COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Both Exercise and Adenosine Stress Testing

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00200629
Recruitment Status : Terminated (Poor enrollment)
First Posted : September 20, 2005
Last Update Posted : August 9, 2011
GE Healthcare
Astellas Pharma US, Inc.
Information provided by:
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

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Procedure: Adenosine SPECT myocardial perfusion imaging Procedure: Combined adenosine / exercise SPECT myocardial perfusion imaging Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Study Start Date : June 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Adenosine

Primary Outcome Measures :
  1. Unstable angina requiring hospitalization
  2. non-fatal myocardial infarction
  3. death (cardiac and noncardiac)
  4. stroke
  5. performance of PCI or CABG if more than 1 month after initial evaluation
  6. hospitalization for heart failure after initial treatment is administered.

Secondary Outcome Measures :
  1. Quality of Life measures (assessed by Duke Activity Status Index and Seattle Angina Questionnaire) at 6, 12, 18, and 24 months.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00200629

Show Show 20 study locations
Sponsors and Collaborators
Midwest Heart Foundation
GE Healthcare
Astellas Pharma US, Inc.
Layout table for investigator information
Principal Investigator: Robert Hendel, MD Midwest Heart Foundation
Additional Information:
American Heart Association. 2002 Heart and Stroke Statistical Update. Dallas, Texas: American Heart Association; 2002.
Shaw LJ, Olson MB, Kelsey SF, et al. Using estimated functional capacity to optimize stress testing for diagnosis and prognosis of coronary artery disease in symptomatic women: Results from the NHLBI-sponsored Women Ischemia Syndrome Evaluation study., in preparation

Layout table for additonal information
Responsible Party: Kathleen Franke, Midwest Heart Foundation Identifier: NCT00200629    
Other Study ID Numbers: SPEC-BB
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: August 9, 2011
Last Verified: August 2011
Keywords provided by Midwest Heart Foundation:
Diagnostic Testing
Radionuclide Imaging
Stress Testing
Additional relevant MeSH terms:
Layout table for MeSH terms
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Vasodilator Agents
Purinergic P1 Receptor Agonists
Purinergic Agonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action