NCT00669227

Brief Summary

Autologous stem cells may improve myocardial regeneration after intracoronary administration in patients with acute myocardial infarction. The primary hypothesis of this prospective, placebo-controlled, double-blind trial is that the increase of ejection fraction determined by magnetic resonance imaging between baseline and 6 months follow-up is superior in active treated patients compared to patients receiving placebo. The study includes an integrated pilot phase of 40 patients for evaluation of left ventricular ejection fraction determined by cardiac magnetic resonance imaging. Based on the data of this analysis the final sample size will be calculated. The primary endpoint is the improvement in left ventricular ejection fraction with an assumed 2.5% higher improvement in the cell treated population compared to the placebo treated group.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

April 28, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 30, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Last Updated

June 10, 2014

Status Verified

June 1, 2014

Enrollment Period

3.3 years

First QC Date

April 28, 2008

Last Update Submit

June 7, 2014

Conditions

Acute Myocardial InfarctionCoronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • difference in left ventricular ejection fraction measured by magnetic resonance imaging at baseline and 6 months follow-up

    6 months

Secondary Outcomes (4)

  • left ventricular ejection fraction measured by magnetic resonance imaging

    1, 3, 12 months

  • left ventricular enddiastolic volume measured by magnetic resonance imaging

    1, 3, 6, 12 months

  • left ventricular endsystolic volume measured by magnetic resonance imaging

    1, 3, 6, 12 months

  • major adverse cardiac events

    1, 3, 6, 12 months

Study Arms (2)

1

ACTIVE COMPARATOR

autologous stem cells, Ficoll preparation, intracoronary administration at the same day of bone marrow cell aspiration

Other: autologous stem cells

2

PLACEBO COMPARATOR

placebo is visually indistinguishable from verum due to integration of autologous erythrocytes, intracoronary administration the same day of bone marrow aspiration

Other: placebo suspension

Interventions

autologous stem cellsOTHER

intracoronary administration at the same day of cell aspiration using the stop flow technique

1
placebo suspensionOTHER

intracoronary administration at the same day as cell aspiration

2

Eligibility Criteria

Age35 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • acute myocardial infarction with time to revascularization \>6 hours from symptom start
  • clear target vessel
  • large myocardial infarction defined as: proximal vessel occlusion, CK \> 1000 U/L, myocardial scar in magnetic resonance imaging \> 10% of left ventricular muscle mass
  • potential prior thrombolysis
  • written informed consent

You may not qualify if:

  • acute myocardial infarction with revascularization within 6 hours after symptom start
  • prior myocardial infarction
  • no clear target vessel
  • contraindication for magnetic resonance imaging (e.g. pacemaker, ICD)
  • severely depressed left ventricular ejection fraction (less than 20% in magnetic resonance imaging)
  • prior hematologic disease
  • prior chemo therapy
  • prior stem cell transplantation
  • prior treatment with G-CSF
  • known alteration of the bone marrow by alcohol or drugs, e.g. agranulocytosis
  • local infection of puncture sites

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Ulm

Ulm, 89081, Germany

Location

Related Publications (2)

  • Wohrle J, Merkle N, Mailander V, Nusser T, Schauwecker P, von Scheidt F, Schwarz K, Bommer M, Wiesneth M, Schrezenmeier H, Hombach V. Results of intracoronary stem cell therapy after acute myocardial infarction. Am J Cardiol. 2010 Mar 15;105(6):804-12. doi: 10.1016/j.amjcard.2009.10.060.

    PMID: 20211323BACKGROUND

  • Wohrle J, von Scheidt F, Schauwecker P, Wiesneth M, Markovic S, Schrezenmeier H, Hombach V, Rottbauer W, Bernhardt P. Impact of cell number and microvascular obstruction in patients with bone-marrow derived cell therapy: final results from the randomized, double-blind, placebo controlled intracoronary Stem Cell therapy in patients with Acute Myocardial Infarction (SCAMI) trial. Clin Res Cardiol. 2013 Oct;102(10):765-70. doi: 10.1007/s00392-013-0595-9. Epub 2013 Jul 30.

    PMID: 23896972BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Jochen Wöhrle, MD; FESC

    University of Ulm

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. Jochen Wöhrle

Study Record Dates

First Submitted

April 28, 2008

First Posted

April 30, 2008

Study Start

October 1, 2005

Primary Completion

January 1, 2009

Last Updated

June 10, 2014

Record last verified: 2014-06

Locations

DE(1)