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Both Exercise and Adenosine Stress Testing

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

Status
Terminated
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00200629
Enrollment
200
Registered
2005-09-20
Start date
2005-06-30
Completion date
Unknown
Last updated
2011-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

Women, Diagnostic Testing, Radionuclide Imaging, Stress Testing, Adenosine

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.

Interventions

PROCEDUREAdenosine SPECT myocardial perfusion imaging
PROCEDURECombined adenosine / exercise SPECT myocardial perfusion imaging

Sponsors

GE Healthcare
CollaboratorINDUSTRY
Astellas Pharma US, Inc.
CollaboratorINDUSTRY
Midwest Heart Foundation
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
60 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
death (cardiac and noncardiac)
Unstable angina requiring hospitalization
non-fatal myocardial infarction
hospitalization for heart failure after initial treatment is administered.
stroke
performance of PCI or CABG if more than 1 month after initial evaluation

Secondary

MeasureTime frame
Quality of Life measures (assessed by Duke Activity Status Index and Seattle Angina Questionnaire) at 6, 12, 18, and 24 months.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026