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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON40036

Enrollment

200

Registered

2012-03-20

Start date

2012-07-26

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

disease of the heart muscle ischemische cardiomyopathy

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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 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

Design outcomes

Primary

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

Measure

Time frame

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

—

Secondary

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

Countries

Netherlands

Outcome results