RECRUITING

Dilated Cardiomyopathy-Cardiac Magnetic Resonance (DCM-CMR) Ancillary Study

Conditions

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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

The Dilated Cardiomyopathy-Cardiac Magnetic Resonance (DCM-CMR) Study is an ancillary study from the parent study, DCM Precision Medicine Study. The rationale for the DCM-CMR study is to leverage cardiac magnetic resonance (CMR) imaging to detect earliest findings of DCM in the at-risk family members enrolled into the parent study.

Official Title

Precision Medicine for Dilated Cardiomyopathy-Cardiac Magnetic Resonance to Identify Early Family Phenotypes

Quick Facts

Study Start:2021-04-01

Study Completion:2026-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04638621

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:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. The FDR's proband was enrolled in the DCM Precision Medicine Study at 1 of 9 participating sites, or exceptions granted by study PI. 2. The FDR's proband has had one or more variants identified, including P, LP and VUS. 3. The FDR is able report to one of the participating sites for study enrollment. 4. The FDR has no current contraindication for CMR (glomerular filtration rate (GFR) \<30 mL/min/1.73 m2, non-compatible device implant, or allergy to gadolinium contrast). 5. The FDR has had no prior heart transplant. 6. The FDR is ≥18 years of age. 7. All races/ethnicity 8. Ability to give informed consent. 9. Ability to communicate in English. 10. Subject is not pregnant (CMR may be conducted 3-6 months post delivery) 11. Willingness to participate in a family-based study (subject willing to interact with OSU).	1. Coronary artery disease (CAD) causing ischemic cardiomyopathy (\> 50% narrowing, any major epicardial coronary artery). 2. Primary valvular disease. 3. Adriamycin or other cardiotoxic drug exposure. 4. Other forms of cardiomyopathy: Hypertrophic, Restrictive, or Arrhythmogenic Right Ventricular Dysplasia/Cardiomyopathy. 5. Congenital heart disease. 6. Other detectable causes of dilated cardiomyopathy, including sarcoid and hemochromatosis. 7. Other active multisystem disease, even if very rare, that may plausibly cause DCM (e.g., hypereosinophilic syndrome, cardiac involvement with connective tissue disease, Loeffler's endocarditis, endomyocardial fibrosis, etc) are excluded. Please call the PI to discuss if uncertain or not clear. 8. Severe and untreated or untreatable hypertension (systolic blood pressures routinely greater than 180 mm Hg and/or diastolic blood pressures greater than 120 mm Hg, and if resistant to multidrug treatment). This includes profound hypertension associated with other multisystem disease (e.g., scleroderma, other vasculitides, etc).

Inclusion Criteria

Exclusion Criteria

1. The FDR's proband was enrolled in the DCM Precision Medicine Study at 1 of 9 participating sites, or exceptions granted by study PI.
2. The FDR's proband has had one or more variants identified, including P, LP and VUS.
3. The FDR is able report to one of the participating sites for study enrollment.
4. The FDR has no current contraindication for CMR (glomerular filtration rate (GFR) \<30 mL/min/1.73 m2, non-compatible device implant, or allergy to gadolinium contrast).
5. The FDR has had no prior heart transplant.
6. The FDR is ≥18 years of age.
7. All races/ethnicity
8. Ability to give informed consent.
9. Ability to communicate in English.
10. Subject is not pregnant (CMR may be conducted 3-6 months post delivery)
11. Willingness to participate in a family-based study (subject willing to interact with OSU).

1. Coronary artery disease (CAD) causing ischemic cardiomyopathy (\> 50% narrowing, any major epicardial coronary artery).
2. Primary valvular disease.
3. Adriamycin or other cardiotoxic drug exposure.
4. Other forms of cardiomyopathy: Hypertrophic, Restrictive, or Arrhythmogenic Right Ventricular Dysplasia/Cardiomyopathy.
5. Congenital heart disease.
6. Other detectable causes of dilated cardiomyopathy, including sarcoid and hemochromatosis.
7. Other active multisystem disease, even if very rare, that may plausibly cause DCM (e.g., hypereosinophilic syndrome, cardiac involvement with connective tissue disease, Loeffler's endocarditis, endomyocardial fibrosis, etc) are excluded. Please call the PI to discuss if uncertain or not clear.
8. Severe and untreated or untreatable hypertension (systolic blood pressures routinely greater than 180 mm Hg and/or diastolic blood pressures greater than 120 mm Hg, and if resistant to multidrug treatment). This includes profound hypertension associated with other multisystem disease (e.g., scleroderma, other vasculitides, etc).

Contacts and Locations

Study Contact

Principal Investigator

CONTACT

1-614-688-1388

DCM.Research@osumc.edu

Clinical Research Manager

CONTACT

1-614-688-9815

DCM.Research@osumc.edu

Principal Investigator

Ray Hershberger, MD

PRINCIPAL_INVESTIGATOR

Ohio State University

Karolina Zareba, MD

PRINCIPAL_INVESTIGATOR

Ohio State University

Daniel Kinnamon, PhD

PRINCIPAL_INVESTIGATOR

Ohio State University

Study Locations (Sites)

The Ohio State University

Columbus, Ohio, 43210

United States

Collaborators and Investigators

Sponsor: Ohio State University

Ray Hershberger, MD, PRINCIPAL_INVESTIGATOR, Ohio State University
Karolina Zareba, MD, PRINCIPAL_INVESTIGATOR, Ohio State University
Daniel Kinnamon, PhD, PRINCIPAL_INVESTIGATOR, Ohio State 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 Date2021-04-01

Study Completion Date2026-04

Study Record Updates

Study Start Date2021-04-01

Study Completion Date2026-04

Terms related to this study

Additional Relevant MeSH Terms

Dilated Cardiomyopathy