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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
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 February 27, 2015