SWiss Multicenter Intracoronary Stem Cells Study in Acute Myocardial Infarction (SWISS-AMI) - Full Text View

Sponsor:	University of Zurich
Information provided by:	University of Zurich
ClinicalTrials.gov Identifier:	NCT00355186

Purpose

Title: SWiss multicenter Intracoronary Stem cells Study in Acute Myocardial Infarction (SWISS-AMI).

Study population: Patients with acute myocardial infarction, treated with primary PCI.

Objective: To determine whether intracoronary infusion of BMCs improves recovery of left ventricular function after acute myocardial infarction treated by PCI

Design: Multi-center, randomized, controlled clinical trial with central core lab analysis for MRI.

Therapy: Intracoronary infusion of BMCs in the infarct related artery at 5-7 days or 3-4 weeks after successful primary PCI

Primary Endpoint: Change in global left ventricular ejection fraction (LVEF) at 4 months relative to baseline measured by quantitative MRI.

Secondary Endpoints:

Change in LVEF at MRI at 12 months
Change in regional left ventricular wall motion and thickness at 4 and 12 months.
Change in infarct size at 4 and 12 months as assessed by "delayed enhancement" technique by MRI
Analysis of the myocardial infarct size and transmurality, time to PCI and coronary flow characteristics after PCI as predictor of LV remodeling and change after cell therapy
Change in myocardial perfusion at 4 and 12 months
Change in serum level of amino-terminal pro-brain natriuretic peptide (NT pro-BNP)
Major adverse cardiac events (MACE: death, myocardial infarction, TVR (ACBP or PCI, stroke, hospitalization for cardiac reasons) at 12 months

Interventions:

Aspiration of 50 ml bone marrow (<24 hours) prior to administration
Intracoronary balloon-based infusion of 10 ml BMCs
Cardiac MRI at baseline (resp. at hospital discharge), at 4 and 12 months

Therapy groups: Bone marrow-derived stem cells infusion in the successfully revascularized infarct related vessel at day 5-7 or day 21-28.

Control group: Management according to the "state of the art" medical therapy after successful primary PCI.

Safety: A study independent "safety committee" will analyze the clinical results after the first 60 patients.

Condition	Intervention	Phase
Acute Myocardial Infarction	Procedure: intracoronary bone marrow cells infusion	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	SWiss Multicenter Intracoronary Stem Cells Study in Acute Myocardial Infarction (SWISS-AMI)

Resource links provided by NLM:

MedlinePlus related topics: Heart Attack

U.S. FDA Resources

Further study details as provided by University of Zurich:

Primary Outcome Measures:

Change in global left ventricular ejection fraction (LVEF) at 4 months relative to baseline measured by quantitative MRI [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in LVEF at MRI at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Change in regional left ventricular wall motion and thickness at 4 and 12 months [ Time Frame: 4 and 12 months ] [ Designated as safety issue: No ]
Change in infarct size at 4 and 12 months as assessed by "delayed enhancement" technique by MRI [ Time Frame: 4 and 12 months ] [ Designated as safety issue: No ]
Analysis of the myocardial infarct size and transmurality transmurality, time to PCI and coronary flow characteristics after PCI as predictor of LV remodeling and change after cell therapy [ Time Frame: baseline 4 and 12 months ] [ Designated as safety issue: No ]
Change in myocardial perfusion at 4 and 12 months [ Time Frame: 4 and 12 months ] [ Designated as safety issue: No ]
Change in serum level of amino-terminal pro-brain natriuretic peptide (NT pro-BNP) [ Time Frame: 4 and 12 months ] [ Designated as safety issue: No ]
Major adverse cardiac events (MACE: death, myocardial infarction, TVR (ACBP or PCI, stroke, hospitalization for cardiac reasons) at 12 months [ Time Frame: 4 and 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	150
Study Start Date:	August 2006
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Intervention Details:

intracoronary bone marrow cell infusion via a OTW balloon; "Stop-flow-technique" as previously described

Eligibility

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Visual LVEF at angiogram or echocardiography ≤45%
Treatment by primary PCI within 24 hours of the onset of chest pain or initial treatment with thrombolysis within the 12 hours followed by PCI within the 24 hours of the onset of chest pain
Significant regional LV wall motion dysfunction in the infarct related territory
Age >18 years

Exclusion Criteria:

Abnormal regional wall motion outside the infarct region
Known previous myocardial infarction in the same target vessel
Known pre-existing left ventricular dysfunction (EF<45% prior to admission)
Need for revascularization in the non infarct-related coronary within 4 months
Pre-existing symptoms of heart failure or known cardiomyopathy
Known active infection or chronic infection with HIV, HBV or HCV
Chronic inflammatory disease
Serious concomitant disease with a life expectancy of less than one year
Follow up impossible (no fixed abode, etc)
Contraindication for cardiac MRI (i.e. pace maker, neurostimulator, claustrophobia)
Severe renal failure (creatinine >250 mmol/l)
Relevant liver disease (GOT > 2x norm or spontaneous INR > 1,5)
Anemia (Hb < 8.5 mg/dl), Thrombocytopenia (<100.000/µl)
Pregnancy
Participation at a clinical trial in the last 30 days

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00355186

Contacts

Contact: Roberto Corti, MD

0041 44 255 1111

roberto.corti@usz.ch

Locations

Switzerland
Cardiology, University Hospital Berne	Recruiting
Bern, Switzerland
Contact: Otto M Hess, MD
Principal Investigator: Stephan Windecker, MD
Kantonsspital	Recruiting
Lucerne, Switzerland
Contact: Paul Erne, Professor
Cardiocentro Ticino	Recruiting
Lugano, Switzerland, 6900
Contact: Tiziano Moccetti, MD 0041 91 805 3111
Principal Investigator: Tiziano Moccetti, MD
Cardiology, university Hospital Zurich	Recruiting
Zurich, Switzerland, 8091
Contact: Roberto Corti, MD 0041 44 255 1111 roberto.corti@usz.ch
Sub-Investigator: Daniel Surder, MD

Sponsors and Collaborators

University of Zurich

Investigators

Principal Investigator:	Roberto Corti, MD	Cardiology, University Hospital Zurich, Switzerland
Study Chair:	Thomas F Luescher, MD	Cardiology, University Hospital Zurich

More Information

No publications provided by University of Zurich

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Sürder D, Schwitter J, Moccetti T, Astori G, Rufibach K, Plein S, Cicero VL, Soncin S, Windecker S, Moschovitis A, Wahl A, Erne P, Jamshidi P, Auf der Maur C, Manka R, Soldati G, Bühler I, Wyss C, Landmesser U, Lüscher TF, Corti R. Cell-based therapy for myocardial repair in patients with acute myocardial infarction: rationale and study design of the SWiss multicenter Intracoronary Stem cells Study in Acute Myocardial Infarction (SWISS-AMI). Am Heart J. 2010 Jul;160(1):58-64.

Responsible Party:	University of Zurich
ClinicalTrials.gov Identifier:	NCT00355186 History of Changes
Other Study ID Numbers:	SWISS-AMI
Study First Received:	July 20, 2006
Last Updated:	June 25, 2008
Health Authority:	Switzerland: Swissmedic

Keywords provided by University of Zurich:

acute myocardial infarction
MRI
bone marrow cells
stem cells
remodeling

Additional relevant MeSH terms:

Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis

Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 24, 2012