RECRUITING

International Consortium for Multimodality Phenotyping in Adults With Non-compaction

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

International Consortium for Multimodality Phenotyping in Adults With Non-compaction

Quick Facts

Study Start:2021-01-01
Study Completion:2025-04-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04424030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * ≥18 years old
  2. * Hypertrabeculation of the left ventricle fulfilling the echo-based Jenni criteria of NCCM
  3. * Clinical cardiac MRI examination performed or planned
  4. * 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
  5. * Inability to provide informed consent
  6. * 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.
  7. * Age \<21 years
  8. * Decompensated heart failure, or otherwise clinically unstable
  9. * BMI\>40 kg/m2
  10. * Pregnancy (or cannot be ruled out)
  11. * Known iodine contrast medium allergy
  12. * Kidney dysfunction: eGFR\<45 ml/min
  13. * Thyroid disease: toxic multinodular goiter, Graves' disease, Hashimoto's thyroiditis
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Koen Nieman, MD, PhD
CONTACT
6507237476
knieman@stanford.edu
Katie DeSutter, BS
CONTACT
6507254151
ksutter@stanford.edu

Principal Investigator

Koen Nieman, MD, PhD
PRINCIPAL_INVESTIGATOR
Stanford University

Study Locations (Sites)

Stanford University
Palo Alto, California, 94304
United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States

Collaborators and Investigators

Sponsor: Stanford University

  • Koen Nieman, MD, PhD, PRINCIPAL_INVESTIGATOR, Stanford University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-01-01
Study Completion Date2025-04-01

Study Record Updates

Study Start Date2021-01-01
Study Completion Date2025-04-01

Terms related to this study

Keywords Provided by Researchers

  • Echocardiography
  • Magnetic resonance imaging
  • Computed tomography
  • Prognosis
  • Genetics

Additional Relevant MeSH Terms

  • Non-Compaction Cardiomyopathy