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

Coronary Artery Disease Clinical Trial

— SCAMI  

Official title:

Intracoronary Stem Cell Therapy in Patients With Acute Myocardial Infarction - A Randomized, Double-blind, Placebo Controlled Trial (SCAMI)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00669227
• Other study ID #: SCAMI 01-04
• Status: Completed
• Phase: Phase 2
• First received: April 28, 2008
• Last updated: June 7, 2014
• Start date: October 2005

Study information

• Verified date: June 2014
• Source: University of Ulm
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics CommissionGermany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Coronary Artery Disease
• Coronary Disease
• Infarction
• Myocardial Infarction
• Myocardial Ischemia

Intervention

Other:
• autologous stem cells
intracoronary administration at the same day of cell aspiration using the stop flow technique
• placebo suspension
intracoronary administration at the same day as cell aspiration

Locations

Country	Name	City	State
Germany	University of Ulm	Ulm

Sponsors (1)

Lead Sponsor	Collaborator
University of Ulm

Country where clinical trial is conducted

Germany, 

References & Publications (2)

Wöhrle J, Merkle N, Mailänder 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. — View Citation

Wöhrle 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	difference in left ventricular ejection fraction measured by magnetic resonance imaging at baseline and 6 months follow-up		6 months	No
Secondary	left ventricular ejection fraction measured by magnetic resonance imaging		1, 3, 12 months	No
Secondary	left ventricular enddiastolic volume measured by magnetic resonance imaging		1, 3, 6, 12 months	No
Secondary	left ventricular endsystolic volume measured by magnetic resonance imaging		1, 3, 6, 12 months	No
Secondary	major adverse cardiac events		1, 3, 6, 12 months	Yes