Back to resultsCell-Wave Study: Combined Extracorporal Shock Wave Therapy and Intracoronary Cell Therapy in Chronic Ischemic Myocardium
Primary Purpose
Congestive Heart Failure
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
intracoronary stem cell therapy
Sponsored by
About this trial
This is an interventional treatment trial for Congestive Heart Failure focused on measuring Extracorporal shock wave therapy, Cell therapy
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
Sites / Locations
- Div. of Cardiology , University of Frankfurt
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Low-dose shock wave treatment & Placebo
low-dose shock-wave treatment & Cell therapy
High-dose shock-wave treatment & Placebo
High-dose shock-wave treatment & cell therapy
Placebo shock-wave treatment & cell therapy
Arm Description
Outcomes
Primary Outcome Measures
Improvement in global ejection fraction on LV angiography
Secondary Outcome Measures
Global or regional wall motion at 4 months and 1 year
NYHA Class
NT BNP levels
MACE
Life quality
Full Information
NCT ID
NCT00326989
First Posted
May 16, 2006
Last Updated
March 20, 2017
Sponsor
Johann Wolfgang Goethe University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00326989
Brief Title
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
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johann Wolfgang Goethe University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure
Keywords
Extracorporal shock wave therapy, Cell therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
103 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low-dose shock wave treatment & Placebo
Arm Type
Active Comparator
Arm Title
low-dose shock-wave treatment & Cell therapy
Arm Type
Active Comparator
Arm Title
High-dose shock-wave treatment & Placebo
Arm Type
Active Comparator
Arm Title
High-dose shock-wave treatment & cell therapy
Arm Type
Active Comparator
Arm Title
Placebo shock-wave treatment & cell therapy
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
intracoronary stem cell therapy
Intervention Description
extracorporal shock waves prior to intracoronary cell therapy
Primary Outcome Measure Information:
Title
Improvement in global ejection fraction on LV angiography
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Global or regional wall motion at 4 months and 1 year
Time Frame
4 months
Title
NYHA Class
Time Frame
4 months
Title
NT BNP levels
Time Frame
4 months
Title
MACE
Time Frame
4 months
Title
Life quality
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas M Zeiher, MD
Organizational Affiliation
Div. of Cardiology, University of Frankfurt, Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dirk H Walter, MD
Organizational Affiliation
Div. of Cardiology, University of Frankfurt
Official's Role
Study Director
Facility Information:
Facility Name
Div. of Cardiology , University of Frankfurt
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
23592107
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. Erratum In: JAMA. 2013 May 15;309(19):1994.
Results Reference
derived
PubMed Identifier
22936827
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.
Results Reference
derived
Learn more about this trial
Cell-Wave Study: Combined Extracorporal Shock Wave Therapy and Intracoronary Cell Therapy in Chronic Ischemic Myocardium
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