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
  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:


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 ]

Enrollment: 200
Study Start Date: August 2006
Study Completion Date: November 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
Experimental: Early Procedure: intracoronary bone marrow cells infusion
intracoronary bone marrow cell infusion via a OTW balloon; "Stop-flow-technique" as previously described
Experimental: Late Procedure: intracoronary bone marrow cells infusion
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Switzerland
Cardiology, University Hospital Berne
Bern, Switzerland
Kantonsspital
Lucerne, Switzerland
Cardiocentro Ticino
Lugano, Switzerland, 6900
Cardiology, university Hospital Zurich
Zurich, Switzerland, 8091
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):
Responsible Party: Roberto Corti, MD, University of Zurich
ClinicalTrials.gov Identifier: NCT00355186     History of Changes
Other Study ID Numbers: SWISS-AMI
Study First Received: July 20, 2006
Last Updated: November 8, 2012
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
Cardiovascular Diseases
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on October 20, 2014