European CMR Registry

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Stiftung Institut fuer Herzinfarktforschung.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Stiftung Institut fuer Herzinfarktforschung
ClinicalTrials.gov Identifier:
NCT01197677
First received: September 7, 2010
Last updated: NA
Last verified: September 2010
History: No changes posted
  Purpose
  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.

Condition
Consecutive Patients Undergoing CMR

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: European Cardiovascular Magnetic Resonance Registry

Resource links provided by NLM:


Further study details as provided by Stiftung Institut fuer Herzinfarktforschung:

Primary Outcome Measures:
  • 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- ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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- ] [ Designated as safety issue: No ]

Estimated Enrollment: 20000
Study Start Date: April 2009
Estimated Study Completion Date: April 2012
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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").

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01197677

Locations
Germany
Klinikum Coburg
Coburg, Germany, 96450
Elisabeth Krankenhaus
Essen, Germany, 45138
Cardioangiologisches Centrum Bethanien
Frankfurt, Germany, 60389
Krankenhaus Agatharied
Hausham, Germany, 83734
Klinikum Ludwigsburg-Bietigheim
Ludwigsburg, Germany, 71640
Robert Bosch Medical Centre
Stuttgart, Germany, 70376
Klinikum Traunstein
Traunstein, Germany, 83278
Italy
Clinical Physiology Institute
Pisa, Italy, 56010
Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08025
Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland, CH-1011
Sponsors and Collaborators
Stiftung Institut fuer Herzinfarktforschung
Investigators
Principal Investigator: Heiko Mahrholdt, MD Robert-Bosch-Medical-Center, Stuttgart, Germany
Principal Investigator: Oliver Bruder, MD Elisabeth-Hospital, Essen, Germany