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Acute Myocardial InfarctionPhase 2NCT00355186

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

A Phase 2 study testing intracoronary bone marrow cells infusion in people with Acute Myocardial Infarction, run by University of Zurich at 4 sites in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Acute Myocardial Infarction
What is being tested?
intracoronary bone marrow cells infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
4 sitesSwitzerland
Study dates
Aug 2006to Nov 2012
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 15Show fewer
  • 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

Trial locations and contacts

4 sites in 1 country.

Switzerland4 sites

  • Cardiology, University Hospital Berne

    Bern

  • Kantonsspital

    Lucerne

  • Cardiocentro Ticino

    Lugano, 6900

  • Cardiology, university Hospital Zurich

    Zurich, 8091

Other trials in Switzerland

About this study

Title: SWiss multicenter Intracoronary Stem cells Study in Acute Myocardial Infarction (SWISS-AMI).

Study population: Patients with acute myocardial infarction, treated with primary PCI.

Read more

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.

Being tested
intracoronary bone marrow cells infusion
Keywords
acute myocardial infarction, MRI, bone marrow cells, stem cells, remodeling

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • intracoronary bone marrow cells infusionProcedure or surgery

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

Study groups in NCT00355186
Study groupRoleWhat they receive
ControlNo interventionNot described
EarlyExperimentalNot described
Receives: Procedure: intracoronary bone marrow cells infusion
LateExperimentalNot described
Receives: Procedure: intracoronary bone marrow cells infusion

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 4 months

Secondary outcomes (7)

  1. Change in LVEF at MRI at 12 months

    Measured: 12 months

  2. Change in regional left ventricular wall motion and thickness at 4 and 12 months

    Measured: 4 and 12 months

  3. Change in infarct size at 4 and 12 months as assessed by "delayed enhancement" technique by MRI

    Measured: 4 and 12 months

  4. 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

    Measured: baseline 4 and 12 months

  5. Change in myocardial perfusion at 4 and 12 months

    Measured: 4 and 12 months

  6. Change in serum level of amino-terminal pro-brain natriuretic peptide (NT pro-BNP)

    Measured: 4 and 12 months

  7. Major adverse cardiac events (MACE: death, myocardial infarction, TVR (ACBP or PCI, stroke, hospitalization for cardiac reasons) at 12 months

    Measured: 4 and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2006 (estimated)
  2. Study startAug 2006
  3. Primary completionOct 2012
  4. Study completionNov 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00355186
Sponsor's protocol ID
SWISS-AMI
Status last verified
Nov 2012
First submitted
20 Jul 2006
Last updated
12 Nov 2012
Results posted
No

Publications

  • 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.

    PubMed 31982162

  • 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.

    PubMed 27267068

  • 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.

    PubMed 26098589

  • 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.

    PubMed 23596006

  • 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.

    PubMed 20598973

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing intracoronary bone marrow cells infusion in people with Acute Myocardial Infarction, run by University of Zurich at 4 sites in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in global left ventricular ejection fraction (LVEF) at 4 months relative to baseline measured by quantitative MRI (time frame: 4 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00355186, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2012.

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