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

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ClinicalTrials.gov Identifier: NCT00355186
Recruitment Status : Completed
First Posted : July 21, 2006
Last Update Posted : November 12, 2012
Sponsor:
Information provided by (Responsible Party):
Roberto Corti, University of Zurich

Tracking Information
First Submitted Date  ICMJE July 20, 2006
First Posted Date  ICMJE July 21, 2006
Last Update Posted Date November 12, 2012
Study Start Date  ICMJE August 2006
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 25, 2008)
Change in global left ventricular ejection fraction (LVEF) at 4 months relative to baseline measured by quantitative MRI [ Time Frame: 4 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 20, 2006)
Change in global left ventricular ejection fraction (LVEF) at 4 months relative to baseline measured by quantitative MRI
Change History Complete list of historical versions of study NCT00355186 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 25, 2008)
  • Change in LVEF at MRI at 12 months [ Time Frame: 12 months ]
  • Change in regional left ventricular wall motion and thickness at 4 and 12 months [ Time Frame: 4 and 12 months ]
  • Change in infarct size at 4 and 12 months as assessed by "delayed enhancement" technique by MRI [ Time Frame: 4 and 12 months ]
  • 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 ]
  • Change in myocardial perfusion at 4 and 12 months [ Time Frame: 4 and 12 months ]
  • Change in serum level of amino-terminal pro-brain natriuretic peptide (NT pro-BNP) [ Time Frame: 4 and 12 months ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 20, 2006)
  • 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 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE SWiss Multicenter Intracoronary Stem Cells Study in Acute Myocardial Infarction (SWISS-AMI)
Official Title  ICMJE SWiss Multicenter Intracoronary Stem Cells Study in Acute Myocardial Infarction (SWISS-AMI)
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute Myocardial Infarction
Intervention  ICMJE Procedure: intracoronary bone marrow cells infusion
intracoronary bone marrow cell infusion via a OTW balloon; "Stop-flow-technique" as previously described
Study Arms  ICMJE
  • No Intervention: Control
  • Experimental: Early
    Intervention: Procedure: intracoronary bone marrow cells infusion
  • Experimental: Late
    Intervention: Procedure: intracoronary bone marrow cells infusion
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 8, 2012)
200
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE November 2012
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00355186
Other Study ID Numbers  ICMJE SWISS-AMI
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Roberto Corti, University of Zurich
Study Sponsor  ICMJE University of Zurich
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Roberto Corti, MD Cardiology, University Hospital Zurich, Switzerland
Study Chair: Thomas F Luescher, MD Cardiology, University Hospital Zurich
PRS Account University of Zurich
Verification Date November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP