European CMR Registry

NCT01197677 | Completed

• 1 other identifier: Euro CMR
• Study Type: observational
• Target: 30,000
• Locations: 4 countries
• Sites: 10

Brief Summary

1. 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. 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. 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.

Conditions

Consecutive Patients Undergoing CMR

Keywords

CMR; Register; CAD; myocard scarring

Outcome Measures

Primary Outcomes (1)

• collect data from a large number of patients regarding the general use of CMR in European clinical practice, its safety and its therapeutic implications

  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.

  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.

  01/01/2009-

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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").

You may qualify if:

• \- 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Stiftung Institut fuer Herzinfarktforschung: lead

Study Sites (10)

Klinikum Coburg

Coburg, 96450, Germany

Location

Elisabeth Krankenhaus

Essen, 45138, Germany

Location

Cardioangiologisches Centrum Bethanien

Frankfurt, 60389, Germany

Location

Krankenhaus Agatharied

Hausham, 83734, Germany

Location

Klinikum Ludwigsburg-Bietigheim

Ludwigsburg, 71640, Germany

Location

Robert Bosch Medical Centre

Stuttgart, 70376, Germany

Location

Klinikum Traunstein

Traunstein, 83278, Germany

Location

Clinical Physiology Institute

Pisa, 56010, Italy

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

Location

Centre Hospitalier Universitaire Vaudois

Lausanne, CH-1011, Switzerland

Location

Related Publications (3)

• 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.

  PMID: 20461126 BACKGROUND

• 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.

  PMID: 19891768 BACKGROUND

• 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.

  PMID: 19682818 BACKGROUND

Study Officials

• Heiko Mahrholdt, MD

  Robert-Bosch-Medical-Center, Stuttgart, Germany

  PRINCIPAL INVESTIGATOR

• Oliver Bruder, MD

  Elisabeth-Hospital, Essen, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2010
• First Posted: September 9, 2010
• Study Start: April 1, 2009
• Primary Completion: September 1, 2009
• Study Completion: October 1, 2013
• Last Updated: September 7, 2016

Record last verified: 2016-09

Locations

CH (1); ES (1); IT (1); DE (7)