Cardium Therapeutics: AWARE Clinical Trial

View AWARE
Study Website

CLINICAL DEVELOPMENT: AWARE CLINICAL STUDY

Purpose
The Phase 3 AWARE trial will study the effects of Generx™ (Ad5FGF-4) in women for the potential treatment of myocardial ischemia (insufficient blood flow within the heart muscle) which gives rise to angina associated with coronary heart disease. Generx is an investigational product designed to promote angiogenesis, a natural process of blood vessel growth within the heart muscle.
Study Design
AWARE (Angiogenesis in Women with Angina pectoris who are not candidates for Revascularization) is a randomized, placebo-controlled, double-blind safety and efficacy study to evaluate a one-time intracoronary administration of Generx. The AWARE study is enrolling approximately 300 women with recurrent stable angina pectoris who are not candidates for revascularization and who are receiving optimal drug therapy. Approximately 50 U.S. medical centers are expected to participate in the AWARE study.
Primary and Secondary Measures
The primary endpoint will be the improvement in time to onset of electrocardiogram changes diagnostic of myocardial ischemia during exercise treadmill testing at six months following administration. The secondary endpoints will include improvement in myocardial blood flow within the affected heart muscle measured by adenosine SPECT (single photon emission computed tomography) imaging, as well as improvements in other measures of angina.
Eligibility

Female patients 18-75 years of age inclusive with stable angina classified as CCS III or IV,
Women who can complete an exercise treadmill test,
Receiving treatment with at least two classes of chronic anti-anginal medication, of which two are at the maximally tolerated dose, and
Not a candidate for, or unlikely to benefit from standard revascularization (angioplasty or bypass surgery) procedures.

Locations and Contact Information
For additional information about the AWARE clinical study and enrollment information please visit http://www.clinicaltrials.gov/ct/show/ NCT00438867, call Tony Andrasfay at 858-436-1014 or email at tandrasfay@cardiumthx.com, or contact the clinical site in your area. Please refer to this study by its ClinicalTrials.gov identifier NCT00438867.

United States, Alabama

University of Alabama
Recruiting
Birmingham, Alabama, United States, 35294
Contact: Joan Harshberger jharshberger@cardmail.dom.uab.edu

United States, Arizona

Banner Heart Hospital
Recruiting
Phoenix, Arizona, United States, 85206
Contact: Sheryn Budge sheryn.budge@bannerhealth.com
Contact: Tina Schaffner tina.schaffner@bannerhealth.com

Southwest Heart
Not yet recruiting
Tucson, Arizona, United States, 85715
Contact: Ken Peart kenp@swheart.com

United States, California

UCSD Medical Center
Not yet recruiting
San Diego, California, United States, 92103
Contact: Cecilia Judd cjudd@ucsd.edu

Mission Internal Medical Group
Recruiting
Mission Viejo, California, United States, 92691
Contact: Rhodora Enriquez renriquez@mimg.com

Access Clinical Trials
Recruiting
Beverly Hills, California, United States, 90210
Contact: Tracey Gerez traceyg@cvmg.com

Cedars-Sinai Medical Center, United States
Recruiting
Los Angeles, California, United States, 90048
Contact: Linn Defensor defensor@cshs.org

LA Cardiology
Not yet recruiting
Los Angeles, California, United States, 90017
Contact: Cecile Mayoralgo cmayoral@lacard.com

United States, Colorado

Aurora Denver Cardiology
Recruiting
Aurora, Colorado, United States, 80012
Contact: Stephanie West swest@adcacardiology.com

South Denver Cardiology
Not yet recruiting
Littleton, Colorado, United States, 80120
Contact: Delsa Rose drose@southdenver.com

United States, District of Columbia, United States

Cardiovascular Research Institute
Recruiting
Washington, District of Columbia, United States, 20010
Contact: Suman Singh sumandoc007@hotmail.com

United States, Florida

Florida Hospital
Recruiting
Orlando, Florida, United States, 32803
Contact: Leann Goodwin leann.goodwin@flhosp.org

University of Florida
Recruiting
Gainesville, Florida, United States, 32610
Contact: Tempa Curry currytj@medicine.ufl.edu

United States, Georgia

St Joseph's Research Institute
Recruiting
Atlanta, Georgia, United States, 30342
Contact: Kristie Stricker kstricker@sjha.org

United States, Idaho

St. Luke's Idaho Cardiology Associates
Recruiting
Boise, Idaho, United States, 83712
Contact: Vicki Graves vickig@idahocardiology.com

United States, Illinois

Fox Valley Cardiovascular Consultants
Recruiting
Aurora, Illinois, United States, 60504
Contact: Ann Perkins aperkins@foxvalleycardio.com

Midwest Heart Foundation
Not yet recruiting
Lombard, Illinois, United States, 60148
Contact: Lea Elder lelder@midwestheart.org

United States, Indiana

The Care Group
Recruiting
Indianapolis, Indiana, United States, 46290
Contact: Anne Taylor ataylor@thecaregroup.com

Northern Indiana Research Alliance
Recruiting
Fort Wayne, Indiana, United States, 46804
Contact: Terri Park tpark@hcmgmail.com

United States, Kentucky

Cardiovascular Associates
Recruiting
Louisville, Kentucky, United States, 40205
Contact: Andrea Geary ageary@cvaky.com
Contact: Julie Hanrahan jhanrahan@cvaky.com

United States, Maine

Maine Medical Center
Recruiting
Portland, Maine, United States, 04102
Contact: Joanne Burgess burgejs@mmc.org

United States, Massachusetts

Massachusetts General Hospital
Recruiting
Boston, Massachusetts, United States, 02114
Contact: Voula Christopoulos vchristopoulos1@partners.org

United States, Michigan

William Beaumont Hospital
Not yet recruiting
Royal Oak, Michigan, United States, 48073
Contact: Diedre Brunk diedre.brunk@beaumonthospitals.com

United States, Minnesota

Minneapolis Heart Institute
Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Denise Windenburg denise.c.windenburg@allina.com

St. Mary's Duluth Clinic
Recruiting
Duluth, Minnesota, United States, 55805
Contact: Peggy Lipinski plipinski@smdc.org

United States, Missouri

Mid America Heart Institute
Recruiting
Kansas City, Missouri, United States, 64111
Contact: Katie Safley ksafley@saint-lukes.org

St. Anthony's Medical Center
Recruiting
St. Louis, Missouri, United States, 63128
Contact: Carol Mechem carol.mechem@samcstl.com

United States, Nebraska

Creighton University
Recruiting
Omaha, Nebraska, United States, 68131
Contact: Eddy Butkus eddy.butkus@cardiac.creighton.edu

BryanLGH Heart Institute
Recruiting
Lincoln, Nebraska, United States, 68506
Contact: Cheryl Orosco cherylo@bhi-1.com

United States, New Jersey

The Valley Hospital
Recruiting
Ridgewood, New Jersey, United States, 07450
Contact: Jacqueline Backhaus jbackha@valleyhealth.com

United States, New York

Lenox Hill Heart & Vascular Institute
Not yet recruiting
New York, New York, United States, 10021
Contact: Christina Brennan, MD cbrennan@lenoxhill.net

University of Rochester Medical Center
Not yet recruiting
Rochester, New York, United States, 14642
Contact: Lori Caufield lori_caufield@urmc.rochester.edu

United States, North Carolina

Duke University Medical Center
Not yet recruiting
Durham, North Carolina, United States, 27710
Contact: Sophie Wang sophie.wang@duke.edu

United States, Ohio

The Lindner Clinical Trial Center
Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Darlene Rock rock.lctc@fuse.net

North Ohio Heart Center
Not yet recruiting
Elyria, Ohio, United States, 44035
Contact: Amy Giunta agiunta@nohc.com

United States, Oklahoma

Oklahoma Cardiovascular Associates
Recruiting
Oklahoma City, Oklahoma, United States, 73109
Contact: Kay Springer kspringer@ocaheart.com

United States, Oregon

Providence Heart & Vascular Institute
Recruiting
Portland, Oregon, United States, 97225
Contact: Eric Johnson eric.johnson@providence.org

United States, Pennsylvania

Geisinger Clinic
Recruiting
Danville, Pennsylvania, United States, 17822
Contact: Deborah Zimmerman dkzimmerman@geisinger.edu

Heritage Cardiology Associates
Recruiting
Camp Hill, Pennsylvania, United States, 17011
Contact: Kim Darrow kdarrow@heritagemedgrp.com

United States, Rhode Island

The Miriam Hospital
Not yet recruiting
Providence, Rhode Island, United States, 02906
Contact: Lori-Ann DeSimone ldesimone@lifespan.org

United States, Tennessee

Meharry Medical College
Not yet recruiting
Nashville, Tennessee, United States, 37208
Contact: Mindy White whitem@mmc.edu

The Stern Cardiovascular Center
Recruiting
Germantown, Tennessee, United States, 38138
Contact: Barbara Hamilton barbara.hamilton@sterncardio.com

United States, Texas

Cardiovascular Associates of East Texas
Recruiting
Tyler, Texas, United States, 75701
Contact: James Crump jcrump@caet.net

South Texas Cardiovascular Consultants
Recruiting
San Antonio, Texas, United States, 78229
Contact: Jodie Addington jaddington@heartdoctors.net

Ben Taub General Hospital
Not yet recruiting
Houston, Texas, United States, 77030
Contact: Jaromir Bobek jbobek@bcm.tmc.edu

United States, Vermont

Fletcher Allen Health Care
Recruiting
Burlington, Vermont, United States, 05401
Contact: Linda Chadwick linda.chadwick@vtmednet.org

United States, Washington

Swedish Medical Center
Recruiting
Seattle, Washington, United States, 98122
Contact: Colleen Truva colleen.truva@swedish.org
Contact: Inger Rasmussen inger.rasmussen@swedish.org

United States, Wisconsin

Care Foundation
Recruiting
Wausau, Wisconsin, United States, 54401
Contact: Karen Olson kareno@carefoundation.org

Sponsors and Collaborators
Cardium Therapeutics

Investigators
Study Director:
Randall Moreadith, MD, PhD
Cardium Therapeutics