Long-term Evaluation of Patients Receiving Bone Marrow-derived Cell Administration for Heart Disease
This trial is active, not recruiting.
|Conditions||acute myocardial infarction, ischemic cardiomyopathy, dilated cardiomyopathy, heart failure|
|Treatment||autologous bone marrow-derived cells|
|Sponsor||Johann Wolfgang Goethe University Hospital|
|Start date||October 2001|
|End date||December 2017|
|Trial size||1500 participants|
|Trial identifier||NCT00962364, 201-01-BMC-Reg|
This study will provide follow-up information and care of patients who have undergone autologous intracoronary bone marrow cell administration at our institution. Patients are monitored for their response to treatment, progression of heart failure and coronary artery disease, and potential later occurring effects of the administered bone marrow cells.
Patients are eligible for this follow-up study if they have received their first intracoronary bone marrow cell administration for the treatment of cardiac disease at our institution from 2001 ongoing.
Participants are generally seen in the clinic at 12 months and 5 years after cell administration, in the meantime regular yearly telephone contacts are performed until 10 years after cell transplantation.
The detailed description contains the planned procedures that are performed during the clinical visits and, if necessary, at additional contacts.
Evaluation of procedural and long-term safety of intracoronary administration of bone marrow cells for the treatment for cardiac disease
time frame: 10 years
Male or female participants at least 18 years old.
Inclusion Criteria: Clinical diagnosis of heart disease with signs and symptoms of heart failure due to - acute myocardial infarction or - ischemic cardiomyopathy with or without previous myocardial infarction or - dilated cardiomyopathy due to valvular heart disease, hypertensive heart disease, history of myocarditis (no active myocardial infection present) Exclusion Criteria: - none, all patients meeting the inclusion criteria will be eligible.
|Official title||Long-term Evaluation and Follow-up Care of Patients Receiving Intracoronary Bone Marrow-derived Cell Administration for Heart Disease|
|Principal investigator||Andreas M Zeiher, Prof. Dr|
|Description||In detail, the following procedures are performed during the clinical visits and, if necessary, at additional contacts: - periodic physical examination and blood tests - non-invasive imaging studies may include echocardiography and magnetic resonance imaging - electrocardiogram at rest and during treadmill testing (may include spiroergometry testing) - interrogation of implanted defibrillators / pacemakers for monitoring of arrhythmias|
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