Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Losordo, Douglas, M.D.
Age
21–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Be \> 21 years old.
Have mild or moderate (NYHA Class II or III) CHF secondary to ischemic heart disease.
Have left ventricular ejection fraction \<40%.
Patients must have total occlusion of one or more extramural coronary arteries demonstrated by diagnostic angiography within 6 months prior to study enrollment.
Patients must be on a stable cardiac medical regimen (i.e. the same anti-anginal and anti-congestive medications) for 1 month prior to determination of their baseline functional status. The judgment regarding the optimal medical regimen for each individual subject will have been made by the referring cardiologist.
Subjects must be identified as non-candidates for conventional revascularization by their referring cardiologist.
Have serum B-type Natriuretic Peptide (BNP) level \>100 pg/ml.
Women of childbearing potential must agree not to become pregnant during the course of the study. Nonsterile men participating in the study must also agree not to impregnate their partners.
Have the ability to understand the requirements of the study, provide written informed consent, abide by the study restrictions, and agree to return for the required assessments.
You may not be if
Have a history of alcohol or drug abuse within 3 months of screening.
Subjects with evidence (clinical, laboratory, or imaging) or history of neoplasm, or, cancer recurrence within the past 5 years (other than non-melanoma skin cancer or in situ cervical carcinoma).
Have evidence of moderate to severe proliferative retinopathy on fundoscopic examination by an ophthalmologist.
History of severe aortic stenosis (aortic valve area \< 1.0 cm2) or insufficiency(\>2+); severe mitral stenosis (mitral valve area \<1.5 cm2); or severe mitral insufficiency(\>2+).
Coronary revascularization procedures within 6 months of study enrollment.
Documented stroke or transient ischemic attack (TIA) within 60 days of study enrollment.
Severe co-morbidity associated with a reduction in life expectancy of less than 1 year, such as chronic medical illness (i.e. severe chronic obstructive pulmonary disease, renal failure or cancer).
Joint or peripheral vascular disease that severely limit treadmill walking.
Chronic obstructive pulmonary disease that severely limits walking or FEV1.0\<30% predicted.
Have idiopathic or non-ischemic heart failure.
Have NYHA Class IV heart failure.
Have or require mechanical ventricular support
Had surgical heart failure treatments, including left ventricular reconstructive surgery (Dor procedure, cardiomyoplasty, LV banding, etc.)
Implantation of biventricular pacemaker within 90 days of study treatment.
Be pregnant or lactating.
Have a history of an allergy to penicillin.
Have sickle cell disease.
Have an untreatable coagulopathy.
Have a serum creatinine \>3.5 mg/dL.
Have any clinically significant abnormality in liver function or other clinical chemistry or hematology test (defined as a value more than 2 times the upper limit of the normal range for that value).
Previous enrollment in the study.
Be unsuitable for participation in the study, in the opinion of the Investigator.
