Efficacy of Non Contrast DWI(Diffusion Weighted Imaging) Imaging Compared to DMR-DE
Prospective Study to Obtain Preliminary Data to Determine the Efficacy of Non Contrast DWI Imaging Compared to CMR-DE
1 other identifier
interventional
23
1 country
1
Brief Summary
Use of MRI and DWI to diagnose cardiac scarring after heart attack.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2009
Longer than P75 for not_applicable
1 active site
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 Start
First participant enrolled
December 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 5, 2013
CompletedFirst Posted
Study publicly available on registry
March 28, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2016
CompletedOctober 19, 2016
October 1, 2016
4.8 years
February 5, 2013
October 18, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
presence and apparent diffusion coefficient (ADC) quantification of scar on (DWI) diffusion weighted image
Confirm the efficacy of diffusion weighted imaging in providing imaging that shows cardiac scarring without the injection of contrast.
single occurance
Study Arms (1)
Diffusion Weighted Imaging with MRI scans
EXPERIMENTALSubjects will undergo a MRI (magnetic resonance imaging) scan where DWI (diffusion weighted imaging) will be performed. Subjects will not receive contrast during this sequence, but will receive contrast as standard MRI protocol.
Interventions
Subjects will have an MRI(magnetic resonance imaging)performed. This sequence will take no longer than 10 to 15 minutes to complete. Only DWI (diffusion weighted imaging) will be added to the standard cardiac MR protocol for viability which requires contrast injection. DWI(diffusion weighted imaging) sequence does not require contrast injection.
Eligibility Criteria
You may qualify if:
- Males and females 21 years of age and older
- Healthy volunteers
- subjects with a prior history of heart attack and prior CMR-DE imaging.
You may not qualify if:
- Women who are pregnant
- Subjects with GFR \< 60 ml/min/1.73m2
- Subjects with ICD
- Subjects with coronary stents incompatible with 3T
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Michigan Hospital
Ann Arbor, Michigan, 48109, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jadranka Stojanovska, M.D.
University of Michigan
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 5, 2013
First Posted
March 28, 2013
Study Start
December 1, 2009
Primary Completion
September 1, 2014
Study Completion
July 1, 2016
Last Updated
October 19, 2016
Record last verified: 2016-10
Data Sharing
- IPD Sharing
- Will not share