Heart AttackNCT01820000
Efficacy of Non Contrast DWI(Diffusion Weighted Imaging) Imaging Compared to DMR-DE
A study testing Diffusion Weighted Imaging with MRI scans in people with Heart Attack, run by University of Michigan at 1 site in United States.
Trial summary
Use of MRI and DWI to diagnose cardiac scarring after heart attack. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Attack
- What is being tested?
- Diffusion Weighted Imaging with MRI scans
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2009to Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and females 21 years of age and older
- Healthy volunteers
- subjects with a prior history of heart attack and prior CMR-DE imaging.
Who cannot join
- Women who are pregnant
- Subjects with GFR < 60 ml/min/1.73m2
- Subjects with ICD
- Subjects with coronary stents incompatible with 3T
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Hospital
Ann Arbor, Michigan, 48109
About this study
Official title: Prospective Study to Obtain Preliminary Data to Determine the Efficacy of Non Contrast DWI Imaging Compared to CMR-DE
Use of MRI and DWI to diagnose cardiac scarring after heart attack.
Read the 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.
- Conditions
- Heart Attack
- Being tested
- Diffusion Weighted Imaging with MRI scans
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diffusion Weighted Imaging with MRI scansProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Diffusion Weighted Imaging with MRI scans | 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. Receives: Procedure: Diffusion Weighted Imaging with MRI scans |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: single occurance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2013 (estimated)
- Study startDec 2009
- Primary completionSep 2014
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart AttackStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jadranka Stojanovska, M.D., University of Michigan
- Investigators
- Jadranka Stojanovska, M.D., Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01820000
- Sponsor's protocol ID
- HUM00032804
- Status last verified
- Oct 2016
- First submitted
- 5 Feb 2013
- Last updated
- 19 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study to Obtain Preliminary Data to Determine the Efficacy of Non Contrast DWI Imaging Compared to CMR-DE
- ClinicalTrials.gov ID
- NCT01820000
- Acronym / sponsor ID
- HUM00032804
- Conditions
- Heart Attack
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Sep 2014 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 28 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diffusion Weighted Imaging with MRI scans | Experimental | Procedure: Diffusion Weighted Imaging with MRI scansSubjects 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males and females 21 years of age and older
- Healthy volunteers
- subjects with a prior history of heart attack and prior CMR-DE imaging.
Key exclusion criteria (4 listed)
- Women who are pregnant
- Subjects with GFR < 60 ml/min/1.73m2
- Subjects with ICD
- Subjects with coronary stents incompatible with 3T
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diffusion Weighted Imaging with MRI scansSubjects 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. | Procedure or surgery | Diffusion Weighted Imaging with MRI scans |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jadranka Stojanovska, M.D. principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diffusion Weighted Imaging with MRI scans in people with Heart Attack, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
presence and apparent diffusion coefficient (ADC) quantification of scar on (DWI) diffusion weighted image (time frame: single occurance). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2016.