Safety and Efficacy of Bone Marrow Cell Transplantation in Humans Myocardial Infarction (CARDIAC)
Primary Purpose
Acute Myocardial Infarction
Status
Unknown status
Phase
Phase 1
Locations
Italy
Study Type
Interventional
Intervention
cell therapy, bone marrow derived stem cell
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myocardial Infarction focused on measuring bone marrow, cell transplantation, stem cells, PTCA
Eligibility Criteria
Inclusion Criteria:
- Recent acute transmural anterior myocardial infarction, (in agreement with WHO)
- single left anterior descending coronary artery disease
- <72 hour from the origin of symptoms
- successful primary angioplasty of the culprit lesion
Exclusion Criteria:
- screening >72 hours after infarction,
- cardiac shock, severe comorbidity, alcohol or drug dependency
- severe comorbidity (DM,renal or liver insufficiency)
- potential child bearing woman
- inability to provide informed consent
Sites / Locations
- G da Saliceto HospitalRecruiting
Outcomes
Primary Outcome Measures
Mortality
Mortality and Morbidity
Left ventricular function
Secondary Outcome Measures
Left ventricular remodeling
Heart rate variability
Baroreflex sensitivity
Stress induced myocardial ischemia
Cell dose response
Full Information
NCT ID
NCT00437710
First Posted
February 20, 2007
Last Updated
March 23, 2010
Sponsor
Azienda Unità Sanitaria Locale di Piacenza
1. Study Identification
Unique Protocol Identification Number
NCT00437710
Brief Title
Safety and Efficacy of Bone Marrow Cell Transplantation in Humans Myocardial Infarction
Acronym
CARDIAC
Official Title
Cardiac Study. Cellular Cardiomyoplasty of Infarcted Failed Myocardium by Autologous Intracoronary Mononuclear Bone Marrow Cell Transplantation in Humans
Study Type
Interventional
2. Study Status
Record Verification Date
February 2007
Overall Recruitment Status
Unknown status
Study Start Date
July 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2007 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Azienda Unità Sanitaria Locale di Piacenza
4. Oversight
5. Study Description
Brief Summary
We will study in a prospective randomised fashion 50 patients who will be treated by intracoronary transplantation of autologous, mononuclear bone marrow cells (BMCs) in addition to standard therapy after MI or standard therapy.
After standard therapy for acute MI, 10 patients were transplanted with autologous mononuclear BMCs via a balloon catheter placed into the infarct-related artery during balloon dilatation (percutaneous transluminal coronary angioplasty). Another 10 patients with acute MI were treated by standard therapy alone. After
Detailed Description
Experimental and clinical data suggest that bone marrow-derived cells may contribute to the healing of myocardial infarction (MI).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction
Keywords
bone marrow, cell transplantation, stem cells, PTCA
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
cell therapy, bone marrow derived stem cell
Primary Outcome Measure Information:
Title
Mortality
Title
Mortality and Morbidity
Title
Left ventricular function
Secondary Outcome Measure Information:
Title
Left ventricular remodeling
Title
Heart rate variability
Title
Baroreflex sensitivity
Title
Stress induced myocardial ischemia
Title
Cell dose response
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Recent acute transmural anterior myocardial infarction, (in agreement with WHO)
single left anterior descending coronary artery disease
<72 hour from the origin of symptoms
successful primary angioplasty of the culprit lesion
Exclusion Criteria:
screening >72 hours after infarction,
cardiac shock, severe comorbidity, alcohol or drug dependency
severe comorbidity (DM,renal or liver insufficiency)
potential child bearing woman
inability to provide informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Massimo Piepoli, MD, PhD
Phone
+390 523 303217
Email
m.piepoli@ausl.pc.it
First Name & Middle Initial & Last Name or Official Title & Degree
Daniele Vallisa, MD
Phone
+390 523 303737
Email
d.vallisa@ausl.pc.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Massimo Piepoli, MD, PhD
Organizational Affiliation
G. da Saliceto Hospital, Regional Health Authority
Official's Role
Principal Investigator
Facility Information:
Facility Name
G da Saliceto Hospital
City
Piacenza
ZIP/Postal Code
29100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Massimo Piepoli, MD
Phone
+390 523 303217
Email
m.piepoli@ausl.pc.it
First Name & Middle Initial & Last Name & Degree
Daniele Vallisa, MD
Phone
+390 523 303737
Email
d.vallisa@ausl.pc.it
First Name & Middle Initial & Last Name & Degree
Massimo Piepoli, MD, PhD
12. IPD Sharing Statement
Links:
URL
http://www.ausl.pc.it/
Description
Azienda USL Piacenza web site
Learn more about this trial
Safety and Efficacy of Bone Marrow Cell Transplantation in Humans Myocardial Infarction
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