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OpenTrials
Completed

NCT Number: NCT01820000

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

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

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Key information

Conditions

Heart Attack Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan Hospital

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diffusion Weighted Imaging with MRI scans

Procedure

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 outcomes

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

    Time frame: single occurance

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

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2014
Study completion
2016
First posted
Mar 28, 2013
Registry last updated
Oct 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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