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

• Sponsor: University of Michigan (Other)
• Overall Status: Completed
• CT.gov ID: NCT01820000
• Collaborator: (none)
• Enrollment: 23
• Location: 1
• Arm: 1
• Duration (Months): 79
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

Use of MRI and DWI to diagnose cardiac scarring after heart attack.

Condition or Disease	Intervention/Treatment	Phase
Heart Attack	Procedure: Diffusion Weighted Imaging with MRI scans	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 23 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Prospective Study to Obtain Preliminary Data to Determine the Efficacy of Non Contrast DWI Imaging Compared to CMR-DE
• Study Start Date: Dec 1, 2009
• Actual Primary Completion Date: Sep 1, 2014
• Actual Study Completion Date: Jul 1, 2016

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Diffusion Weighted Imaging with MRI scans 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.

Procedure: Diffusion Weighted Imaging with MRI scans; 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.

Outcome Measures

Primary Outcome Measures

1. presence and apparent diffusion coefficient (ADC) quantification of scar on (DWI) diffusion weighted image [single occurance]

   Confirm the efficacy of diffusion weighted imaging in providing imaging that shows cardiac scarring without the injection of contrast.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Michigan Hospital	Ann Arbor	Michigan	United States	48109

Sponsors and Collaborators

• University of Michigan

Investigators

• Principal Investigator: Jadranka Stojanovska, M.D., University of Michigan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jadranka Stojanovska, M.D., Principal Investigator, University of Michigan
• ClinicalTrials.gov Identifier: NCT01820000
• Other Study ID Numbers: HUM00032804
• First Posted: Mar 28, 2013
• Last Update Posted: Oct 19, 2016
• Last Verified: Oct 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Myocardial Infarction

Study Results

No Results Posted as of Oct 19, 2016