Status:
UNKNOWN
Angiogenesis in Women With Angina Pectoris Who Are Not Candidates for Revascularization
Lead Sponsor:
Cardium Therapeutics
Conditions:
Angina Pectoris
Eligibility:
FEMALE
18-75 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine whether a one-time intracoronary infusion of Ad5FGF-4 is effective in reducing the time to onset myocardial ischemia as measured by exercise treadmill testing...
Eligibility Criteria
Inclusion
- Female patients 18-75 years of age inclusive
- Stable angina classified as CCS III or IV
- Receiving treatment with at least two classes of chronic anti-anginal medication, of which two are at the maximally tolerated dose
- Left ventricular ejection fraction (LVEF) of ≥30%
- Not a candidate for, or unlikely to benefit from standard revascularization procedures as verified by an independent cardiologist or cardiothoracic surgeon (not a study investigator) at each center
- Can undergo ETT using the modified Bruce protocol and;
- ECG changes diagnostic of myocardial ischemia occur during the first 10 minutes of exercise
- Variability of the time to onset of ECG changes diagnostic of myocardial ischemia is ≤25% or within 60 seconds if the time to onset of myocardial ischemia occurs within the first 4 minutes of exercise as determined by two consecutive screening treadmill tests
- Evidence of stress induced myocardial ischemia by adenosine SPECT, defined as a reversible perfusion defect size of ≥9%
- Willing and able to comply with the study requirements including long-term follow-up
- Provided written informed consent
Exclusion
- Patients of childbearing potential (must be surgically sterile or post-menopausal)
- Patients for whom an immediate revascularization procedure is indicated (CABG surgery or PCI)
- Myocardial infarction within the past 3 months
- Unstable angina or hospitalization requiring intravenous anti-anginal therapy within the 14 days prior to the start of screening evaluations
- Congestive heart failure NYHA Class IV
- Electrocardiogram that precludes accurate assessment of exercise induced myocardial ischemia (e.g., left bundle branch block, Wolf-Parkinson-White syndrome, atrial fibrillation)
- Myocarditis or restrictive pericarditis
- Left main coronary stenosis ≥70% (unless the patient has a patent graft or collateral vessels supplying the left coronary circulation) or proximal stenoses ≥70% in all major coronary conduit vessels (coronary arteries and bypass grafts)
- Clinically significant aortic or mitral valvular heart disease
- Coronary ostial stenosis that precludes adequate catheter engagement in any target vessel
- Coronary artery to venous communications, which bypass the coronary capillary bed
- Untreated life-threatening ventricular arrhythmias
- CABG surgery within the past 6 months, unless those grafts are now occluded.
- Percutaneous transluminal angioplasty (PTCA) within the past 3 months, unless the dilated vessel(s) are now occluded
- Enhanced external counterpulsation (EECP) within 3 months prior to the start of screening evaluations
- Transmyocardial or percutaneous myocardial laser revascularization within the previous year
- Prior treatment with any cardiovascular gene or stem cell therapy.
- Any intercurrent illness that may interfere with their ability to perform a maximal ETT
- Any major organ disease that substantially impairs life expectancy.
- History of cancer, other than basal cell carcinoma, or patients with any laboratory or physical exam or diagnostic procedure finding suggestive of current malignancy
- Moderate to severe nonproliferative or proliferative retinopathy from any cause (ETDRS score \>35), clinically significant macular edema, or previous panretinal photocoagulation therapy
- Heparin induced thrombocytopenia or history of idiopathic thrombocytopenic purpura or other medical condition causing thrombocytopenia
- SGPT level greater than 2.0 times the upper limit of the laboratory normal range
- Bilirubin level ≥2.0 mg/dL
- Serum creatinine ≥2.5 mg/dL
- Platelet count \<100,000/μL
- White blood cell count \<3,000/μL
- Positive test for hepatitis B or C
- Positive test for HIV
- History of colon cancer in a first degree relative (i.e., parent, sibling or offspring) unless the patient has undergone a colonoscopy in the past 36 months with negative findings
- History of breast cancer in a first degree relative
- Patient in a family with any documented hereditary cancer syndrome
- Prior anaphylaxis reaction to iodinated contrast agents
- Patients who are known to be immunosuppressed or are receiving chronic treatment with immunosuppressive drugs
- Received an investigational drug or biologic within 30 days of screening or are currently participating in an investigational drug, biologic or device trial
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00438867
Start Date
May 1 2007
Last Update
February 13 2013
Active Locations (47)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Alabama
Birmingham, Alabama, United States, 35294
2
Banner Heart Hospital
Phoenix, Arizona, United States, 85206
3
Southwest Heart
Tucson, Arizona, United States, 85715
4
Access Clinical Trials
Beverly Hills, California, United States, 90210