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Intracoronary Stem Cell Therapy in Patients With Acute Myocardial Infarction (SCAMI) (SCAMI)

Primary Purpose

Acute Myocardial Infarction, Coronary Artery Disease

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
autologous stem cells
placebo suspension
Sponsored by
University of Ulm
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myocardial Infarction

Eligibility Criteria

35 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • University of Ulm

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

left ventricular ejection fraction measured by magnetic resonance imaging
left ventricular enddiastolic volume measured by magnetic resonance imaging
left ventricular endsystolic volume measured by magnetic resonance imaging
major adverse cardiac events

Full Information

First Posted
April 28, 2008
Last Updated
June 7, 2014
Sponsor
University of Ulm
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1. Study Identification

Unique Protocol Identification Number
NCT00669227
Brief Title
Intracoronary Stem Cell Therapy in Patients With Acute Myocardial Infarction (SCAMI)
Acronym
SCAMI
Official Title
Intracoronary Stem Cell Therapy in Patients With Acute Myocardial Infarction - A Randomized, Double-blind, Placebo Controlled Trial (SCAMI)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Ulm

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
There is a 2:1 randomization for bone marrow cell therapy versus placebo therapy. Patients will be stratified according to age, localization of myocardial infarction and left ventricular function.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction, Coronary Artery Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
autologous stem cells, Ficoll preparation, intracoronary administration at the same day of bone marrow cell aspiration
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
placebo is visually indistinguishable from verum due to integration of autologous erythrocytes, intracoronary administration the same day of bone marrow aspiration
Intervention Type
Other
Intervention Name(s)
autologous stem cells
Intervention Description
intracoronary administration at the same day of cell aspiration using the stop flow technique
Intervention Type
Other
Intervention Name(s)
placebo suspension
Intervention Description
intracoronary administration at the same day as cell aspiration
Primary Outcome Measure Information:
Title
difference in left ventricular ejection fraction measured by magnetic resonance imaging at baseline and 6 months follow-up
Time Frame
6 months
Secondary Outcome Measure Information:
Title
left ventricular ejection fraction measured by magnetic resonance imaging
Time Frame
1, 3, 12 months
Title
left ventricular enddiastolic volume measured by magnetic resonance imaging
Time Frame
1, 3, 6, 12 months
Title
left ventricular endsystolic volume measured by magnetic resonance imaging
Time Frame
1, 3, 6, 12 months
Title
major adverse cardiac events
Time Frame
1, 3, 6, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jochen Wöhrle, MD; FESC
Organizational Affiliation
University of Ulm
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Ulm
City
Ulm
ZIP/Postal Code
89081
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
20211323
Citation
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.
Results Reference
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PubMed Identifier
23896972
Citation
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.
Results Reference
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Intracoronary Stem Cell Therapy in Patients With Acute Myocardial Infarction (SCAMI)

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