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Sponsors and Collaborators: |
Midwest Heart Foundation GE Healthcare Astellas Pharma US, Inc. |
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Information provided by: | Midwest Heart Foundation |
ClinicalTrials.gov Identifier: | NCT00200629 |
The purpose of this study is to compare the 2-year cardiac outcomes for women with limited exercise capability based on the resuls of either pharmacological stress myocardial perfusion imaging or a combined protocol that incorporates both exercise and pharmacological stress. The goal of the study is to compare these two methods for patient tolerability, safety and prognostic value
Condition | Intervention | Phase |
---|---|---|
Coronary Artery Disease |
Procedure: Adenosine SPECT myocardial perfusion imaging Procedure: Combined adenosine / exercise SPECT myocardial perfusion imaging |
Phase IV |
Study Type: | Interventional |
Study Design: | Diagnostic, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | A Pilot Study Examining the Value of Combined Exercise and Adenosine Stress Myocardial Perfusion Imaging as Compared With Adenosine Testing Alone for the Evaluation of Women at Intermediate or High Likelihood for Coronary Artery Disease |
Estimated Enrollment: | 200 |
Study Start Date: | June 2005 |
Coronary artery disease remains the leading cause of morbidity and mortality in women accounting for more than 250,000 deaths per year. Despite the high prevalence in ischemic heart disease in women, most clinical trials have focused on male cohorts. The optimal non-invasive test for evaluation of ischemic heart disease in women is unknown. A number of different modalities have been employed including exercise ECG stress testing, 2-dimensional stress echocardiography, SPECT myocardial perfusion imaging, and electron beam computerized tomography.
The cohort of women for whom to perform testing upon is also ill-defined. Myocardial perfusion imaging, in conjunction with pharmacologic stress testing, has also been shown to be effective in the diagnosis of women with known or suspected coronary artery disease as well as in for risk stratification. Recently, pharmacologic stress has been combined with low-level exercise, enhancing test tolerability and SPECT perfusion image quality. Furthermore, the use of a combined adenosine and exercise protocol may detect greater amounts of ischemia with perfusion imaging that with an exercise test alone. Therefore, in women who may be unable to perform maximal exercise, this combined pharmacologic and exercise imaging protocol may possess a significant advantage over adenosine stress testing alone.
The aim of this study is to compare safety and symptoms associated with these two methods of stress testing. The current study also seeks to establish the optimal method for detection of coronary artery disease in women who have a limited capacity for exercise (DASI score ≤5 METS), also well as examine the prognostic value of each method of testing by comparing the two-year event rates for women who undergo adenosine SPECT imaging or SPECT imaging using adenosine with adjunctive exercise.
Ages Eligible for Study: | 60 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Kathleen Korrigan, RN, CCRC | 617-423-7999 ext 124 | kcorrigan@ccstrials.com |
Contact: Patricia M Wedge, RN, CCRC | 617-423-7999 ext 118 | pwedge@ccstrials.com |
United States, Arizona | |
Southwest Heart | Recruiting |
Tucson, Arizona, United States, 85715 | |
Contact: Ken Peart | |
Principal Investigator: Brenda Peart | |
United States, California | |
Sacramento Heart & Vascular Research Center | Recruiting |
Sacramento, California, United States, 95825 | |
Contact: Deborah Homes 916-830-2044 ext 7 | |
Principal Investigator: Raye Bellinger | |
Sutter Roseville Medical Center | Recruiting |
Roseville, California, United States, 95661-3037 | |
Contact: Michelle Rouquet 916-781-1474 | |
Principal Investigator: Frederick Weiland | |
United States, Delaware | |
Delaware SPECT Imaging | Recruiting |
Newark, Delaware, United States, 19713 | |
Contact: Colleen Buchanan 610-268-0597 | |
Principal Investigator: Steven Edell | |
United States, Florida | |
Jacksonville Heart Center, PA | Recruiting |
Jacksonville Beach, Florida, United States, 32250 | |
Contact: Jill DePauw 904-339-0037 | |
Principal Investigator: Pamela Ramos Rama | |
Diagnostic Cardiology, PA | Recruiting |
Jacksonville, Florida, United States, 32216 | |
Contact: Melody Thompson 904-296-0278 | |
Principal Investigator: William Short | |
United States, Georgia | |
Cardiac Disease Specialists | Recruiting |
Atlanta, Georgia, United States, 30309 | |
Contact: Stephanie Cadsawan 404-355-9815 ext 235 | |
Principal Investigator: Sally Beer, MD | |
United States, Idaho | |
Idaho Cardiology Associates | Recruiting |
Meridian, Idaho, United States, 83704 | |
Contact: Kathy Curry 208-685-2213 | |
Principal Investigator: Andrew Chai | |
Idaho Cardiology Associates | Recruiting |
Boise, Idaho, United States, 83704 | |
Contact: Kathy Curry 208-685-2213 | |
Principal Investigator: David Hinchman | |
United States, Illinois | |
North Shore Cardiology | Recruiting |
Bannockburn, Illinois, United States, 60015 | |
Contact: Lynn Steckel 847-444-5340 | |
Contact: Eleonora Mitova 847-444-5340 | |
Principal Investigator: Jay Alexander, MD | |
United States, Iowa | |
Iowa Heart Center | Recruiting |
Des Moines, Iowa, United States, 50314 | |
Contact: Deb French 515-633-3844 | |
Principal Investigator: Margaret Verhey | |
United States, Maine | |
Cardiovascular Consultants of Maine, PA | Recruiting |
Scarborough, Maine, United States, 04074 | |
Contact: Brenda Glasgow 207-782-9835 ext 3608 | |
Principal Investigator: Craig Brett | |
Androscoggin Cardiology Associates | Recruiting |
Auburn, Maine, United States, 04210 | |
Contact: Michelle Bergeron | |
Principal Investigator: Dervilla McCann | |
United States, New York | |
Mid-Valley Cardiology | Recruiting |
Kingston, New York, United States, 12401 | |
Contact: Martha Meyer 845-331-6600 ext 107 | |
Principal Investigator: Ellis Lader | |
North Shore University Hospital | Recruiting |
Manhasset, New York, United States, 11030 | |
Contact: Diane Redmond 516-562-2653 | |
Principal Investigator: Jennifer Mieres | |
Albany Associates in Cardiology | Recruiting |
Albany, New York, United States, 12212 | |
Contact: Sandra Preston 518-435-2759 | |
Principal Investigator: David Wolinsky | |
United States, Pennsylvania | |
Cardiology Consultants of Philadelphia | Recruiting |
Philadelphia, Pennsylvania, United States, 19148 | |
Contact: Trish McNeilis 215-339-0541 | |
Principal Investigator: Veronica Covalesky | |
Cardiology Consultants of Philadelphia | Recruiting |
Philadelphia, Pennsylvania, United States, 19146 | |
Contact: Trish McNeilis 215-893-8021 | |
Principal Investigator: Santosh Gupta-Bala | |
United States, South Carolina | |
Medical University of SC | Recruiting |
Charleston, South Carolina, United States, 29466 | |
Contact: Michelle Burke 843-792-1957 | |
Principal Investigator: Leonie Gordon | |
United States, Washington | |
Deaconess Medical Center | Recruiting |
Spokane, Washington, United States, 99204 | |
Contact: Monica Pounder 509-473-3480 | |
Principal Investigator: Janice Christensen |
Principal Investigator: | Robert Hendel, MD | Midwest Heart Foundation |
Study ID Numbers: | SPEC-BB |
Study First Received: | September 12, 2005 |
Last Updated: | February 16, 2006 |
ClinicalTrials.gov Identifier: | NCT00200629 |
Health Authority: | United States: Food and Drug Administration |
Women Diagnostic Testing Radionuclide Imaging Stress Testing Adenosine |
Arterial Occlusive Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases |
Stress Arteriosclerosis Ischemia Adenosine Coronary Artery Disease |
Vasodilator Agents Sensory System Agents Therapeutic Uses Physiological Effects of Drugs Cardiovascular Diseases Cardiovascular Agents |
Anti-Arrhythmia Agents Peripheral Nervous System Agents Analgesics Central Nervous System Agents Pharmacologic Actions |