Status:
RECRUITING
International Consortium for Multimodality Phenotyping in Adults With Non-compaction
Lead Sponsor:
Stanford University
Collaborating Sponsors:
The Cleveland Clinic
University of Pennsylvania
Conditions:
Non-Compaction Cardiomyopathy
Eligibility:
All Genders
18+ years
Brief 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, seve...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- ≥18 years old
- Hypertrabeculation of the left ventricle fulfilling the echo-based Jenni criteria of NCCM
- Clinical cardiac MRI examination performed or planned
- Exclusion Criteria (general cohort):
- Complex congenital disease (including transposition great arteries, tetralogy of Fallot, tricuspid atresia, truncus arteriosis, single ventricle, hypoplastic left heart, pulmonary atresia, double-outlet RV), neuromuscular disorders or isolated RV non-compaction
- Inability to provide informed consent
- Contra-indications to MRI, which apply if the clinical cardiac MRI has not yet been performed at the time of study enrollment: permanent pacemakers/ICDs, MRI contrast medium allergy, significant arrhythmia with highly irregular RR intervals, severe dyspnea with inability to lay flat/breath hold, inability to communicate with the MRI technician or follow commands for any reason (psychosis, agitation, etc.), other site-specific contra-indications to clinical MRI of the heart.
- Exclusion Criteria (cardiac CT examination):
- Age \<21 years
- Decompensated heart failure, or otherwise clinically unstable
- BMI\>40 kg/m2
- Pregnancy (or cannot be ruled out)
- Known iodine contrast medium allergy
- Kidney dysfunction: eGFR\<45 ml/min
- Thyroid disease: toxic multinodular goiter, Graves' disease, Hashimoto's thyroiditis
Exclusion
Key Trial Info
Start Date :
January 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2027
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT04424030
Start Date
January 1 2021
End Date
April 1 2027
Last Update
March 26 2025
Active Locations (5)
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1
Stanford University
Palo Alto, California, United States, 94304
2
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
3
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
4
Erasmus Medical Center
Rotterdam, Netherlands, 3015GD