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

Heart Attack Clinical Trial

Official title:

Prospective Study to Obtain Preliminary Data to Determine the Efficacy of Non Contrast DWI Imaging Compared to CMR-DE

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01820000
• Other study ID #: HUM00032804
• Status: Completed
• Phase: N/A
• First received: February 5, 2013
• Last updated: October 18, 2016
• Start date: December 2009
• Est. completion date: July 2016

Study information

• Verified date: October 2016
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: July 2016
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Heart Attack
• Myocardial Infarction

Intervention

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.

Locations

Country	Name	City	State
United States	University of Michigan Hospital	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No