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
  Purpose

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


Condition Intervention Phase
Congestive Heart Failure
Procedure: intracoronary stem cell therapy
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Extracorporal Shock Wave Therapy for Induction of Therapeutic Neovascularization and Homing of Bone Marrow Progenitor Cells in Patients With Chronic Ischemic Heart Disease

Resource links provided by NLM:


Further study details as provided by Johann Wolfgang Goethe University Hospitals:

Primary Outcome Measures:
  • Improvement in global ejection fraction on LV angiography [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 103
Study Start Date: May 2006
Study Completion Date: November 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Low-dose shock wave treatment & Placebo Procedure: intracoronary stem cell therapy
extracorporal shock waves prior to intracoronary cell therapy
Active Comparator: low-dose shock-wave treatment & Cell therapy Procedure: intracoronary stem cell therapy
extracorporal shock waves prior to intracoronary cell therapy
Active Comparator: High-dose shock-wave treatment & Placebo Procedure: intracoronary stem cell therapy
extracorporal shock waves prior to intracoronary cell therapy
Active Comparator: High-dose shock-wave treatment & cell therapy Procedure: intracoronary stem cell therapy
extracorporal shock waves prior to intracoronary cell therapy
Active Comparator: Placebo shock-wave treatment & cell therapy Procedure: intracoronary stem cell therapy
extracorporal shock waves prior to intracoronary cell therapy

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00326989

Locations
Germany
Div. of Cardiology , University of Frankfurt
Frankfurt, Germany, 60590
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospitals
Investigators
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
  More Information

No publications provided by Johann Wolfgang Goethe University Hospitals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: A. M. Zeiher, Prof. Dr. Andreas M. Zeiher, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier: NCT00326989     History of Changes
Other Study ID Numbers: 2005-005709-50, Cellwave CHF
Study First Received: May 16, 2006
Last Updated: September 19, 2012
Health Authority: Germany: Paul-Ehrlich-Institut
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Johann Wolfgang Goethe University Hospitals:
Extracorporal shock wave therapy
Cell therapy

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on October 30, 2014