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

February 11, 2013 updated by: Cardium Therapeutics

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change in time to onset of ECG changes diagnostic of myocardial ischemia during ETT
Time Frame: Month 6
Month 6

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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
Month 6
Change in total exercise treadmill time
Time Frame: Months 3, 6 and 12
Months 3, 6 and 12
Change in time to onset ECG changes diagnostic myocardial ischemia during ETT
Time Frame: Months 3 and 12
Months 3 and 12
Change in time to onset of angina during ETT
Time Frame: Months 3, 6 and 12
Months 3, 6 and 12
Change in angina frequency and nitroglycerin
Time Frame: Months 3 and 6
Months 3 and 6
Change in patient functional status using CCS angina class
Time Frame: Months 3, 6 and 12
Months 3, 6 and 12
Change in rest and stress left ventricular ejection fraction assessed using gated SPECT
Time Frame: Month 6
Month 6
Change in quality of life using the Seattle Angina Questionnaire
Time Frame: Months 6 and 12
Months 6 and 12
Safety of Ad5FGF-4 as assessed by adverse events and clinical laboratory testing
Time Frame: Through month 12
Through month 12
Long-term safety of Ad5FGF-4 as assessed by clinically important events
Time Frame: Through month 60
Through month 60

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cardium Therapeutics

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Robert Engler, MD, Cardium Therapeutics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2007

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 21, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2007

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 22, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 13, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CT-3-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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