Acute Myocardial InfarctionNCT01359306
Right Ventricular Damage in Cardiovascular Magnetic Resonance
An observational study of Acute Myocardial Infarction, run by University of Leipzig.
Trial summary
The purpose of this study is to determine the predictors of right ventricular damage (RVD) assessed by wall motion abnormalities, edema, myocardial salvage and delayed enhancement (DE)cardiac magnetic resonance imaging in acute ST-elevation myocardial infarction (STEMI) and its prognostic significance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myocardial Infarction
- How many people
- 524 participants
- Where
- No sites listed yet
- Study dates
- Feb 2006to May 2008
- 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: 524 consecutive patients with ST elevation myocardial infarction.
Who may be able to join
- Onset of symptoms <12 h before angioplasty.
- ST-segment elevation of at least 0.1 mV in ≥2 extremity leads or at least 0.2 mV in ≥2 precordial leads.
Who cannot join
- Contraindications to CMR as implanted defibrillators, pacemakers, ferromagnetic intracranial metallic implants or pulmonary metallic splints and claustrophobia. A further exclusion criterion was prior fibrinolysis.
About this study
Official title: Right Ventricular Damage in ST-Elevation Myocardial Infarction. Risk Stratification by Visualization of Wall Motion, Edema and Delayed Enhancement Cardiovascular Magnetic Resonance
The purpose of this study is to determine the predictors of right ventricular damage (RVD) assessed by wall motion abnormalities, edema, myocardial salvage and delayed enhancement (DE)cardiac magnetic resonance imaging in acute ST-elevation myocardial infarction (STEMI) and its prognostic significance.
The investigators hypothesize that ischemia related changes of the myocardium are also visible in the right ventricle and that they have an impact on patient outcome.
- Conditions
- Acute Myocardial Infarction
- Keywords
- Acute myocardial infarction, Right ventricular infarction, Cardiovascular Magnetic Resonance, Prognosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Cardiac Event
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2011 (estimated)
- Study startFeb 2006
- Primary completionMay 2008
- Study completionMay 2008
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 Acute 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
- Retrospective
- Enrolment
- 524 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Investigators
- Matthias Grothoff, MD, Principal investigator, Heart Center Leipzig - University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01359306
- Sponsor's protocol ID
- RV-Damage 1/2007
- Status last verified
- May 2011
- First submitted
- 20 May 2011
- Last updated
- 24 May 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Grothoff M, Elpert C, Hoffmann J, Zachrau J, Lehmkuhl L, de Waha S, Desch S, Eitel I, Mende M, Thiele H, Gutberlet M. Right ventricular injury in ST-elevation myocardial infarction: risk stratification by visualization of wall motion, edema, and delayed-enhancement cardiac magnetic resonance. Circ Cardiovasc Imaging. 2012 Jan;5(1):60-8. doi: 10.1161/CIRCIMAGING.111.967810. Epub 2011 Nov 11.
PubMed 22080332
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Right Ventricular Damage in ST-Elevation Myocardial Infarction. Risk Stratification by Visualization of Wall Motion, Edema and Delayed Enhancement Cardiovascular Magnetic Resonance
- ClinicalTrials.gov ID
- NCT01359306
- Acronym / sponsor ID
- RV-Damage 1/2007
- Conditions
- Acute Myocardial Infarction
- Keywords
- Acute myocardial infarction, Right ventricular infarction, Cardiovascular Magnetic Resonance, Prognosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 524 participants (actual)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Study start
- Feb 2006
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 24 May 2011 (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 purpose of this study is to determine the predictors of right ventricular damage (RVD) assessed by wall motion abnormalities, edema, myocardial salvage and delayed enhancement (DE)cardiac magnetic resonance imaging in acute ST-elevation myocardial infarction (STEMI) and its prognostic significance.
The investigators hypothesize that ischemia related changes of the myocardium are also visible in the right ventricle and that they have an impact on patient outcome.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 524 consecutive patients with ST elevation myocardial infarction.
Key inclusion criteria (2 listed)
- Onset of symptoms <12 h before angioplasty.
- ST-segment elevation of at least 0.1 mV in ≥2 extremity leads or at least 0.2 mV in ≥2 precordial leads.
Key exclusion criteria (1 listed)
- Contraindications to CMR as implanted defibrillators, pacemakers, ferromagnetic intracranial metallic implants or pulmonary metallic splints and claustrophobia. A further exclusion criterion was prior fibrinolysis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Major Adverse Cardiac Event
Time frame: 30 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 24 May 2011.
- Derived from this study: PubMed 22080332Grothoff M, Elpert C, Hoffmann J, Zachrau J, Lehmkuhl L, de Waha S, Desch S, Eitel I, Mende M, Thiele H, Gutberlet M. Right ventricular injury in ST-elevation myocardial infarction: risk stratification by visualization of wall motion, edema, and delayed-enhancement cardiac magnetic resonance. Circ Cardiovasc Imaging. 2012 Jan;5(1):60-8. doi: 10.1161/CIRCIMAGING.111.967810. Epub 2011 Nov 11.
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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.
Matthias Grothoff, MD principal investigator
Heart Center Leipzig - University Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myocardial Infarction, run by University of Leipzig.
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 24 May 2011. Status can change between updates, so confirm with the study contact before making plans.
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 Event (time frame: 30 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 NCT01359306, 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 24 May 2011.