Angiogenesis in Women With Angina Pectoris Who Are Not Candidates for Revascularization
NCT ID: NCT00438867
Last Updated: 2013-02-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
300 participants
INTERVENTIONAL
2007-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
Ad5FGF-4
Adenovirus serotype-5 mediated human fibroblast growth factor-4 gene transfer
2
Ad5FGF-4
Adenovirus serotype-5 mediated human fibroblast growth factor-4 gene transfer
3
Placebo
Control group
Interventions
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Ad5FGF-4
Adenovirus serotype-5 mediated human fibroblast growth factor-4 gene transfer
Placebo
Control group
Eligibility Criteria
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Inclusion Criteria
* 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;
1. ECG changes diagnostic of myocardial ischemia occur during the first 10 minutes of exercise
2. 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 Criteria
* 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
18 Years
75 Years
FEMALE
No
Sponsors
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Cardium Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Robert Engler, MD
Role: STUDY_DIRECTOR
Cardium Therapeutics
Locations
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University of Alabama
Birmingham, Alabama, United States
Banner Heart Hospital
Phoenix, Arizona, United States
Southwest Heart
Tucson, Arizona, United States
Access Clinical Trials
Beverly Hills, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Mission Internal Medical Group
Mission Viejo, California, United States
UCSD Medical Center
San Diego, California, United States
Aurora Denver Cardiology
Aurora, Colorado, United States
South Denver Cardiology
Littleton, Colorado, United States
Cardiovascular Research Institute
Washington D.C., District of Columbia, United States
University of Florida
Gainesville, Florida, United States
Florida Hospital
Orlando, Florida, United States
St Joseph's Research Institute
Atlanta, Georgia, United States
St. Luke's Idaho Cardiology Associates
Boise, Idaho, United States
Fox Valley Cardiovascular Consultants
Aurora, Illinois, United States
Midwest Heart Foundation
Lombard, Illinois, United States
Northern Indiana Research Alliance
Fort Wayne, Indiana, United States
The Care Group
Indianapolis, Indiana, United States
Cardiovascular Associates
Louisville, Kentucky, United States
Maine Medical Center
Portland, Maine, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Michigan Medical Center
Ann Arbor, Michigan, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
St. Mary's Duluth Clinic
Duluth, Minnesota, United States
Minneapolis Heart Institute
Minneapolis, Minnesota, United States
Mid America Heart Institute
Kansas City, Missouri, United States
St. Anthony's Medical Center
St Louis, Missouri, United States
BryanLGH Heart Institute
Lincoln, Nebraska, United States
Creighton University
Omaha, Nebraska, United States
The Valley Hospital
Ridgewood, New Jersey, United States
Lenox Hill Heart & Vascular Institute
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
The Lindner Clinical Trial Center
Cincinnati, Ohio, United States
North Ohio Heart Center
Elyria, Ohio, United States
Oklahoma Cardiovascular Associates
Oklahoma City, Oklahoma, United States
Providence Heart & Vascular Institute
Portland, Oregon, United States
Heritage Cardiology Associates
Camp Hill, Pennsylvania, United States
Geisinger Clinic
Danville, Pennsylvania, United States
The Miriam Hospital
Providence, Rhode Island, United States
The Stern Cardiovascular Center
Germantown, Tennessee, United States
Meharry Medical College
Nashville, Tennessee, United States
Baylor University Medical Center at Dallas
Dallas, Texas, United States
South Texas Cardiovascular Consultants
San Antonio, Texas, United States
Cardiovascular Associates of East Texas
Tyler, Texas, United States
Fletcher Allen Health Care
Burlington, Vermont, United States
Swedish Medical Center
Seattle, Washington, United States
Care Foundation
Wausau, Wisconsin, United States
Countries
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References
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Henry TD, Grines CL, Watkins MW, Dib N, Barbeau G, Moreadith R, Andrasfay T, Engler RL. Effects of Ad5FGF-4 in patients with angina: an analysis of pooled data from the AGENT-3 and AGENT-4 trials. J Am Coll Cardiol. 2007 Sep 11;50(11):1038-46. doi: 10.1016/j.jacc.2007.06.010. Epub 2007 Aug 24.
Other Identifiers
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CT-3-001
Identifier Type: -
Identifier Source: org_study_id
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