Acute Myocardial Infarction, Dilated Cardiomyopathy, Heart Failure, Ischemic Cardiomyopathy
Conditions
Brief summary
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.
Detailed 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
Interventions
autologous bone marrow-derived cells isolated by density gradient centrifugation from 50 ml bone marrow aspirate obtained under local anesthesia
Sponsors
Study design
Eligibility
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of procedural and long-term safety of intracoronary administration of bone marrow cells for the treatment for cardiac disease | 10 years |
Countries
Germany