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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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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.
This study involves the testing of blood for cholesterol levels and flow cytometry tests to count the number of EPC's in your blood. These tests are routinely performed to gain knowledge about a person's health. If any incidental findings are identified as a result of your participation in this research study, you will be notified and referred to your doctor or appropriate health care professional.
You are being asked to provide a blood sample that will be used to determine the usual numbers of EPC's circulating in the blood of healthy people who have no risk factors for heart disease. Your results will be compared with those of patients who have heart failure.
Flow cytometry is a special laboratory test that can count, separate, and detect characteristics of cells in blood. Your blood sample will be analyzed using flow cytometry. Endothelial progenitor cells (EPC's) are immature cells that are necessary for new blood vessel formation. EPC's will be separated by flow cytometry and counted. You will not be given the results of your flow cytometry study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ischemic Cardiomyopathy | Active Comparator | Patients with Ischemic Cardiomyopathy receiving Lipitor (Atorvastatin calcium). |
|
| Non Ischemic Cardiomyopathy | Active Comparator | NonIschemic Cardiomyopathy receiving Lipitor (Atorvastatin calcium) treatment |
|
| Healthy Subjects | No Intervention | Healthy subjects with no history of high cholesterol, heart disease, or heart attacks |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atorvastatin Calcium | Drug | Atorvastatin Calcium starting at a 10 mg dose and may be increased up to 40 mg dose until cholesterol is lowered to an acceptable range. Blood will drawn every 2 weeks for the first 12 weeks to check the cholesterol level and adjust medication dosage. Cardiac MRI will be performed at the beginning and at the end of the 6 month study to measure the physical changes of the heart. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philip Binkley, MD, MPH | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University | Columbus | Ohio | 43210 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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 |
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available through request to the principal investigator; has been presented as an abstract but not a published paper
Is available now and indefinitely
Investigators in the field of biomedical research
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Patients with cardiomyopathy on the basis of valvular heart disease or who had a myocardial infarction within six months prior to study enrollment were excluded from the study.
Patients were eligible for enrollment if they had dilated cardiomyopathy w/ an established ejection fraction < 35% on a nonischemic or ischemic basis. All pts had clinical indication for treatment w/ a statin Rx & did not receive a statin medication prior to enrollment in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ischemic Cardiomyopathy | Patients with Ischemic Cardiomyopathy receiving Lipitor. |
| FG001 | NonIschemic Cardiomyopathy | NonIschemic Cardiomyopathy receiving Lipitor treatment |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ischemic Cardiomyopathy | Patients with Ischemic Cardiomyopathy receiving Lipitor. |
| BG001 | NonIschemic Cardiomyopathy | NonIschemic Cardiomyopathy receiving Lipitor treatment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | Percentage of EPCs | Baseline - 6 months |
|
Six months
Adverse events obtained by participant examination and interview
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ischemic Cardiomyopathy | Patients with Ischemic Cardiomyopathy receiving Lipitor. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Philip F. Binkley, MD, MPH | The Ohio State University | (614) 293-3956 | binkley.2@osu.edu |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D009202 | Cardiomyopathies |
| D006331 | Heart Diseases |
| D017202 | Myocardial Ischemia |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| NonIschemic Cardiomyopathy |
NonIschemic Cardiomyopathy receiving Lipitor (Atorvastatin Calcium) treatment |
|
|
| 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. | Posted | Mean | Standard Deviation | Percentage Aldefluor positive cells | Baseline - 6 months |
|
|
|
|
| 0 |
| 1 |
| 0 |
| 1 |
| EG001 | NonIschemic Cardiomyopathy | NonIschemic Cardiomyopathy receiving Lipitor treatment | 0 | 4 | 0 | 4 |
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| D006538 |
| Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |