NCT00326989

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started May 2006

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

May 16, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 17, 2006

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

March 21, 2017

Status Verified

March 1, 2017

Enrollment Period

5.3 years

First QC Date

May 16, 2006

Last Update Submit

March 20, 2017

Conditions

Congestive Heart Failure

Keywords

Extracorporal shock wave therapyCell therapy

Outcome Measures

Primary Outcomes (1)

  • Improvement in global ejection fraction on LV angiography

    4 months

Secondary Outcomes (5)

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

    4 months

  • NYHA Class

    4 months

  • NT BNP levels

    4 months

  • MACE

    4 months

  • Life quality

    4 months

Study Arms (5)

Low-dose shock wave treatment & Placebo

ACTIVE COMPARATOR
Procedure: intracoronary stem cell therapy

low-dose shock-wave treatment & Cell therapy

ACTIVE COMPARATOR
Procedure: intracoronary stem cell therapy

High-dose shock-wave treatment & Placebo

ACTIVE COMPARATOR
Procedure: intracoronary stem cell therapy

High-dose shock-wave treatment & cell therapy

ACTIVE COMPARATOR
Procedure: intracoronary stem cell therapy

Placebo shock-wave treatment & cell therapy

ACTIVE COMPARATOR
Procedure: intracoronary stem cell therapy

Interventions

intracoronary stem cell therapyPROCEDURE

extracorporal shock waves prior to intracoronary cell therapy

High-dose shock-wave treatment & PlaceboHigh-dose shock-wave treatment & cell therapyLow-dose shock wave treatment & PlaceboPlacebo shock-wave treatment & cell therapylow-dose shock-wave treatment & Cell therapy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Div. of Cardiology , University of Frankfurt

Frankfurt, 60590, Germany

Location

Related Publications (2)

  • 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.

    PMID: 23592107DERIVED

  • 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.

    PMID: 22936827DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Andreas M Zeiher, MD

    Div. of Cardiology, University of Frankfurt, Germany

    PRINCIPAL INVESTIGATOR

  • Dirk H Walter, MD

    Div. of Cardiology, University of Frankfurt

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. Andreas M. Zeiher

Study Record Dates

First Submitted

May 16, 2006

First Posted

May 17, 2006

Study Start

May 1, 2006

Primary Completion

September 1, 2011

Study Completion

December 1, 2011

Last Updated

March 21, 2017

Record last verified: 2017-03

Locations

DE(1)