SCAMI - Autologous Stem Cells for Regeneration After Acute Myocardial Infarction - Full Text View

Sponsored by:	University of Ulm
Information provided by:	University of Ulm
ClinicalTrials.gov Identifier:	NCT00669227

Purpose

Autologous stem cells may improve myocardial regeneration after intracoronary administration in patients with acute myocardial infarction. The primary hypothesis of this prospective, placebo-controlled, double-blind trial is that the increase of ejection fraction determined by magnetic resonance imaging between baseline and 6 months follow-up is superior in active treated patients compared to patients receiving placebo.

Condition	Intervention	Phase
Acute Myocardial Infarction Coronary Artery Disease	Other: autologous stem cells Other: placebo	Phase II

MedlinePlus related topics: Coronary Artery Disease Heart Attack MRI Scans

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Autologous Stem Cells for Regeneration After Acute Myocardial Infarction

Further study details as provided by University of Ulm:

Primary Outcome Measures:

left ventricular ejection fraction measured by magnetic resonance imaging [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

left ventricular ejection fraction measured by magnetic resonance imaging [ Time Frame: 1, 3, 12 months ] [ Designated as safety issue: No ]
left ventricular enddiastolic volume measured by magnetic resonance imaging [ Time Frame: 1, 3, 6, 12 months ] [ Designated as safety issue: No ]
left ventricular endsystolic volume measured by magnetic resonance imaging [ Time Frame: 1, 3, 6, 12 months ] [ Designated as safety issue: No ]
major adverse cardiac events [ Time Frame: 1, 3, 6, 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	75
Study Start Date:	October 2005
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator autologous stem cells, Ficoll preparation, intracoronary administration at the same day of extraction	Other: autologous stem cells intracoronary administration same day of extraction stop flow technique
2: Placebo Comparator intracoronary administration of a placebo suspension	Other: placebo intracoronary administration at the same day as extraction of autologous stem cells

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

acute myocardial infarction with time to revascularization >6 hours from symptom start
clear target vessel
large myocardial infarction defined as one of the following: proximal vessel occlusion, CK > 1000 U/L, myocardial scar in magnetic resonance imaging > 10% of left ventricular muscle mass
potential prior thrombolysis
written informed consent

Exclusion Criteria:

acute myocardial infarction with revascularization within 6 hours after symptom start
prior myocardial infarction in the same territory
no clear target vessel
contraindication for magnetic resonance imaging (e.g. pacemaker, ICD)
severely depressed left ventricular ejection fraction (less than 20% in magnetic resonance imaging)
prior hematologic disease
prior chemo therapy
prior stem cell transplantation
prior treatment with G-CSF
known alteration of the bone marrow by alcohol or drugs, e.g. agranulocytosis
local infection of puncture sites

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00669227

Contacts

Contact: Jochen Wöhrle, MD, FESC

49-731-500-45028

jochen.woehrle@uniklinik-ulm.de

Locations

Germany
University of Ulm	Recruiting
Ulm, Germany, 89081
Contact: Jochen Wöhrle, MD; FESC 49-731-500-45028 jochen.woehrle@uniklinik-ulm.de
Principal Investigator: Jochen Wöhrle, MD, FESC
Sub-Investigator: Hubert Schrezenmeier, MD
Sub-Investigator: Thorsten Nusser, MD
Sub-Investigator: Markus Wiesneth, MD
Sub-Investigator: Jan Torzewski, MD
Sub-Investigator: Volker Mailänder, MD
Sub-Investigator: Thomas Habig, MD

Sponsors and Collaborators

University of Ulm

Investigators

Principal Investigator:

Jochen Wöhrle, MD; FESC

University of Ulm

More Information

Responsible Party:	University of Ulm ( Jochen Wöhrle, MD, FESC )
Study ID Numbers:	SCAMI 01-04
Study First Received:	April 28, 2008
Last Updated:	April 29, 2008
ClinicalTrials.gov Identifier:	NCT00669227
Health Authority:	Germany: Ethics Commission; Germany: Federal Institute for Drugs and Medical Devices

Study placed in the following topic categories:

Arterial Occlusive Diseases
Coronary Disease
Necrosis
Heart Diseases
Myocardial Ischemia
Vascular Diseases

Arteriosclerosis
Ischemia
Infarction
Myocardial Infarction
Coronary Artery Disease

Additional relevant MeSH terms:

Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009