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Efficacy of Non Contrast DWI(Diffusion Weighted Imaging) Imaging Compared to DMR-DE

Primary Purpose

Heart Attack

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Diffusion Weighted Imaging with MRI scans
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Heart Attack

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Males and females 21 years of age and older
  • Healthy volunteers
  • subjects with a prior history of heart attack and prior CMR-DE imaging.

Exclusion Criteria:

  • Women who are pregnant
  • Subjects with GFR < 60 ml/min/1.73m2
  • Subjects with ICD
  • Subjects with coronary stents incompatible with 3T

Sites / Locations

  • University of Michigan Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diffusion Weighted Imaging with MRI scans

Arm Description

Subjects 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
February 5, 2013
Last Updated
October 18, 2016
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT01820000
Brief Title
Efficacy of Non Contrast DWI(Diffusion Weighted Imaging) Imaging Compared to DMR-DE
Official Title
Prospective Study to Obtain Preliminary Data to Determine the Efficacy of Non Contrast DWI Imaging Compared to CMR-DE
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Use of MRI and DWI to diagnose cardiac scarring after heart attack.
Detailed Description
To discover new information about MRI (magnetic resonance imaging) called DWI (diffusion weighted imaging) and its ability to diagnose cardiac scarring. CMR-DE (cardiac MR with delayed contrast enhancement) evaluates if there has been scarring in the heart muscle following a heart attack. Subjects are injected with a contrast medication that makes the scarring visible if present. To prove the efficacy of DWI (diffusion weighted imaging) to provide the same images that CMR-DE (cardiac magnetic resonance with delayed contrast enhancement) provides.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Attack

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diffusion Weighted Imaging with MRI scans
Arm Type
Experimental
Arm Description
Subjects 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.
Intervention Type
Procedure
Intervention Name(s)
Diffusion Weighted Imaging with MRI scans
Intervention Description
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.
Primary Outcome Measure Information:
Title
presence and apparent diffusion coefficient (ADC) quantification of scar on (DWI) diffusion weighted image
Description
Confirm the efficacy of diffusion weighted imaging in providing imaging that shows cardiac scarring without the injection of contrast.
Time Frame
single occurance

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Males and females 21 years of age and older Healthy volunteers subjects with a prior history of heart attack and prior CMR-DE imaging. Exclusion Criteria: Women who are pregnant Subjects with GFR < 60 ml/min/1.73m2 Subjects with ICD Subjects with coronary stents incompatible with 3T
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jadranka Stojanovska, M.D.
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Efficacy of Non Contrast DWI(Diffusion Weighted Imaging) Imaging Compared to DMR-DE

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