Long-term Evaluation of Patients Receiving Bone Marrow-derived Cell Administration for Heart Disease

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 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

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