Clinical trial NCT01197677: European CMR Registry
Official title: European Cardiovascular Magnetic Resonance Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Consecutive Patients Undergoing CMR
Keywords: CMR
Register
CAD
myocard scarring
Lead sponsor: Stiftung Institut fuer Herzinfarktforschung
Sponsor class: OTHER
First posted: 2010-09-09
Enrollment: 30000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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").

Brief 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. 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).
3. 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.


Eligibility criteria: Inclusion Criteria:

- 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.

Exclusion Criteria:

* 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)

Primary outcomes:
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
timeFrame: 01/01/2009-
Secondary outcomes:
measure: 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.
timeFrame: 01/01/2009
measure: 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.
timeFrame: 01/01/2009-
Other outcomes:
Locations:
city: Coburg
country: Germany
facility: Klinikum Coburg
city: Essen
country: Germany
facility: Elisabeth Krankenhaus
city: Frankfurt
country: Germany
facility: Cardioangiologisches Centrum Bethanien
city: Hausham
country: Germany
facility: Krankenhaus Agatharied
city: Ludwigsburg
country: Germany
facility: Klinikum Ludwigsburg-Bietigheim
city: Stuttgart
country: Germany
facility: Robert Bosch Medical Centre
city: Traunstein
country: Germany
facility: Klinikum Traunstein
city: Pisa
country: Italy
facility: Clinical Physiology Institute
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois
Study officials:
affiliation: Robert-Bosch-Medical-Center, Stuttgart, Germany
name: Heiko Mahrholdt, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Elisabeth-Hospital, Essen, Germany
name: Oliver Bruder, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Wagner 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.
citation: Bruder 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.