Clinical trial NCT00200629: Both Exercise and Adenosine Stress Testing
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: Women
Diagnostic Testing
Radionuclide Imaging
Stress Testing
Adenosine
Lead sponsor: Midwest Heart Foundation
Sponsor class: OTHER
Collaborators: name: GE Healthcare
name: Astellas Pharma US, Inc.
First posted: 2005-09-20
Enrollment: 200
Sex: FEMALE
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Unstable angina requiring hospitalization
measure: non-fatal myocardial infarction
measure: death (cardiac and noncardiac)
measure: stroke
measure: performance of PCI or CABG if more than 1 month after initial evaluation
measure: hospitalization for heart failure after initial treatment is administered.
Secondary outcomes:
measure: Quality of Life measures (assessed by Duke Activity Status Index and Seattle Angina Questionnaire) at 6, 12, 18, and 24 months.
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Southwest Heart
state: Arizona
city: Roseville
country: United States
facility: Sutter Roseville Medical Center
state: California
city: Sacramento
country: United States
facility: Sacramento Heart & Vascular Research Center
state: California
city: Newark
country: United States
facility: Delaware SPECT Imaging
state: Delaware
city: Jacksonville Beach
country: United States
facility: Jacksonville Heart Center, PA
state: Florida
city: Jacksonville
country: United States
facility: Diagnostic Cardiology, PA
state: Florida
city: Atlanta
country: United States
facility: Cardiac Disease Specialists
state: Georgia
city: Boise
country: United States
facility: Idaho Cardiology Associates
state: Idaho
city: Meridian
country: United States
facility: Idaho Cardiology Associates
state: Idaho
city: Bannockburn
country: United States
facility: North Shore Cardiology
state: Illinois
city: Des Moines
country: United States
facility: Iowa Heart Center
state: Iowa
city: Auburn
country: United States
facility: Androscoggin Cardiology Associates
state: Maine
city: Scarborough
country: United States
facility: Cardiovascular Consultants of Maine, PA
state: Maine
city: Albany
country: United States
facility: Albany Associates in Cardiology
state: New York
city: Kingston
country: United States
facility: Mid-Valley Cardiology
state: New York
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
city: Philadelphia
country: United States
facility: Cardiology Consultants of Philadelphia
state: Pennsylvania
city: Philadelphia
country: United States
facility: Cardiology Consultants of Philadelphia
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of SC
state: South Carolina
city: Spokane
country: United States
facility: Deaconess Medical Center
state: Washington
Study officials:
affiliation: Midwest Heart Foundation
name: Robert Hendel, MD
role: PRINCIPAL_INVESTIGATOR
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