Cardiovascular Disease Clinical Trial
Official title:
Statin Induced Augmentation of Circulating Endothelial Progenitor Cells and Myocardial Viability in Patients With Ischemic and Nonischemic Cardiomyopathy
NCT number | NCT00701220 |
Other study ID # | 2005H0118 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | April 2007 |
Est. completion date | December 2010 |
Verified date | June 2023 |
Source | Ohio State University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to see if taking a cholesterol lowering drug Lipitor (Atorvastatin Calcium)will increase the number of endothelial progenitor cells (EPC's) circulating in the blood of heart failure patients taking this cholesterol-lowering drug, and if this will also show an improvement in the damaged areas of the patient's hearts as documented by MRI scans.
Status | Completed |
Enrollment | 9 |
Est. completion date | December 2010 |
Est. primary completion date | December 2010 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | Inclusion Criteria: - Ischemic Cardiomyopathy (as defined above) with ejection fraction < 35% - Non-ischemic Cardiomyopathy with ejection fraction < 35% - NCEP ATPIII indication for therapy with a statin drug - No statin therapy within previous 6 months of study enrollment - Prescribed stable doses of standard heart failure therapies including beta blocking agents, angiotensin converting enzyme inhibitors or angiotensin receptor blockers, and diuretic agents as required Exclusion Criteria: - Pregnant or lactating - Myocardial infarction within 6 months preceding study enrollment - Primary valvular heart disease - Surgical or catheter based revascularization within the preceding 6 months - Documented viral or inflammatory myocarditis or cardiomyopathy - Peripartum cardiomyopathy - Infiltrative cardiomyopathies - Chemotherapy associated cardiomyopathy - Without indication for statin therapy - Contraindication to statin therapy including hepatic dysfunction, history of rhabdomyolysis or prior intolerance of statin therapy - Contraindication to magnetic resonance imaging |
Country | Name | City | State |
---|---|---|---|
United States | The Ohio State University | Columbus | Ohio |
Lead Sponsor | Collaborator |
---|---|
Philip Binkley | Pfizer |
United States,
Abstract 10678: Increase in the Number of Circulating Primordial Cells is Associated With Improved Left Ventricular Function in Dilated Cardiomyopathy Nkechinyere N Ijioma, Philip F Binkley, and Amanda Lesinski Originally published27 Mar 2018Circulation. 2013;128:A10678
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Endothelial Progenitor Cells | Change in Endothelial Progenitor Cells (EPC) was assessed by extracting white blood cells from blood samples and labeling the white blood cells using the ALDEFLOUR system. Facscan analysis was then performed first isolating lymphocytic and monocytic cell lines, which contain the EPC populations, using forward versus side scatter plots. These cells were then scanned for fluorescence in the ALDEFLUOR frequency range allowing enumeration of progenitor cell lines. The measures of fluorescent cells was compared to numbers of unstained cells having the same back scatter range to correct for any background fluorescence. | Baseline - 6 months | |
Primary | Percentage Aldofluor Positive Cells | The primary outcome measure is the percentage of cells of total analyzed that are positive for the Aldofluor assay. This commercially available assay tests cells for the enzyme aldehyde dehydrogenase that is expressed in stem cells and other early life cycle undifferentiated cells. It thus provides a measure of circulating primordial cells or cells that may serve as progenitors of destination mature cells. The percentages are designed from Facscan analysis of prepared blood cells and are quantified by quadrants defined by specific fluorescent bands and cell size distribution. The quantification of cells thus defined in the four quadrants is automatically determined by software resident in the facscan analysis system. | Baseline - 6 months |
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