Angiogenesis in Women With Angina Pectoris Who Are Not Candidates for Revascularization (AWARE)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2008 by Cardium Therapeutics.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Cardium Therapeutics
ClinicalTrials.gov Identifier:
NCT00438867
First received: February 21, 2007
Last updated: February 11, 2013
Last verified: November 2008
  Purpose

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 and improving myocardial blood flow as measured by SPECT imaging. Exercise capacity, angina functional class, patient symptoms and quality of life will also be evaluated to characterize the efficacy of Ad5FGF-4. Short-term and long-term safety of Ad5FGF-4 will also be evaluated.


Condition Intervention Phase
Angina Pectoris
Genetic: Ad5FGF-4
Genetic: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double Blind, Placebo Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Ad5FGF-4 in Female Patients With Stable Angina Pectoris Who Are Not Candidates for Revascularization

Resource links provided by NLM:


Further study details as provided by Cardium Therapeutics:

Primary Outcome Measures:
  • Change in time to onset of ECG changes diagnostic of myocardial ischemia during ETT [ Time Frame: Month 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in reversible perfusion defect size as measured by adenosine single-photon emission computed tomography with technetium-99m sestamibi (SPECT)(principal secondary endpoint) [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
  • Change in total exercise treadmill time [ Time Frame: Months 3, 6 and 12 ] [ Designated as safety issue: No ]
  • Change in time to onset ECG changes diagnostic myocardial ischemia during ETT [ Time Frame: Months 3 and 12 ] [ Designated as safety issue: No ]
  • Change in time to onset of angina during ETT [ Time Frame: Months 3, 6 and 12 ] [ Designated as safety issue: No ]
  • Change in angina frequency and nitroglycerin [ Time Frame: Months 3 and 6 ] [ Designated as safety issue: No ]
  • Change in patient functional status using CCS angina class [ Time Frame: Months 3, 6 and 12 ] [ Designated as safety issue: No ]
  • Change in rest and stress left ventricular ejection fraction assessed using gated SPECT [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
  • Change in quality of life using the Seattle Angina Questionnaire [ Time Frame: Months 6 and 12 ] [ Designated as safety issue: No ]
  • Safety of Ad5FGF-4 as assessed by adverse events and clinical laboratory testing [ Time Frame: Through month 12 ] [ Designated as safety issue: Yes ]
  • Long-term safety of Ad5FGF-4 as assessed by clinically important events [ Time Frame: Through month 60 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: May 2007
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Genetic: Ad5FGF-4
Adenovirus serotype-5 mediated human fibroblast growth factor-4 gene transfer
Experimental: 2 Genetic: Ad5FGF-4
Adenovirus serotype-5 mediated human fibroblast growth factor-4 gene transfer
Placebo Comparator: 3 Genetic: Placebo
Control group

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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;

    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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00438867

  Hide Study Locations
Locations
United States, Alabama
University of Alabama
Birmingham, Alabama, United States, 35294
United States, Arizona
Banner Heart Hospital
Phoenix, Arizona, United States, 85206
Southwest Heart
Tucson, Arizona, United States, 85715
United States, California
Access Clinical Trials
Beverly Hills, California, United States, 90210
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Mission Internal Medical Group
Mission Viejo, California, United States, 92691
UCSD Medical Center
San Diego, California, United States, 92103
United States, Colorado
Aurora Denver Cardiology
Aurora, Colorado, United States, 80012
South Denver Cardiology
Littleton, Colorado, United States, 80120
United States, District of Columbia
Cardiovascular Research Institute
Washington, District of Columbia, United States, 20010
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
Florida Hospital
Orlando, Florida, United States, 32803
United States, Georgia
St Joseph's Research Institute
Atlanta, Georgia, United States, 30342
United States, Idaho
St. Luke's Idaho Cardiology Associates
Boise, Idaho, United States, 83712
United States, Illinois
Fox Valley Cardiovascular Consultants
Aurora, Illinois, United States, 60504
Midwest Heart Foundation
Lombard, Illinois, United States, 60148
United States, Indiana
Northern Indiana Research Alliance
Fort Wayne, Indiana, United States, 46804
The Care Group
Indianapolis, Indiana, United States, 46290
United States, Kentucky
Cardiovascular Associates
Louisville, Kentucky, United States, 40205
United States, Maine
Maine Medical Center
Portland, Maine, United States, 04102
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Michigan
University of Michigan Medical Center
Ann Arbor, Michigan, United States, 48109
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
United States, Minnesota
St. Mary's Duluth Clinic
Duluth, Minnesota, United States, 55805
Minneapolis Heart Institute
Minneapolis, Minnesota, United States, 55407
United States, Missouri
Mid America Heart Institute
Kansas City, Missouri, United States, 64111
St. Anthony's Medical Center
St. Louis, Missouri, United States, 63128
United States, Nebraska
BryanLGH Heart Institute
Lincoln, Nebraska, United States, 68506
Creighton University
Omaha, Nebraska, United States, 68131
United States, New Jersey
The Valley Hospital
Ridgewood, New Jersey, United States, 07450
United States, New York
Lenox Hill Heart & Vascular Institute
New York, New York, United States, 10021
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
The Lindner Clinical Trial Center
Cincinnati, Ohio, United States, 45219
North Ohio Heart Center
Elyria, Ohio, United States, 44035
United States, Oklahoma
Oklahoma Cardiovascular Associates
Oklahoma City, Oklahoma, United States, 73109
United States, Oregon
Providence Heart & Vascular Institute
Portland, Oregon, United States, 97225
United States, Pennsylvania
Heritage Cardiology Associates
Camp Hill, Pennsylvania, United States, 17011
Geisinger Clinic
Danville, Pennsylvania, United States, 17822
United States, Rhode Island
The Miriam Hospital
Providence, Rhode Island, United States, 02906
United States, Tennessee
The Stern Cardiovascular Center
Germantown, Tennessee, United States, 38138
Meharry Medical College
Nashville, Tennessee, United States, 37208
United States, Texas
Baylor University Medical Center at Dallas
Dallas, Texas, United States, 75226
South Texas Cardiovascular Consultants
San Antonio, Texas, United States, 78229
Cardiovascular Associates of East Texas
Tyler, Texas, United States, 75701
United States, Vermont
Fletcher Allen Health Care
Burlington, Vermont, United States, 05401
United States, Washington
Swedish Medical Center
Seattle, Washington, United States, 98122
United States, Wisconsin
Care Foundation
Wausau, Wisconsin, United States, 54401
Sponsors and Collaborators
Cardium Therapeutics
Investigators
Study Director: Robert Engler, MD Cardium Therapeutics
  More Information

No publications provided by Cardium Therapeutics

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cardium Therapeutics
ClinicalTrials.gov Identifier: NCT00438867     History of Changes
Other Study ID Numbers: CT-3-001
Study First Received: February 21, 2007
Last Updated: February 11, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Cardium Therapeutics:
angina
FGF-4
angiogenesis
growth factor
myocardia ischemia
revascularization

Additional relevant MeSH terms:
Angina Pectoris
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on July 22, 2014