Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
75 participants
INTERVENTIONAL
2002-01-31
2005-01-31
Brief Summary
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The aim of the current trial is to investigate whether infusion of progenitor cells into the coronary artery supplying the most dyskinetic left ventricular area may improve left ventricular contractile function, compared to no cell infusion in the control group, in patients with old (\>= 3 months) myocardial infarction.
Detailed Description
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* Patients post myocardial infarction (\>= 3 months) with a patent infarct-related artery are included.
* Bone marrow-derived progenitor cells are aspirated under local anaesthesia, and after cell processing, are infused into the patent infarct-related artery during stop flow within the same day. Blood-derived progenitor cells are isolated out of 250ml peripheral venous blood, and after cell processing and 3 days culture, are infused into the patent infarct-related artery during stop flow. In addition, left ventricular angiography is performed. In the control group coronary angiography and left ventricular angiography without any intracoronary infusion are performed.
* After 3 months, left ventricular angiography is repeated, and patients of the control group cross-over to active treatment with progenitor cells, whereas patients initially treated with progenitor cells cross-over to the alternate cell type.
* The primary endpoint is the change in quantitative global left ventricular ejection fraction in LV angiography between the groups.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Interventions
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intracoronary infusion of progenitor cells
Eligibility Criteria
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Inclusion Criteria
* Patients post-myocardial infarction (\> 3 months old) or with diffuse ischemic CHD
* Signed informed consent
Exclusion Criteria
* Active infection
* Active internal bleeding
* Stroke within the past 2 years
* Surgery or trauma within the past two months
* Uncontrolled hypertension over 160/100
* Arteriovenous malformations or aneurysms
* HIV infection
* Signs of significant kidney or liver failure (creatinine \> 2.0 mg/dL, GOT \> 2 x upper standard value)
* Thrombopenia (\< 100,000)
* Anemia (hemoglobin \< 8.5 g/dL)
* Mental retardation
* Participation in another clinical study
* Women of childbearing age
* Chronic inflammatory disease
18 Years
80 Years
ALL
No
Sponsors
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Johann Wolfgang Goethe University Hospital
OTHER
Principal Investigators
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Andreas M Zeiher, MD
Role: PRINCIPAL_INVESTIGATOR
J. W. Goethe University Hospitals
Volker Schaechinger, MD
Role: STUDY_DIRECTOR
J. W. Goethe University Hospitals
Locations
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J. W. Goethe University Hospitals
Frankfurt, , Germany
Countries
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References
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Assmus B, Honold J, Schachinger V, Britten MB, Fischer-Rasokat U, Lehmann R, Teupe C, Pistorius K, Martin H, Abolmaali ND, Tonn T, Dimmeler S, Zeiher AM. Transcoronary transplantation of progenitor cells after myocardial infarction. N Engl J Med. 2006 Sep 21;355(12):1222-32. doi: 10.1056/NEJMoa051779.
De Rosa S, Seeger FH, Honold J, Fischer-Rasokat U, Lehmann R, Fichtlscherer S, Schachinger V, Dimmeler S, Zeiher AM, Assmus B. Procedural safety and predictors of acute outcome of intracoronary administration of progenitor cells in 775 consecutive procedures performed for acute myocardial infarction or chronic heart failure. Circ Cardiovasc Interv. 2013 Feb;6(1):44-51. doi: 10.1161/CIRCINTERVENTIONS.112.971705. Epub 2013 Jan 29.
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.
Other Identifiers
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158/02
Identifier Type: -
Identifier Source: org_study_id