ACORD Trial, Rush University Medical Center, Chicago, IL

Treatment for no-option heart patients with coronary artery disease via injections (10) into the heart with a human recombinant (protein) fibroblast growth factor (FGF- investigational compound) compared to placebo. The treatment will be assigned randomly. The goal is to stimulate the growth of new blood vessels around blocked coronary arteries.

The objectives of this research includes evaluating the safety and tolerability of human FGF-1 administered by intramyocardial catheter injection in no-option CHD subjects, to evaluate a range of doses of FGF-1 to determine which dose will be carried forward to the next trial, to evaluate the effects of FGF-1 versus placebo dose on changes in: 1) cardiac perfusion 2) exercise performance and 3) reduction in angina. This is an international trial and approximately 200 subjects are expected to be recruited. At Rush University Medical Center, we expect to enroll 6-10 patients.

All subjects who meet the entry criteria will undergo a series of screening assessments. Target areas for revascularization will be selected based on the treating cardiologist's examination of SPECT perfusion results. Those segments which exhibit hypoperfusion will be targeted for treatment. It is planned that the total dose of product will be administered to ischemic areas of the heart wall via 10 catheter injections of approximately 0.3 mL volume for each injection. Subjects will be followed for 52 weeks after the treatment.

You may be eligible for this study if you:

Are between 25 and 75 years of age
Have had at least a three-month history of chronic stable angina that is documented as triggered by physical effort, and is relieved by rest and/or nitroglycerin
Have been told that you are not suitable for PCTA or CABG by your treating cardiologist
Are on optimal medical therapy for at least two months prior to entering the study; and are on at least one of the following medications: beta-blockers, calcium entry blockers, ranolazine, or long-acting nitrates
Have a left ventricular ejection fraction (LVEF) of 30 percent or greater

You are not eligible for this study if you:

Have a history of CABG, angioplasty, transmyocardial revascularization, or acute myocardial infarction in the last three months
Have a history of any cancer (except past history of basal cell carcinoma of the skin)
Have a permanent pacemaker
Have had a heart transplant, or aortic valve transplant, or mitral valve transplant
Cannot perform an Exercise Treadmill Test for any reason
Require dialysis

This is a partial list of eligibility and exclusion criteria. To determine if you are eligible to participate, please call the contact phone number provided. If you choose to respond by e-mail, please refer to the title of the study in your correspondence.