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Edema and Fibrosis CMR Imaging in Cardiomyopathy

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ClinicalTrials.gov Identifier: NCT03534726
Recruitment Status : Recruiting
First Posted : May 23, 2018
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

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
Cardiomyopathies Device: 7 T CMR

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Edema and Fibrosis Cardiac Magnetic Resonance Imaging in Cardiomyopathy
Actual Study Start Date : February 1, 2018
Estimated Primary Completion Date : January 31, 2023
Estimated Study Completion Date : January 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiomyopathy Edema

Group/Cohort 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




Primary Outcome Measures :
  1. ejection fraction [ Time Frame: 5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
The eligible population are cardiomyopathy patients and normal volunteers.
Criteria

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 claustrophophia)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03534726


Locations
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United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Walter R Witschey, Ph.D.    215-662-2310    witschey@pennmedicine.upenn.edu   
Sponsors and Collaborators
University of Pennsylvania

Additional Information:

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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03534726     History of Changes
Other Study ID Numbers: 827516
First Posted: May 23, 2018    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Cardiomyopathies
Heart Diseases
Cardiovascular Diseases