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

November 8, 2012 updated by: Roberto Corti, University of Zurich

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Bern, Switzerland
        • Cardiology, University Hospital Berne
      • Lucerne, Switzerland
        • Kantonsspital
      • Lugano, Switzerland, 6900
        • Cardiocentro Ticino
      • Zurich, Switzerland, 8091
        • Cardiology, University Hospital Zurich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in global left ventricular ejection fraction (LVEF) at 4 months relative to baseline measured by quantitative MRI
Time Frame: 4 months
4 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in LVEF at MRI at 12 months
Time Frame: 12 months
12 months
Change in regional left ventricular wall motion and thickness at 4 and 12 months
Time Frame: 4 and 12 months
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
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
baseline 4 and 12 months
Change in myocardial perfusion at 4 and 12 months
Time Frame: 4 and 12 months
4 and 12 months
Change in serum level of amino-terminal pro-brain natriuretic peptide (NT pro-BNP)
Time Frame: 4 and 12 months
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
4 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

July 20, 2006

First Submitted That Met QC Criteria

July 20, 2006

First Posted (Estimate)

July 21, 2006

Study Record Updates

Last Update Posted (Estimate)

November 12, 2012

Last Update Submitted That Met QC Criteria

November 8, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SWISS-AMI

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acute Myocardial Infarction

Clinical Trials on intracoronary bone marrow cells infusion

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Africa

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe