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NCT Number: NCT00326989

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

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

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Key information

Conditions

Congestive Heart Failure Cardiovascular Diseases Heart Diseases Heart Failure

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Div. of Cardiology , University of Frankfurt

Frankfurt, 60590, Germany

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

intracoronary stem cell therapy

Procedure

extracorporal shock waves prior to intracoronary cell therapy

Primary outcomes

  1. Improvement in global ejection fraction on LV angiography

    Time frame: 4 months

Secondary outcomes

  1. Global or regional wall motion at 4 months and 1 year

    Time frame: 4 months

  2. NYHA Class

    Time frame: 4 months

  3. NT BNP levels

    Time frame: 4 months

  4. MACE

    Time frame: 4 months

  5. Life quality

    Time frame: 4 months

Sponsors and collaborators

Lead sponsor

Johann Wolfgang Goethe University Hospital

Other

Registry information

Official study title

Extracorporal Shock Wave Therapy for Induction of Therapeutic Neovascularization and Homing of Bone Marrow Progenitor Cells in Patients With Chronic Ischemic Heart Disease

Important dates

Study start
2006
Primary completion
2011
Study completion
2011
First posted
May 17, 2006
Registry last updated
Mar 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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