NCCM) is a heterogeneous, poorly understood disorder characterized by a prominent inner layer of loose myocardial tissue, and associated with heart failure, stroke, severe rhythm irregularities and death. For a growing population diagnosed with NCCM there is a need for better risk stratification to appropriately allocate (or safely withhold) these impactful preventive measures. The goal of this international consortium is to improve care of patients with non-compaction cardiomyopathy. We hypothesize that comprehensive analysis of clinical, genetic, structural and functional information will improve risk stratification. In addition, we hypothesize that detailed structural analysis will allow for differentiation of pathological and benign patterns of non-compaction. In a large cohort of adult patients with suspected NCCM we will perform in-depth phenotyping, including clinical information, pedigree data, genetics, echocardiography and MRI, and follow patients for up to 3 years. We will apply machine-learning based analytics to develop predictive models and compare their performance to currently used models and treatment criteria. Secondly, in a subset of patients we will perform high-resolution cardiac CT for detailed structural characterization of the myocardial wall. We will investigate associations between myocardial structure and regional contractile function, as assessed by echo and MRI. The aim of this proposal is to identify a structural signature associated with pathological non-compaction and improve developed risk prediction models. Discovery of pathological structural signatures through innovative imaging techniques, in relation to myocardial contractility, will advance our understanding of NCCM.
Primary Outcome
Clinical neuro/systemic embolic event by autopsy, imaging or specialist evaluation
Conditions Studied
Interventions
- DIAGNOSTIC_TEST Echocardiography
- DIAGNOSTIC_TEST Magnetic resonance imaging (MRI)
- DIAGNOSTIC_TEST Computed tomography (CT)
Study Locations (5)
Other
- Erasmus Medical Center - Rotterdam
- Seoul National University Hospital - Seoul
California
- Stanford University - Palo Alto
Ohio
- Cleveland Clinic Foundation - Cleveland
Pennsylvania
- University of Pennsylvania - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 600 participants |
| Start Date | 2021-01-01 |
| Est. Completion | 2027-04-01 |
What NCT04424030 shows while recruiting
NCT04424030 is an observational study that tracks outcomes without assigning an intervention. The registered 600 participants enrollment target is mid-sized for trials with a published cap.
The record links to 1 condition, with Non-Compaction Cardiomyopathy appearing as the primary indexed condition, and to 3 interventions - of which Echocardiography is the first listed.
NCT04424030 lists 5 locations in 4 states (Other, California, Ohio).
Frequently Asked Questions
What is clinical trial NCT04424030 about?
NCT04424030 is a clinical study titled "International Consortium for Multimodality Phenotyping in Adults With Non-compaction". Non-compaction cardiomyopathy (NCCM) is a heterogeneous, poorly understood disorder characterized by a prominent inner layer of loose myocardial tissue, and associated with heart failure, stroke, severe rhythm irregularities and death. For a growing population diagnosed with NCCM there is a need for...
What is the current status of trial NCT04424030?
This trial is currently recruiting. The enrollment target is 600 participants. The study started on 2021-01-01. Estimated completion is 2027-04-01.
What conditions does trial NCT04424030 study?
This clinical trial studies the following conditions: Non-Compaction Cardiomyopathy.
What interventions are being tested in trial NCT04424030?
The interventions under investigation include: Echocardiography (DIAGNOSTIC_TEST), Magnetic resonance imaging (MRI) (DIAGNOSTIC_TEST), Computed tomography (CT) (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT04424030?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04424030 being conducted?
This trial has 5 study locations across California, Ohio, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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