Completed

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

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What is being tested

Diffusion Weighted Imaging with MRI scans

Procedure
Who is being recruted

Cardiovascular Diseases+7

+ Heart Diseases

+ Infarction

Over 21 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Diagnostic Study

Interventional
Study Start: December 2009
See protocol details

Summary

Principal SponsorUniversity of Michigan
Last updated: October 19, 2016
Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 2009

Actual date on which the first participant was enrolled.

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.

NCT01820000
Principal SponsorUniversity of Michigan
Last updated: October 19, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

23 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Diagnostic Study

Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 21 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Cardiovascular DiseasesHeart DiseasesInfarctionIschemiaNecrosisPathologic ProcessesPathological Conditions, Signs and SymptomsVascular DiseasesMyocardial IschemiaMyocardial Infarction

Criteria

3 inclusion criteria required to participate
Healthy volunteers
Males and females 21 years of age and older
subjects with a prior history of heart attack and prior CMR-DE imaging
4 exclusion criteria prevent from participating
Subjects with GFR < 60 ml/min/1.73m2
Subjects with ICD
Subjects with coronary stents incompatible with 3T
Women who are pregnant

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

University of Michigan Hospital

Ann Arbor, United StatesOpen University of Michigan Hospital in Google Maps
CompletedOne Study Center