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


- candidate number11280
- NTR NumberNTR3331
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR5-mrt-2012
- Secondary IDs11.10115 METC
- Public TitleProspective Assessment of Risk Factors for Appropriate ICD Intervention in Patients with Ischemic Cardiomyopathy.
- Scientific TitleProspective Assessment of Risk Factors for Appropriate ICD Intervention in Patients with Ischemic Cardiomyopathy.
- ACRONYMPARCADIA
- hypothesisThe 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.
- Healt Condition(s) or Problem(s) studiedIschemic cardiomypathy, Heart failure
- Inclusion criteria1. Patient with ischemic cardiomyopathy indicated for a de novo ICD implantation for primary prevention, according to ESC guidelines or local standards (MADIT II population);
2. Written informed consent / willingness and ability to comply with the protocol.
- Exclusion criteria1. Contraindication for MRI;
2. Severe renal dysfunction (stage 4 or 5) resulting in contra-indication for the admission of gadolinium during MRI;
3. Indication for secondary prevention ICD implantation;
4. Class I indication for cardiac resynchronization therapy;
5. Heart failure with New York Heart Association functional class IV;
6. LV ejection fraction >40%;
7. Age <18 years and >85 years;
8. Women that are pregnant, lactating or planning to become pregnant;
9. Participating in any other clinical trial with active intervention(s) during the course of this study;
10. Life expectancy less than 1 year.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 16-apr-2012
- planned closingdate16-apr-2019
- Target number of participants200
- InterventionsICD implantation. Patients are alreay planned for ICD. So they will also receive an ICD when they are not participating in the study.
- Primary outcomeThe primary objective of the clinical investigation is to determine whether there is a relationship between appropriate ICD intervention (shock or ATP) and the Relative Infarct Transmurality (RIT) obtained from Late Gadolinium Enhanced Cardiac Magnetic Resonance (LGE-CMR) imaging in patients with ischemic cardiomyopathy, receiving an ICD for primary prevention (MADIT II population).
- Secondary outcomeThe secondary objectives of the clinical investigation are to identify baseline risk factors for appropriate ICD intervention determined before ICD implantation and to provide sufficient clinical data for a future confirmatory clinical investigation:
1. Identify a RIT cut-off value as a baseline risk factor that can predict appropriate ICD intervention;
2. Identify other baseline risk factors that can predict appropriate ICD intervention;
3. Design a risk score system, based on risk factors in Coumel categories including trigger (PVC/hr), modulation (HRV) and substrate (RIT).
- TimepointsPatients will be seen by the investigator at the enrolment visit, pre implant screening, ICD implantation, pre-hospital discharge visit, and follow-up (FUP) visits at 2, 6, 12, 18, 24 months including home monitoring. Additional routine FUP every 6 months until study termination after last enrolled patient has completed 2 years FUP.
- Trial web sitewww.diagram-zwolle.nl
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Mark Ver Heyen
- CONTACT for SCIENTIFIC QUERIESDr. A. Elvan
- Sponsor/Initiator BIOTRONIK SE & Co. KG
- Funding
(Source(s) of Monetary or Material Support)
BIOTRONIK SE & Co. KG
- PublicationsN/A
- Brief summaryIn the present clinical investigation, we will perform an analysis of baseline risk factors to identify predictors for appropriate ICD intervention in patients with ischemic cardiomyopathy receiving an ICD for primary prevention. The study will be performed in centres in The Netherlands.
- Main changes (audit trail)
- RECORD5-mrt-2012 - 23-mei-2016


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