Cell-Wave Study: Combined Extracorporal Shock Wave Therapy and Intracoronary Cell Therapy in Chronic Ischemic Myocardium

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
A. M. Zeiher, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT00326989
First received: May 16, 2006
Last updated: September 19, 2012
Last verified: September 2012

May 16, 2006
September 19, 2012
May 2006
September 2011   (final data collection date for primary outcome measure)
Improvement in global ejection fraction on LV angiography [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Improvement in global ejection fraction on LV angiography
Complete list of historical versions of study NCT00326989 on ClinicalTrials.gov Archive Site
  • Global or regional wall motion at 4 months and 1 year [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • NYHA Class [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • NT BNP levels [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • MACE [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
  • Life quality [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Global or regional wall motion at 4 months and 1 year
  • NYHA Class
  • NT BNP levels
  • MACE
  • Life quality
Not Provided
Not Provided
 
Cell-Wave Study: Combined Extracorporal Shock Wave Therapy and Intracoronary Cell Therapy in Chronic Ischemic Myocardium
Extracorporal Shock Wave Therapy for Induction of Therapeutic Neovascularization and Homing of Bone Marrow Progenitor Cells in Patients With Chronic Ischemic Heart Disease

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 ischemic heart disease following anterior myocardial infarction.

Shock waves can induce growth factor expression in the ischemic myocardium and might augment homing of autologous bone marrow mononuclear cells which are injected intracoronary 24 h following shock wave therapy

Single center, Phase I-II Study (Safety, Feasibility and Efficacy) Double-blind, randomised trial (Cell therapy), single blind (Shockwave)

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Congestive Heart Failure
Procedure: intracoronary stem cell therapy
extracorporal shock waves prior to intracoronary cell therapy
  • Active Comparator: Low-dose shock wave treatment & Placebo
    Intervention: Procedure: intracoronary stem cell therapy
  • Active Comparator: low-dose shock-wave treatment & Cell therapy
    Intervention: Procedure: intracoronary stem cell therapy
  • Active Comparator: High-dose shock-wave treatment & Placebo
    Intervention: Procedure: intracoronary stem cell therapy
  • Active Comparator: High-dose shock-wave treatment & cell therapy
    Intervention: Procedure: intracoronary stem cell therapy
  • Active Comparator: Placebo shock-wave treatment & cell therapy
    Intervention: Procedure: intracoronary stem cell therapy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
103
November 2011
September 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with chronic ischemic heart disease
  • Patients with anterior myocardial infarction > 3months
  • EF < 50% or NYHA II-IV
  • Age 18-80
  • Informed consent

Exclusion Criteria:

  • 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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00326989
2005-005709-50, Cellwave CHF
No
A. M. Zeiher, Johann Wolfgang Goethe University Hospitals
Johann Wolfgang Goethe University Hospitals
Not Provided
Principal Investigator: Andreas M Zeiher, MD Div. of Cardiology, University of Frankfurt, Germany
Study Director: Dirk H Walter, MD Div. of Cardiology, University of Frankfurt
Johann Wolfgang Goethe University Hospitals
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP