Status:
COMPLETED
Cell-Wave Study: Combined Extracorporal Shock Wave Therapy and Intracoronary Cell Therapy in Chronic Ischemic Myocardium
Lead Sponsor:
Johann Wolfgang Goethe University Hospital
Conditions:
Congestive Heart Failure
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
Brief Summary
Extracorporal shock wave therapy is performed prior to cell therapy for induction of therapeutic neovascularization and improvement of homing of bone marrow progenitor cells in patients with chronic i...
Detailed Description
Single center, Phase I-II Study (Safety, Feasibility and Efficacy) Double-blind, randomised trial (Cell therapy), single blind (Shockwave)
Eligibility Criteria
Inclusion
- Patients with chronic ischemic heart disease
- Patients with anterior myocardial infarction \> 3months
- EF \< 50% or NYHA II-IV
- Age 18-80
- Informed consent
Exclusion
- Ventricular thrombus
- Infarct \< 3 months.
- Active infection or fever
- Chronic inflammatory disease (e.g M. Crohn, Rheumatoid Arthritis)
- HIV Infection oder active Hepatitis
- Neoplastic disease w/o complete remission within 5 years
- Stroke \< 3months
- Creatinine \> 2 mg/dl
- Relevant Liver disease (GOT \> twice the upper limit).
- Anemia (Hemoglobin \<10 mg/dl)
- Thrombocytopenia \< 100.000/µl
- Allergies to Aspirin, Clopidogrel, Heparin
- History of bleeding disorder
- History of coagulopathy
- Gastrointestinal Bleeding \< 3 months
- Surgery or Trauma \< 2 months
- Pregnancy
- Mental Retardation
- Participation in other clinical study \< 1 month
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT00326989
Start Date
May 1 2006
End Date
December 1 2011
Last Update
March 21 2017
Active Locations (1)
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1
Div. of Cardiology , University of Frankfurt
Frankfurt, Germany, 60590