Prospective Assessment of Risk Factors for Appropriate ICD Intervention in Patients with Ischemic Cardiomyopathy .

Completed

Conditions: disease of the heart muscle
ischemische cardiomyopathy
10019280

Registration Number: NL-OMON40036

Lead Sponsor: Biotronik

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 200

Inclusion Criteria

*Patient with ischemic cardiomyopathy with an indication for de novo ICD implantation for primary prevention, according to ESC guidelines or local standards (MADIT II population)
*Written informed consent / willingness and ability to comply with the protocol

Exclusion Criteria

*Contraindication for MRI
*Severe renal dysfunction (if leading to a contraindication for the admission of Gadolinium with MRI)
*Indication for secondary prevention ICD implantation
*Class I indication for CRT-D
*Heart failure with New York Heart Association functional class IV
*LV ejection fraction >40%
*Age <18 years and >85 years
*Women that are pregnant, lactating or planning to become pregnant
*Participating in any other clinical trial with active intervention(s) during the course of this clinical investigation
*Life expectancy less than 1 year

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>* % Relative infarct transmurity measured by LGE-CMR (Late Gadolinium Enhanced<br /><br>Cardiac Magnetic Resonance )<br /><br>*Appropriate ICD intervention (shock and/or ATP)<br /><br><br /><br>The primary alternative hypothesis states that the mean relative infarct<br /><br>transmurality (RIT) is different in patients with (RITshock or ATP ) and<br /><br>without appropriate ICD intervention, i.e. shock or ATP.<br /><br><br /><br>· Null hypothesis H0: RITshock or<br /><br>ATP = RITno shock or ATP<br /><br><br /><br>· Alternative hypothesis HA: RITshock or ATP¹<br /><br>RITno shock or AT<br /><br><br /><br></p><br>

Secondary Outcome Measures

Name	Time	Method
<p>It is expected that appropriate ICD Intervention can be predicted by RIT and<br /><br>other baseline risk markers determined before ICD implantation. Because of a<br /><br>lack of clinical data, hypotheses cannot be pre-specified in a confirmatory<br /><br>setting. Thus, the data will be analyzed in an exploratory setting to generate<br /><br>hypotheses for a future confirmatory clinical investigation<br /><br><br /><br></p><br>