Edema and Fibrosis CMR Imaging in Cardiomyopathy

• Sponsor: University of Pennsylvania (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03534726
• Collaborator: (none)
• Enrollment: 250
• Location: 1
• Anticipated Duration (Months): 60
• Patients Per Site Per Month: 4.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiomyopathies	Device: 7 T CMR

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 250 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Edema and Fibrosis Cardiac Magnetic Resonance Imaging in Cardiomyopathy
• Actual Study Start Date: Feb 1, 2018
• Anticipated Primary Completion Date: Jan 31, 2023
• Anticipated Study Completion Date: Jan 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Patients Patients with cardiomyopathy	Device: 7 T CMR; 7 tesla MRI device
Normal subjects No prior history of heart disease.	Device: 7 T CMR; 7 tesla MRI device

Outcome Measures

Primary Outcome Measures

1. ejection fraction [5 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 70 Years
• Sexes Eligible for Study: All

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

• University of Pennsylvania

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT03534726
• Other Study ID Numbers: 827516
• First Posted: May 23, 2018
• Last Update Posted: Aug 23, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• 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
• Additional relevant MeSH terms: Cardiomyopathies

Study Results

No Results Posted as of Aug 23, 2021