Brief Title
Long-term Evaluation of Patients Receiving Bone Marrow-derived Cell Administration for Heart Disease
Official Title
Long-term Evaluation and Follow-up Care of Patients Receiving Intracoronary Bone Marrow-derived Cell Administration for Heart Disease
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
Study Type
Observational
Primary Outcome
Evaluation of procedural and long-term safety of intracoronary administration of bone marrow cells for the treatment for cardiac disease
Condition
Acute Myocardial Infarction
Intervention
autologous bone marrow-derived cells
Study Arms / Comparison Groups
AMI
Description: Patients with acute myocardial infarction treated with intracoronary administration of bone marrow derived cells
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
1500
Start Date
October 2001
Completion Date
December 2021
Primary Completion Date
December 2020
Eligibility Criteria
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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Andreas M Zeiher, Prof. Dr, ,
Location Countries
Germany
Location Countries
Germany
Administrative Informations
NCT ID
NCT00962364
Organization ID
201-01-BMC-Reg
Responsible Party
Principal Investigator
Study Sponsor
Johann Wolfgang Goethe University Hospital
Study Sponsor
Andreas M Zeiher, Prof. Dr, Principal Investigator, Cardiology, Goethe University Frankfurt, Germany
Verification Date
February 2020