Both Exercise and Adenosine Stress Testing
- Conditions
- Coronary Artery Disease
- Registration Number
- NCT00200629
- Lead Sponsor
- Midwest Heart Foundation
- Brief Summary
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
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 200
- Female
- Age greater to or equal to 60 years old
- Must present with chest pain, fatigue, or other anginal equivalent symptoms
- Must be referred for stress testing based on clinical indications
- Must be able to provide written informed consent
- Women with known coronary artery disease (>50% lesion OR prior MI OR prior revascularization)
- Inability to perform any exercise on a treadmill
- Nuclear medicine study within the preceding 30 days
- Contraindication to adenosine, including moderate to severe COPD or asthma, second or third degree AV block, or known hypersensitivity to adenosine or aminophylline
- Left bundle branch block or electronic ventricular pacemaker
- Significant valvular heart disease
- Hemodynamic instability (blood pressure >210/110 ml/Hg or <90/60 mm/Hg)
- 2° or 3° atrioventricular block
- Symptomatic heart failure
- Ingestion of theophylline or dipyridamole within the preceding 48 hours
- Unavailability for follow-up
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Unstable angina requiring hospitalization non-fatal myocardial infarction death (cardiac and noncardiac) stroke performance of PCI or CABG if more than 1 month after initial evaluation hospitalization for heart failure after initial treatment is administered.
- Secondary Outcome Measures
Name Time Method Quality of Life measures (assessed by Duke Activity Status Index and Seattle Angina Questionnaire) at 6, 12, 18, and 24 months.
Trial Locations
- Locations (18)
Albany Associates in Cardiology
🇺🇸Albany, New York, United States
Jacksonville Heart Center, PA
🇺🇸Jacksonville Beach, Florida, United States
Cardiac Disease Specialists
🇺🇸Atlanta, Georgia, United States
Cardiovascular Consultants of Maine, PA
🇺🇸Scarborough, Maine, United States
Cardiology Consultants of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Southwest Heart
🇺🇸Tucson, Arizona, United States
Idaho Cardiology Associates
🇺🇸Meridian, Idaho, United States
North Shore University Hospital
🇺🇸Manhasset, New York, United States
Sacramento Heart & Vascular Research Center
🇺🇸Sacramento, California, United States
Diagnostic Cardiology, PA
🇺🇸Jacksonville, Florida, United States
Iowa Heart Center
🇺🇸Des Moines, Iowa, United States
Sutter Roseville Medical Center
🇺🇸Roseville, California, United States
Medical University of SC
🇺🇸Charleston, South Carolina, United States
Deaconess Medical Center
🇺🇸Spokane, Washington, United States
Delaware SPECT Imaging
🇺🇸Newark, Delaware, United States
Androscoggin Cardiology Associates
🇺🇸Auburn, Maine, United States
North Shore Cardiology
🇺🇸Bannockburn, Illinois, United States
Mid-Valley Cardiology
🇺🇸Kingston, New York, United States