European CMR Registry

NCT ID: NCT01197677

Last Updated: 2016-09-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-04-30

Study Completion Date

2013-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Consecutive Patients Undergoing CMR

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stiftung Institut fuer Herzinfarktforschung

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Heiko Mahrholdt, MD

Role: PRINCIPAL_INVESTIGATOR

Robert-Bosch-Medical-Center, Stuttgart, Germany

Oliver Bruder, MD

Role: PRINCIPAL_INVESTIGATOR

Elisabeth-Hospital, Essen, Germany

Locations

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Klinikum Coburg

Coburg, , Germany

Site Status

Elisabeth Krankenhaus

Essen, , Germany

Site Status

Cardioangiologisches Centrum Bethanien

Frankfurt, , Germany

Site Status

Krankenhaus Agatharied

Hausham, , Germany

Site Status

Klinikum Ludwigsburg-Bietigheim

Ludwigsburg, , Germany

Site Status

Robert Bosch Medical Centre

Stuttgart, , Germany

Site Status

Klinikum Traunstein

Traunstein, , Germany

Site Status

Clinical Physiology Institute

Pisa, , Italy

Site Status

Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

Site Status

Centre Hospitalier Universitaire Vaudois

Lausanne, , Switzerland

Site Status

Countries

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Germany Italy Spain Switzerland

References

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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.

Reference Type BACKGROUND
PMID: 20461126 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19891768 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19682818 (View on PubMed)

Other Identifiers

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Euro CMR

Identifier Type: -

Identifier Source: org_study_id

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