Overview

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

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Arm
Patients with acute myocardial infarction treated with intracoronary administration of bone marrow derived cells
autologous bone marrow-derived cells
autologous bone marrow-derived cells isolated by density gradient centrifugation from 50 ml bone marrow aspirate obtained under local anesthesia
Patients with ischemic cardiomyopathy treated with intracoronary administration of bone marrow derived cells
autologous bone marrow-derived cells
autologous bone marrow-derived cells isolated by density gradient centrifugation from 50 ml bone marrow aspirate obtained under local anesthesia
Patients with dilated cardiomyopathy treated with intracoronary administration of bone marrow derived cells
autologous bone marrow-derived cells
autologous bone marrow-derived cells isolated by density gradient centrifugation from 50 ml bone marrow aspirate obtained under local anesthesia

Primary Outcomes

Measure
Evaluation of procedural and long-term safety of intracoronary administration of bone marrow cells for the treatment for cardiac disease
time frame: 10 years

Eligibility Criteria

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.

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Johann Wolfgang Goethe University Hospital.