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

NCT00355186 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2012-11-12

No results posted yet for this study

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.

Conditions

  • Acute Myocardial Infarction

Interventions

PROCEDURE

intracoronary bone marrow cells infusion

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

Sponsors & Collaborators

  • University of Zurich

    lead OTHER

Principal Investigators

  • Roberto Corti, MD · Cardiology, University Hospital Zurich, Switzerland

  • Thomas F Luescher, MD · Cardiology, University Hospital Zurich

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-08-31
Primary Completion
2012-10-31
Completion
2012-11-30

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00355186 on ClinicalTrials.gov