Bone Marrow Derived Mononuclear Cells for Ischemic Cardiomyopathy (Alster-Star)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Asklepios proresearch.
Recruitment status was Recruiting
Information provided by:
First received: June 14, 2010
Last updated: August 10, 2012
Last verified: August 2012
This is an evaluative, monocentric study in patients with chronic ischemic heart disease and left bundle branch block who received an ICD-CRT. It is an early investigation on the safety and effects of a single administration of bone marrow derived mononuclear cells after implantation of an ICD-CRT device as an adjunct to CRT and usual drug treatment.
Procedure: Intramyocardial Cell therapy
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Protocol on an Evaluative Study on Bone Marrow Derived Mononuclear Cells for Optimization of Biventricular Pacing in Patients With Chronic Ischemic Left Ventricular Dysfunction
Primary Outcome Measures:
| Estimated Enrollment:
| Study Start Date:
| Estimated Primary Completion Date:
||May 2013 (Final data collection date for primary outcome measure)
Procedure: Intramyocardial Cell therapy
Intramyocardial Cell therapy in patients with chronic ischemic heart disease after ICD CRT Implantation
|Ages Eligible for Study:
||18 Years to 80 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- chronic left ventricular dysfunction (ejection fraction <35 %) in chronic ischemic heart disease and asynchronic contraction with indication for a biventricular stimulation (CRT, chronic resynchronization therapy), who do not have an improvement of >15% of LVEF 3 months after CRT-device implantation
- wall motion dysfunction of any territory
- left bundle branch block
- Patients were on individual optimal treatment for chronic ischemic heart disease with one or a combination of the following drug types: diuretics, ß-blockers, ACE-inhibitors, AT1 blockers and/or lipid lowering agents for at least 30 days before CRT Implantation
- patients with left ventricular dysfunction due to other reasons than ischemic cardiomyopathy, e.g. hypertension, dilatative cardiomyopathy
- with relevant valvular disease;
- Aneurysma of the anterior myocardial wall or myocardial wall thickness of < 5 mm,
- with overt heart failure, other than ischemic cardiomyopathy,
- with history of stroke and/or transient ischemic attack (TIA),
- with history of thromboembolic event (e.g. phlebothrombosis, pulmonary embolism), bleeding disorders and known disease of the coagulation system;
- with extensive deviations of baseline laboratory values and significant findings at physical examination which in the opinion of the investigator may worsen under treatment;
- with severe systemic disease - (e.g. known or suspected anaphylaxia, intolerance against X-ray or contrast agent and, pre-malignant and malignant disease)
- atrial fibrillation with average heart rate >70 bpm
- pregnant women and women of childbearing potential who have not had a negative pregnancy test within 48 hours before treatment;
- with any disease or condition that seriously compromises the function of other body systems than the heart and/or might interfere with conduct of the study and interpretation of the results;
- patients with a chronic or acute HIV-, HBV-, HCV-infection;
- improvement of more than 15% of LVEF 3 months after CRT-device implantation
- patients who have a ICD Implantation for secondary prophylactic indication. These patients show a history of resuscitation, VT or syncope.
- patients who are currently participating in another investigational drug or device study
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01144221
|Asklepios Clinic St. Georg
|Hamburg, Germany, 20099 |
|Contact: Korff Krause, Dr. med. 0049-40-181885 ext 4493 |
|Principal Investigator: Korff Krause, Dr. med. |
||Korff Krause, Dr. med.
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||June 14, 2010
||August 10, 2012
Keywords provided by Asklepios proresearch:
Chronic Ischemic Heart Disease
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 16, 2014