Clinical trial NCT00326989: Cell-Wave Study: Combined Extracorporal Shock Wave Therapy and Intracoronary Cell Therapy in Chronic Ischemic Myocardium
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Congestive Heart Failure
Keywords: Extracorporal shock wave therapy
Cell therapy
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
First posted: 2006-05-17
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

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

Eligibility 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

Primary outcomes:
measure: Improvement in global ejection fraction on LV angiography
timeFrame: 4 months
Secondary outcomes:
measure: Global or regional wall motion at 4 months and 1 year
timeFrame: 4 months
measure: NYHA Class
timeFrame: 4 months
measure: NT BNP levels
timeFrame: 4 months
measure: MACE
timeFrame: 4 months
measure: Life quality
timeFrame: 4 months
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: Div. of Cardiology , University of Frankfurt
Study officials:
affiliation: Div. of Cardiology, University of Frankfurt, Germany
name: Andreas M Zeiher, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Div. of Cardiology, University of Frankfurt
name: Dirk H Walter, MD
role: STUDY_DIRECTOR
References:
citation: Assmus B, Walter DH, Seeger FH, Leistner DM, Steiner J, Ziegler I, Lutz A, Khaled W, Klotsche J, Tonn T, Dimmeler S, Zeiher AM. Effect of shock wave-facilitated intracoronary cell therapy on LVEF in patients with chronic heart failure: the CELLWAVE randomized clinical trial. JAMA. 2013 Apr 17;309(15):1622-31. doi: 10.1001/jama.2013.3527.
citation: Leistner DM, Seeger FH, Fischer A, Roxe T, Klotsche J, Iekushi K, Seeger T, Assmus B, Honold J, Karakas M, Badenhoop K, Frantz S, Dimmeler S, Zeiher AM. Elevated levels of the mediator of catabolic bone remodeling RANKL in the bone marrow environment link chronic heart failure with osteoporosis. Circ Heart Fail. 2012 Nov;5(6):769-77. doi: 10.1161/CIRCHEARTFAILURE.111.966093. Epub 2012 Aug 30.