European CMR Registry

European Cardiovascular Magnetic Resonance Registry

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01197677

Enrollment

30000

Registered

2010-09-09

Start date

2009-04-30

Completion date

2013-10-31

Last updated

2016-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Consecutive Patients Undergoing CMR

Keywords

CMR, Register, CAD, myocard scarring

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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-

Countries

Germany, Italy, Spain, Switzerland

Outcome results