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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00043628 |
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Date of registration:
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09/08/2002 |
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Primary sponsor: |
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Public title:
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Stem Cell Mobilization to Treat Chest Pain and Shortness of Breath in Patients With Coronary Artery Disease
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Scientific title:
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Stem Cell Mobilization as Therapy for Chronic Myocardial Ischemia in Patients With Coronary Artery Disease |
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Date of first enrolment:
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August 2002 |
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Target sample size:
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35 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00043628 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Key inclusion & exclusion criteria
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INCLUSION CRITERIA:
Adults older than 21 years.
Functional class (CCS) 3 or 4 angina attributable to atherosclerotic CAD, despite medical
management, not optimal for mechanical revascularization due to coronary anatomy,
co-morbidity, or patient preference.
Left ventricular ejection fraction greater than 30 percent.
Inducible myocardial ischemia by dobutamine stress MRI.
No congestive heart failure symptoms within 2 months.
No active infection.
Normal renal function:creatinine less than 1.5 mg/dl, proteinuria less than 1plus
Normal liver function: bilirubin less than 1.5 mg/dl, transaminases within normal limits.
Normal blood count: WBC 3000-10000/microliter, granulocytes greater than 1500/microliter;
platelet count greater than 150,000/microliter, Hgb greater than 12.5 g/dl.
Subject understands protocol and provides written, informed consent in addition to
willingness to comply with specified follow-up evaluations.
EXCLUSION CRITERIA:
Myocardial infarction within 2 months.
Crescendo angina: Angina pectoris that is prolonged in duration (greater than 30
minutes), does not respond to nitroglycerin (3 tablets), or is occurring with increasing
frequency over the previous two weeks.
Significant structural heart disease (e.g. hypertrophic or dilated cardiomyopathy,
valvular heart disease) as determined by echocardiography.
Patients who are HIV positive, have chronic inflammatory diseases, or are on chronic
immunosuppressive medications.
Women of childbearing age unless recent pregnancy test is negative.
Lactating women.
Known active malignancy or prior history of hematologic malignancy.
Participation in unrelated research involving an investigational pharmacological agent 30
days before planned G-CSF dosing.
Contraindication for MRI.
Known hypersensitivity to E. coli-derived proteins or to gadolinium.
Age minimum:
N/A
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Coronary Artery Disease
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Intervention(s)
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Procedure: Stem Cell Mobilization
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Secondary ID(s)
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02-H-0264
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020264
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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