Consecutive Patients Undergoing CMRNCT01197677
European CMR Registry
An observational study of Consecutive Patients Undergoing CMR, run by Stiftung Institut fuer Herzinfarktforschung at 10 sites in 4 countries.
Trial summary
1. The main aim of the first specific protocol initiated by the European CMR registry, suspected CAD, is to demonstrate that patients presenting for work up of suspected coronary artery disease, which have a completely normal CMR scan will have a low risk for cardiovascular events. 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Consecutive Patients Undergoing CMR
- How many people
- 30,000 participants
- Where
- 10 sitesin 4 countries
- Study dates
- Apr 2009to Oct 2013
- 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: Consecutive patients undergoing CMR (enrolled into the "European clinical practice"-part of the registry Consecutive patients with suspected coronary artery disease or with hypertrophic cardiomyopathy (enrolled into the specific protocols "suspected-CAD" or "HCM-SCD").
Who may be able to join
- European clinical practice: Consecutive patients with accomplished CMR.
- -Suspected-CAD: Consecutive patients with suspected coronary artery disease undergoing a combined CMR protocol including evaluation of LV function, assessment of myocardial ische¬mia by adenosine stress perfusion or high-dose dobutamine CMR and detection of myocardial infarction using contrast-enhanced CMR.
- HCM-SCD: Consecutive patients with hypertrophic cardiomyopathy undergoing a combined CMR protocol including LV function, rest perfusion, and detection of myocardial scarring by contrast-enhanced CMR. The diagnosis of hypertrophic cardiomyopathy is based on the demonstration of a hypertrophied, non-dilated left ventricle (wall thickness of at least 15 mm in adults or the equivalent relative to body-surface area in children) in the absence of another cardiac or systemic disease capable of producing a similar degree of hypertrophy. In adult relatives of the patients with hypertrophic cardiomyo¬pathy, a wall thickness of 13 mm or more will be considered a criterion for diagnosis.
Who cannot join
- European clinical practice: None
- Suspected-CAD: Missing informed consent. Patients with known CAD by invasive coronary angiography or previous MI.
- HCM-SCD: Missing informed consent. Patients with known CAD by invasive coronary angiography or previous MI. Patients with left ventricular hypertrophy of other causes (e.g. hypertension, valvular heart disease)
Trial locations and contacts
10 sites in 4 countries.
10 sites in 4 countries
Germany7 sites
Klinikum Coburg
Coburg, 96450
Elisabeth Krankenhaus
Essen, 45138
Cardioangiologisches Centrum Bethanien
Frankfurt, 60389
Krankenhaus Agatharied
Hausham, 83734
Klinikum Ludwigsburg-Bietigheim
Ludwigsburg, 71640
Robert Bosch Medical Centre
Stuttgart, 70376
Klinikum Traunstein
Traunstein, 83278
Switzerland1 site
Centre Hospitalier Universitaire Vaudois
Lausanne, CH-1011
About this study
Official title: European Cardiovascular Magnetic Resonance Registry
- The main aim of the first specific protocol initiated by the European CMR registry, suspected CAD, is to demonstrate that patients presenting for work up of suspected coronary artery disease, which have a completely normal CMR scan will have a low risk for cardiovascular events.
- The main aim of the second specific protocol initiated by the European CMR registry, HCM-SCD, will be to evaluate CMR for risk stratification in hypertrophic cardiomyopathy(HCM).
- This registry is sought to collect data on the general use of CMR in the European clinical practice, its safety and its therapeutic implications in a high number of cases to 1) substantiate the clinical yield of CMR and 2) to define additional clinical questions worth to be investigated in detail as additional specific protocols in the future.
- Conditions
- Consecutive Patients Undergoing CMR
- Keywords
- CMR, Register, CAD, myocard scarring
What is being measured
The primary outcome is the main question the study is designed to answer.
collect data from a large number of patients regarding the general use of CMR in European clinical practice, its safety and its therapeutic implications
Measured: 01/01/2009-
Secondary outcomes (2)
to show that a normal CMR protocol (incl. LV wall motion at rest, stress ischemia, and scar detection) predicts a low risk of future cardiovascular events.
Measured: 01/01/2009
to evaluate if myocardial scarring assessed by contrast-enhanced CMR is a stronger predictor of adverse events during follow up than the general clinical markers of an adverse long term outcome in HCM.
Measured: 01/01/2009-
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2010 (estimated)
- Study startApr 2009
- Primary completionSep 2009
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Consecutive Patients Undergoing CMRStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 30,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stiftung Institut fuer Herzinfarktforschung
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Heiko Mahrholdt, MD, Principal investigator, Robert-Bosch-Medical-Center, Stuttgart, GermanyOliver Bruder, MD, Principal investigator, Elisabeth-Hospital, Essen, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01197677
- Sponsor's protocol ID
- Euro CMR
- Status last verified
- Sep 2016
- First submitted
- 7 Sep 2010
- Last updated
- 7 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Bruder O, Wagner A, Mahrholdt H. Lessons Learned from the European Cardiovascular Magnetic Resonance (EuroCMR) Registry Pilot Phase. Curr Cardiovasc Imaging Rep. 2010 Jun;3(3):171-174. doi: 10.1007/s12410-010-9016-x. Epub 2010 Apr 13.
PubMed 20461126Wagner A, Bruder O, Schneider S, Nothnagel D, Buser P, Pons-Lado G, Dill T, Hombach V, Lombardi M, van Rossum AC, Schwitter J, Senges J, Sabin GV, Sechtem U, Mahrholdt H, Nagel E. Current variables, definitions and endpoints of the European cardiovascular magnetic resonance registry. J Cardiovasc Magn Reson. 2009 Nov 5;11(1):43. doi: 10.1186/1532-429X-11-43.
PubMed 19891768Bruder O, Schneider S, Nothnagel D, Dill T, Hombach V, Schulz-Menger J, Nagel E, Lombardi M, van Rossum AC, Wagner A, Schwitter J, Senges J, Sabin GV, Sechtem U, Mahrholdt H. EuroCMR (European Cardiovascular Magnetic Resonance) registry: results of the German pilot phase. J Am Coll Cardiol. 2009 Oct 6;54(15):1457-66. doi: 10.1016/j.jacc.2009.07.003. Epub 2009 Aug 13.
PubMed 19682818
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- European Cardiovascular Magnetic Resonance Registry
- ClinicalTrials.gov ID
- NCT01197677
- Acronym / sponsor ID
- Euro CMR
- Conditions
- Consecutive Patients Undergoing CMR
- Keywords
- CMR, Register, CAD, myocard scarring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30,000 participants (actual)
- Lead sponsor
- Stiftung Institut fuer HerzinfarktforschungUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Sep 2009 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 9 Sep 2010 (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 main aim of the first specific protocol initiated by the European CMR registry, suspected CAD, is to demonstrate that patients presenting for work up of suspected coronary artery disease, which have a completely normal CMR scan will have a low risk for cardiovascular events.
- The main aim of the second specific protocol initiated by the European CMR registry, HCM-SCD, will be to evaluate CMR for risk stratification in hypertrophic cardiomyopathy(HCM).
- This registry is sought to collect data on the general use of CMR in the European clinical practice, its safety and its therapeutic implications in a high number of cases to 1) substantiate the clinical yield of CMR and 2) to define additional clinical questions worth to be investigated in detail as additional specific protocols in the future.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients undergoing CMR (enrolled into the "European clinical practice"-part of the registry Consecutive patients with suspected coronary artery disease or with hypertrophic cardiomyopathy (enrolled into the specific protocols "suspected-CAD" or "HCM-SCD").
Key inclusion criteria (3 listed)
- European clinical practice: Consecutive patients with accomplished CMR.
- -Suspected-CAD: Consecutive patients with suspected coronary artery disease undergoing a combined CMR protocol including evaluation of LV function, assessment of myocardial ische¬mia by adenosine stress perfusion or high-dose dobutamine CMR and detection of myocardial infarction using contrast-enhanced CMR.
- HCM-SCD: Consecutive patients with hypertrophic cardiomyopathy undergoing a combined CMR protocol including LV function, rest perfusion, and detection of myocardial scarring by contrast-enhanced CMR. The diagnosis of hypertrophic cardiomyopathy is based on the demonstration of a hypertrophied, non-dilated left ventricle (wall thickness of at least 15 mm in adults or the equivalent relative to body-surface area in children) in the absence of another cardiac or systemic disease capable of producing a similar degree of hypertrophy. In adult relatives of the patients with hypertrophic cardiomyo¬pathy, a wall thickness of 13 mm or more will be considered a criterion for diagnosis.
Key exclusion criteria (3 listed)
- European clinical practice: None
- Suspected-CAD: Missing informed consent. Patients with known CAD by invasive coronary angiography or previous MI.
- HCM-SCD: Missing informed consent. Patients with known CAD by invasive coronary angiography or previous MI. Patients with left ventricular hypertrophy of other causes (e.g. hypertension, valvular heart disease)
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
collect data from a large number of patients regarding the general use of CMR in European clinical practice, its safety and its therapeutic implications
Time frame: 01/01/2009-
2 secondary outcomes
to show that a normal CMR protocol (incl. LV wall motion at rest, stress ischemia, and scar detection) predicts a low risk of future cardiovascular events.
Time frame: 01/01/2009
to evaluate if myocardial scarring assessed by contrast-enhanced CMR is a stronger predictor of adverse events during follow up than the general clinical markers of an adverse long term outcome in HCM.
Time frame: 01/01/2009-
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 7 Sep 2016.
- Background: PubMed 20461126Bruder O, Wagner A, Mahrholdt H. Lessons Learned from the European Cardiovascular Magnetic Resonance (EuroCMR) Registry Pilot Phase. Curr Cardiovasc Imaging Rep. 2010 Jun;3(3):171-174. doi: 10.1007/s12410-010-9016-x. Epub 2010 Apr 13.
- Background: PubMed 19891768Wagner A, Bruder O, Schneider S, Nothnagel D, Buser P, Pons-Lado G, Dill T, Hombach V, Lombardi M, van Rossum AC, Schwitter J, Senges J, Sabin GV, Sechtem U, Mahrholdt H, Nagel E. Current variables, definitions and endpoints of the European cardiovascular magnetic resonance registry. J Cardiovasc Magn Reson. 2009 Nov 5;11(1):43. doi: 10.1186/1532-429X-11-43.
- Background: PubMed 19682818Bruder O, Schneider S, Nothnagel D, Dill T, Hombach V, Schulz-Menger J, Nagel E, Lombardi M, van Rossum AC, Wagner A, Schwitter J, Senges J, Sabin GV, Sechtem U, Mahrholdt H. EuroCMR (European Cardiovascular Magnetic Resonance) registry: results of the German pilot phase. J Am Coll Cardiol. 2009 Oct 6;54(15):1457-66. doi: 10.1016/j.jacc.2009.07.003. Epub 2009 Aug 13.
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.
Heiko Mahrholdt, MD principal investigator
Robert-Bosch-Medical-Center, Stuttgart, Germany
Oliver Bruder, MD principal investigator
Elisabeth-Hospital, Essen, Germany
10 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Consecutive Patients Undergoing CMR, run by Stiftung Institut fuer Herzinfarktforschung at 10 sites in 4 countries.
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 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 7 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Germany, Italy, Spain, Switzerland. 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?
collect data from a large number of patients regarding the general use of CMR in European clinical practice, its safety and its therapeutic implications (time frame: 01/01/2009-). 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 NCT01197677, which also lists 3 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 7 Sep 2016.