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

NCT00355186 | Completed Phase 2

• 1 other identifier: SWISS-AMI
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 4

Brief 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

Keywords

acute myocardial infarction; MRI; bone marrow cells; stem cells; remodeling

Outcome Measures

Primary Outcomes (1)

• Change in global left ventricular ejection fraction (LVEF) at 4 months relative to baseline measured by quantitative MRI

  4 months

Secondary Outcomes (7)

• Change in LVEF at MRI at 12 months

  12 months

• Change in regional left ventricular wall motion and thickness at 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

  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

  baseline 4 and 12 months

• Change in myocardial perfusion at 4 and 12 months

  4 and 12 months

Study Arms (3)

Control

NO INTERVENTION

Early

EXPERIMENTAL

Procedure: intracoronary bone marrow cells infusion

Late

EXPERIMENTAL

Procedure: intracoronary bone marrow cells infusion

Interventions

intracoronary bone marrow cells infusion PROCEDURE

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

Early; Late

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (4)

Cardiology, University Hospital Berne

Bern, Switzerland

Location

Kantonsspital

Lucerne, Switzerland

Location

Cardiocentro Ticino

Lugano, 6900, Switzerland

Location

Cardiology, university Hospital Zurich

Zurich, 8091, Switzerland

Location

Related Publications (5)

• Gastl M, Surder D, Corti R, Faruque Osmany DMM, Gotschy A, von Spizcak J, Sokolska J, Metzen D, Alkadhi H, Ruschitzka F, Kozerke S, Manka R. Effect of intracoronary bone marrow-derived mononuclear cell injection early and late after myocardial infarction on CMR-derived myocardial strain. Int J Cardiol. 2020 Jul 1;310:108-115. doi: 10.1016/j.ijcard.2020.01.025. Epub 2020 Jan 15.

  PMID: 31982162 DERIVED

• Surder D, Manka R, Moccetti T, Lo Cicero V, Emmert MY, Klersy C, Soncin S, Turchetto L, Radrizzani M, Zuber M, Windecker S, Moschovitis A, Buhler I, Kozerke S, Erne P, Luscher TF, Corti R. Effect of Bone Marrow-Derived Mononuclear Cell Treatment, Early or Late After Acute Myocardial Infarction: Twelve Months CMR and Long-Term Clinical Results. Circ Res. 2016 Jul 22;119(3):481-90. doi: 10.1161/CIRCRESAHA.116.308639. Epub 2016 Jun 6.

  PMID: 27267068 DERIVED

• Surder D, Gisler V, Corti R, Moccetti T, Klersy C, Zuber M, Windecker S, Moschovitis A, Kozerke S, Luscher TF, Erne P, Manka R. Thrombus formation in the left ventricle after large myocardial infarction - assessment with cardiac magnetic resonance imaging. Swiss Med Wkly. 2015 Jun 22;145:w14122. doi: 10.4414/smw.2015.14122. eCollection 2015.

  PMID: 26098589 DERIVED

• Surder D, Manka R, Lo Cicero V, Moccetti T, Rufibach K, Soncin S, Turchetto L, Radrizzani M, Astori G, Schwitter J, Erne P, Zuber M, Auf der Maur C, Jamshidi P, Gaemperli O, Windecker S, Moschovitis A, Wahl A, Buhler I, Wyss C, Kozerke S, Landmesser U, Luscher TF, Corti R. Intracoronary injection of bone marrow-derived mononuclear cells early or late after acute myocardial infarction: effects on global left ventricular function. Circulation. 2013 May 14;127(19):1968-79. doi: 10.1161/CIRCULATIONAHA.112.001035. Epub 2013 Apr 17.

  PMID: 23596006 DERIVED

• Surder D, Schwitter J, Moccetti T, Astori G, Rufibach K, Plein S, Lo Cicero V, Soncin S, Windecker S, Moschovitis A, Wahl A, Erne P, Jamshidi P, Auf der Maur C, Manka R, Soldati G, Buhler I, Wyss C, Landmesser U, Luscher TF, Corti R. Cell-based therapy for myocardial repair in patients with acute myocardial infarction: rationale and study design of the SWiss multicenter Intracoronary Stem cells Study in Acute Myocardial Infarction (SWISS-AMI). Am Heart J. 2010 Jul;160(1):58-64. doi: 10.1016/j.ahj.2010.03.039.

  PMID: 20598973 DERIVED

Study Officials

• Roberto Corti, MD

  Cardiology, University Hospital Zurich, Switzerland

  PRINCIPAL INVESTIGATOR

• Thomas F Luescher, MD

  Cardiology, University Hospital Zurich

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 20, 2006
• First Posted: July 21, 2006
• Study Start: August 1, 2006
• Primary Completion: October 1, 2012
• Study Completion: November 1, 2012
• Last Updated: November 12, 2012

Record last verified: 2012-11

Locations

CH (4)