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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Roberto Corti, University of Zurich
ClinicalTrials.gov Identifier:
NCT00355186
First received: July 20, 2006
Last updated: November 8, 2012
Last verified: November 2012

July 20, 2006
November 8, 2012
August 2006
October 2012   (final data collection date for primary outcome measure)
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 ]
Change in global left ventricular ejection fraction (LVEF) at 4 months relative to baseline measured by quantitative MRI
Complete list of historical versions of study NCT00355186 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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
Not Provided
Not Provided
 
SWiss Multicenter Intracoronary Stem Cells Study in Acute Myocardial Infarction (SWISS-AMI)
SWiss Multicenter Intracoronary Stem Cells Study in Acute Myocardial Infarction (SWISS-AMI)

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Acute Myocardial Infarction
Procedure: intracoronary bone marrow cells infusion
intracoronary bone marrow cell infusion via a OTW balloon; "Stop-flow-technique" as previously described
  • No Intervention: Control
  • Experimental: Early
    Intervention: Procedure: intracoronary bone marrow cells infusion
  • Experimental: Late
    Intervention: Procedure: intracoronary bone marrow cells infusion

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
November 2012
October 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT00355186
SWISS-AMI
Not Provided
Roberto Corti, University of Zurich
University of Zurich
Not Provided
Principal Investigator: Roberto Corti, MD Cardiology, University Hospital Zurich, Switzerland
Study Chair: Thomas F Luescher, MD Cardiology, University Hospital Zurich
University of Zurich
November 2012

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