- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03534726
Edema and Fibrosis CMR Imaging in Cardiomyopathy
February 5, 2026 updated by: University of Pennsylvania
Edema and Fibrosis Cardiac Magnetic Resonance Imaging in Cardiomyopathy
7 Tesla MRI is a new magnetic field strength that has become available at Penn for cardiovascular MRI.
This new scanner has potential to improve assessment of cardiovascular disease due to its increased signal-to-noise ratio, higher spatial resolution, and response to magnetic properties of tissue at high field.
The purpose of this study is to assess the feasibility of 7 T CMR.
Secondly, we wish to investigate its use, to improve clinical and research MRI.
Altogether, 7 T may permit better clinical diagnosis of cardiomyopathy.
Study Overview
Study Type
Observational
Enrollment (Actual)
13
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania
-
-
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.
Eligibility Criteria
Ages Eligible for Study
20 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
The eligible population are cardiomyopathy patients and normal volunteers.
Description
Inclusion Criteria:
- Subjects between the ages of 20-70 years old
Exclusion Criteria:
- Advanced renal disease (estimated GFR rate < 30 mL/min) or hypersensitivity to gadolinium contrast agent.
- Presence of cardiac pacemaker or implanted cardioverter defibrillator
- Pregnancy
- Inability to provide informed consent
- Other contraindications to MRI (such as claustrophobia)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients
Patients with cardiomyopathy
|
7 tesla MRI device
|
|
Normal subjects
No prior history of heart disease.
|
7 tesla MRI device
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
ejection fraction
Time Frame: 5 years
|
5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 Major Dates
Study Start (Actual)
February 1, 2018
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2027
Study Registration Dates
First Submitted
May 11, 2018
First Submitted That Met QC Criteria
May 11, 2018
First Posted (Actual)
May 23, 2018
Study Record Updates
Last Update Posted (Actual)
February 6, 2026
Last Update Submitted That Met QC Criteria
February 5, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 827516
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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