Myocardial InfarctionNCT00794300
Reproducibility of Magnetic Resonance Myocardial Salvage Index
An observational study of Myocardial Infarction, run by University of Leipzig at 1 site in Germany.
Trial summary
The myocardial salvage assessed by using multimodal cardiac magnetic resonance imaging is a rather new technique which can be used as a surrogate endpoint to reduce the sample size in studies comparing different reperfusion strategies in myocardial infarction. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- second magnetic resonance imaging scan
- Type of treatment
- Medical device
- How many people
- 250 participants
- Where
- 1 siteGermany
- Study dates
- 1 Nov 2008to 1 May 2010
- Phase
- Observational
- 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ST-elevation myocardial infarction
Who may be able to join
- ST-elevation myocardial infarction
- Primary percutaneous coronary intervention
Who cannot join
- Contraindications for magnetic resonance imaging
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reproducibility of Myocardial Salvage Index in Acute Myocardial Infarction by Cardiac Magnetic Resonance Imaging
The myocardial salvage assessed by using multimodal cardiac magnetic resonance imaging is a rather new technique which can be used as a surrogate endpoint to reduce the sample size in studies comparing different reperfusion strategies in myocardial infarction. As reproducibility of myocardial salvage has not been evaluated appropriately, we aim to scan 20 patients on 2 subsequent days to evaluate reproducibility of myocardial salvage index.
- Conditions
- Myocardial Infarction
- Being tested
- second magnetic resonance imaging scan
- Keywords
- reproducibility, contrast agent, magnetic resonance imaging, infarct size, myocardial salvage index, myocardial salvage assessment
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
second magnetic resonance imaging scanDevice
| Study group | Role | What they receive |
|---|---|---|
| Acute myocardial infarction patients | Not described Receives: Device: second magnetic resonance imaging scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial salvage index reproducibility
Measured: 2 days
Secondary outcomes (3)
infarct size reproducibility
Measured: 2 days
area at risk reproducibility
Measured: 2 days
microvascular obstruction reproducibility
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2008 (estimated)
- Study start1 Nov 2008
- Primary completion1 Nov 2009
- Study completion1 May 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Holger Thiele, University of Leipzig
- Investigators
- Holger Thiele, MD, Principal investigator, Heart Center Leipzig - University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00794300
- Sponsor's protocol ID
- Repro100
- Status last verified
- Jun 2018
- First submitted
- 19 Nov 2008
- Last updated
- 26 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Desch S, Engelhardt H, Meissner J, Eitel I, Sareban M, Fuernau G, de Waha S, Grothoff M, Gutberlet M, Schuler G, Thiele H. Reliability of myocardial salvage assessment by cardiac magnetic resonance imaging in acute reperfused myocardial infarction. Int J Cardiovasc Imaging. 2012 Feb;28(2):263-72. doi: 10.1007/s10554-011-9802-9. Epub 2011 Jan 30.
PubMed 21279689
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reproducibility of Myocardial Salvage Index in Acute Myocardial Infarction by Cardiac Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT00794300
- Acronym / sponsor ID
- Repro100
- Conditions
- Myocardial Infarction
- Keywords
- reproducibility, contrast agent, magnetic resonance imaging, infarct size, myocardial salvage index, myocardial salvage assessment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Study start
- 1 Nov 2008 (actual)
- Primary completion
- 1 Nov 2009 (actual)
- Study completion
- 1 May 2010 (actual)
- First posted
- 20 Nov 2008 (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.
The myocardial salvage assessed by using multimodal cardiac magnetic resonance imaging is a rather new technique which can be used as a surrogate endpoint to reduce the sample size in studies comparing different reperfusion strategies in myocardial infarction. As reproducibility of myocardial salvage has not been evaluated appropriately, we aim to scan 20 patients on 2 subsequent days to evaluate reproducibility of myocardial salvage index.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute myocardial infarction patients | – | Device: second magnetic resonance imaging scan |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ST-elevation myocardial infarction
Key inclusion criteria (2 listed)
- ST-elevation myocardial infarction
- Primary percutaneous coronary intervention
Key exclusion criteria (1 listed)
- Contraindications for magnetic resonance imaging
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 |
|---|---|---|
| second magnetic resonance imaging scan | Device | Acute myocardial infarction patients |
Primary outcome
Myocardial salvage index reproducibility
Time frame: 2 days
3 secondary outcomes
infarct size reproducibility
Time frame: 2 days
area at risk reproducibility
Time frame: 2 days
microvascular obstruction reproducibility
Time frame: 2 days
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 26 Jun 2018.
- Derived from this study: PubMed 21279689Desch S, Engelhardt H, Meissner J, Eitel I, Sareban M, Fuernau G, de Waha S, Grothoff M, Gutberlet M, Schuler G, Thiele H. Reliability of myocardial salvage assessment by cardiac magnetic resonance imaging in acute reperfused myocardial infarction. Int J Cardiovasc Imaging. 2012 Feb;28(2):263-72. doi: 10.1007/s10554-011-9802-9. Epub 2011 Jan 30.
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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.
Holger Thiele, MD principal investigator
Heart Center Leipzig - University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Infarction, run by University of Leipzig at 1 site in Germany.
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 2 inclusion and 1 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 26 Jun 2018. 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 Germany. 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?
Myocardial salvage index reproducibility (time frame: 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00794300, which also lists 1 linked publication.
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 26 Jun 2018.