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

University of Zurich (UZH)

Status and phase

Completed

Phase 2

Conditions

Acute Myocardial Infarction

Treatments

Procedure: intracoronary bone marrow cells infusion

Study type

Interventional

Funder types

Other

Identifiers

NCT00355186

SWISS-AMI

Details and patient eligibility

About

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.

Enrollment

200 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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