ST-Elevation Myocardial InfarctionNCT00952224
Myocardial Salvage Assessed by Cardiovascular Magnetic Resonance - Impact on Outcome
An observational study of ST-Elevation Myocardial Infarction, run by University of Leipzig at 1 site in Germany.
Trial summary
In acute myocardial infarction cardiovascular magnetic resonance imaging can retrospectively detect the myocardium at risk and the irreversible injury. This allows for quantifying the extent of salvaged myocardium after reperfusion as a potential strong end point for clinical trials and outcome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ST-Elevation Myocardial Infarction
- What is being tested?
- magnetic resonance imaging
- How many people
- 267 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2006to Mar 2009
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cohort of patients with ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention
Who may be able to join
- ST-elevation myocardial infarction < 12 hours
- primary percutaneous coronary intervention
Who cannot join
- previous myocardial infarction
- prior fibrinolysis
- contraindications to CMR at study entry (such as implanted pacemakers, defibrillators, claustrophobia or metallic intracranial implants)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prognostic Significance and Determinants of Myocardial Salvage Assessed by Cardiovascular Magnetic Resonance in Acute Reperfused Myocardial Infarction
In acute myocardial infarction cardiovascular magnetic resonance imaging can retrospectively detect the myocardium at risk and the irreversible injury. This allows for quantifying the extent of salvaged myocardium after reperfusion as a potential strong end point for clinical trials and outcome. The aim of the present study is to determine the prognostic significance and determinants of myocardial salvage assessed by CMR in reperfused ST-elevation myocardial infarction (STEMI).
- Conditions
- ST-Elevation Myocardial Infarction
- Being tested
- magnetic resonance imaging
- Keywords
- myocardial salvage, cardiovascular magnetic resonance, magnetic resonance imaging, myocardial infarction, prognosis
- Medical subject headings
- ST Elevation Myocardial Infarction, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
magnetic resonance imagingOther
magnetic resonance imaging is used for prognosis assessment
| Study group | Role | What they receive |
|---|---|---|
| Acute myocardial infarction patients | Patients undergoing primary percutaneous coronary intervention in ST-elevation myocardial infarction plus magnetic resonance imaging Receives: Other: magnetic resonance imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiac events
Measured: 6 months
Secondary outcomes (1)
Mortality
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2009 (estimated)
- Study startNov 2006
- Primary completionMay 2008
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ST-Elevation 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
- 267 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Investigators
- Ingo Eitel, MD, Principal investigator, Heart Center Leipzig - University HospitalHolger Thiele, MD, Study director, Heart Center Leipzig - University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00952224
- Sponsor's protocol ID
- Leipzig MR 1
- Status last verified
- Aug 2009
- First submitted
- 3 Aug 2009
- Last updated
- 6 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Eitel I, Desch S, de Waha S, Fuernau G, Gutberlet M, Schuler G, Thiele H. Long-term prognostic value of myocardial salvage assessed by cardiovascular magnetic resonance in acute reperfused myocardial infarction. Heart. 2011 Dec;97(24):2038-45. doi: 10.1136/heartjnl-2011-300098. Epub 2011 Oct 11.
PubMed 21990384Eitel I, Desch S, Fuernau G, Hildebrand L, Gutberlet M, Schuler G, Thiele H. Prognostic significance and determinants of myocardial salvage assessed by cardiovascular magnetic resonance in acute reperfused myocardial infarction. J Am Coll Cardiol. 2010 Jun 1;55(22):2470-9. doi: 10.1016/j.jacc.2010.01.049.
PubMed 20510214
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Significance and Determinants of Myocardial Salvage Assessed by Cardiovascular Magnetic Resonance in Acute Reperfused Myocardial Infarction
- ClinicalTrials.gov ID
- NCT00952224
- Acronym / sponsor ID
- Leipzig MR 1
- Conditions
- ST-Elevation Myocardial Infarction
- Keywords
- myocardial salvage, cardiovascular magnetic resonance, magnetic resonance imaging, myocardial infarction, prognosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 267 participants (actual)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Study start
- Nov 2006
- Primary completion
- May 2008 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 6 Aug 2009 (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.
In acute myocardial infarction cardiovascular magnetic resonance imaging can retrospectively detect the myocardium at risk and the irreversible injury. This allows for quantifying the extent of salvaged myocardium after reperfusion as a potential strong end point for clinical trials and outcome. The aim of the present study is to determine the prognostic significance and determinants of myocardial salvage assessed by CMR in reperfused ST-elevation myocardial infarction (STEMI).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute myocardial infarction patients | – | Other: magnetic resonance imagingPatients undergoing primary percutaneous coronary intervention in ST-elevation myocardial infarction plus magnetic resonance imaging |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cohort of patients with ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention
Key inclusion criteria (2 listed)
- ST-elevation myocardial infarction < 12 hours
- primary percutaneous coronary intervention
Key exclusion criteria (3 listed)
- previous myocardial infarction
- prior fibrinolysis
- contraindications to CMR at study entry (such as implanted pacemakers, defibrillators, claustrophobia or metallic intracranial implants)
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 |
|---|---|---|
| magnetic resonance imagingmagnetic resonance imaging is used for prognosis assessment | Other | Acute myocardial infarction patients |
Primary outcome
Major adverse cardiac events
Time frame: 6 months
1 secondary outcome
Mortality
Time frame: 6 months
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 6 Aug 2009.
- Derived from this study: PubMed 21990384Eitel I, Desch S, de Waha S, Fuernau G, Gutberlet M, Schuler G, Thiele H. Long-term prognostic value of myocardial salvage assessed by cardiovascular magnetic resonance in acute reperfused myocardial infarction. Heart. 2011 Dec;97(24):2038-45. doi: 10.1136/heartjnl-2011-300098. Epub 2011 Oct 11.
- Derived from this study: PubMed 20510214Eitel I, Desch S, Fuernau G, Hildebrand L, Gutberlet M, Schuler G, Thiele H. Prognostic significance and determinants of myocardial salvage assessed by cardiovascular magnetic resonance in acute reperfused myocardial infarction. J Am Coll Cardiol. 2010 Jun 1;55(22):2470-9. doi: 10.1016/j.jacc.2010.01.049.
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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.
Ingo Eitel, MD principal investigator
Heart Center Leipzig - University Hospital
Holger Thiele, MD study director
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 ST-Elevation 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 3 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 6 Aug 2009. 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?
Major adverse cardiac events (time frame: 6 months). 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 NCT00952224, which also lists 2 linked publications.
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 6 Aug 2009.