Elimination of Microemboli During Aortic Valve Replacement (ELMAR)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by University of Giessen.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
University of Giessen
Collaborator:
Else Kröner Fresenius Foundation
Information provided by:
University of Giessen
ClinicalTrials.gov Identifier:
NCT01128751
First received: May 18, 2010
Last updated: May 21, 2010
Last verified: May 2010
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
In a randomized controlled trial patients undergoing aortic valve replacement are recruited into 3 groups. Patients receive either an intra-aortic filter (Embol-X), designed to reduce solid microemboli during mechanical surgical intervention, a dynamic bubble-trap (DBT), designed to reduce gaseous microemboli from cardiopulmonary bypass (CPB), or no additional device (control-group). Cognitive functioning is assessed 3 weeks to 1 day before and 3 months (+/- 1 week) after valve replacement. Furthermore, cerebral magnetic resonance imaging (MRI) is carried 2-6 days after surgery. Primary endpoint is the cognitive outcome of the filter groups compared to the controls. Secondary endpoint is the number of acute ischemic lesions after CABG.
| Condition | Intervention |
|---|---|
|
Neurocognitive Outcome After Aortic Valve Replacement |
Procedure: Embol-X intra-aortic emboli filter Procedure: DBT dynamic bubble trap Procedure: Control group |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | ELMAR - Elimination of Microemboli During Aortic Valve Replacement. A Randomized Controlled Trial |
Further study details as provided by University of Giessen:
Primary Outcome Measures:
- Neuropsychological assessment 1 [ Time Frame: 3 weeks to 1 day before intervention ] [ Designated as safety issue: Yes ]Patients are assessed by an extensive neuropsychological test battery to test cognitive functions and psychological measures
- Neuropsychological assessment 2 [ Time Frame: 3 months (+/- 1 week) post intervention ] [ Designated as safety issue: Yes ]Patients are assessed by an extensive neuropsychological test battery to test cognitive functions and psychological measures
Secondary Outcome Measures:
- MRI lesions detected after surgery [ Time Frame: 2-6 days postoperative ] [ Designated as safety issue: Yes ]In MRI micro-embolic lesions are detected using diffusion weighted imaging (DWI)
| Estimated Enrollment: | 150 |
| Study Start Date: | March 2010 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Embol-X
Patients in this arm receive intra-aortic filter designed to catch solid debris for neuroprotection during surgery.
|
Procedure: Embol-X intra-aortic emboli filter
Patients in this arm receive intra-aortic filter designed to catch solid debris for neuroprotection during surgery.
|
|
Active Comparator: DBT dynamic bubble trap
Patients in this arm receive a dynamic bubble trap to reduce gaseous micro-emboli from cardiopulmonary bypass for neuroprotection during surgery
|
Procedure: DBT dynamic bubble trap
Patients in this arm receive a dynamic bubble trap to reduce gaseous micro-emboli from cardiopulmonary bypass for neuroprotection during surgery
|
|
No Intervention: Control group
In comparison to arm 1 and 2, patients in this arm do not receive an additional intervention during surgery
|
Procedure: Control group
In comparison to arm 1 and 2, patients in this arm do not receive an additional intervention during surgery
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age > 18
- Elective aortic valve replacement
- Informed consent
- German language
Exclusion Criteria:
- Neurological and psychiatric diseases that would conflict with neuropsychological testing (e.g. stroke, TBI, schizophrenia, etc.); further major surgeries on CPB planned for within 3 months after valve replacement
- Contraindication against MRI assessment
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01128751
Contacts
| Contact: Niko Schwarz, PhD | +49(0)6032/999- ext 5811 | niko.schwarz@neuro.med.uni-giessen.de |
| Contact: Tibo Gerriets, MD | +40(0)6032/999- ext 5812 | tibo.gerriets@neuro.med.uni-giessen.de |
Locations
| Germany | |
| University Clinic Giessen | Recruiting |
| 35392 Giessen, Hessen, Germany, 35392 | |
| Sub-Investigator: Jörn Bohn | |
| Johann Wolfgang Goehte University Clinic | Recruiting |
| 60590 Frankfurt, Hessen, Germany, 60590 | |
| Sub-Investigator: Annika Löffler | |
| Kerckhoff Clinic | Recruiting |
| 61231 Bad Nauheim, Hessen, Germany, 61231 | |
| Principal Investigator: Niko Schwarz, PhD | |
Sponsors and Collaborators
University of Giessen
Else Kröner Fresenius Foundation
More Information
No publications provided
| Responsible Party: | PD Dr. Tibo Gerriets, Justus Liebig University, Department of Neurology |
| ClinicalTrials.gov Identifier: | NCT01128751 History of Changes |
| Other Study ID Numbers: | P41/09// A67/09 |
| Study First Received: | May 18, 2010 |
| Last Updated: | May 21, 2010 |
| Health Authority: | Germany: Ethics Commission |
Keywords provided by University of Giessen:
|
Cognition Neuroprotection Cardiopulmonary bypass Aortic valve replacement Micro-emboli |
ClinicalTrials.gov processed this record on May 23, 2013