NCT03534726

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for all trials

Timeline
20mo left

Started Feb 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress83%
Feb 2018Dec 2027

Study Start

First participant enrolled

February 1, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 11, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 23, 2018

Completed
8.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

February 6, 2026

Status Verified

February 1, 2026

Enrollment Period

8.9 years

First QC Date

May 11, 2018

Last Update Submit

February 5, 2026

Conditions

Cardiomyopathies

Outcome Measures

Primary Outcomes (1)

  • ejection fraction

    5 years

Study Arms (2)

Patients

Patients with cardiomyopathy

Device: 7 T CMR

Normal subjects

No prior history of heart disease.

Device: 7 T CMR

Interventions

7 T CMRDEVICE

7 tesla MRI device

Normal subjectsPatients

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The eligible population are cardiomyopathy patients and normal volunteers.

You may qualify if:

  • Subjects between the ages of 20-70 years old

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Cardiomyopathies

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2018

First Posted

May 23, 2018

Study Start

February 1, 2018

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Last Updated

February 6, 2026

Record last verified: 2026-02

Locations

US(1)