Both Exercise and Adenosine Stress Testing

August 8, 2011 updated by: Midwest Heart Foundation

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85715
        • Southwest Heart
    • California
      • Roseville, California, United States, 95661-3037
        • Sutter Roseville Medical Center
      • Sacramento, California, United States, 95825
        • Sacramento Heart & Vascular Research Center
    • Delaware
      • Newark, Delaware, United States, 19713
        • Delaware SPECT Imaging
    • Florida
      • Jacksonville, Florida, United States, 32216
        • Diagnostic Cardiology, PA
      • Jacksonville Beach, Florida, United States, 32250
        • Jacksonville Heart Center, Pa
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Cardiac Disease Specialists
    • Idaho
      • Boise, Idaho, United States, 83704
        • Idaho Cardiology Associates
      • Meridian, Idaho, United States, 83704
        • Idaho Cardiology Associates
    • Illinois
      • Bannockburn, Illinois, United States, 60015
        • North Shore Cardiology
    • Iowa
      • Des Moines, Iowa, United States, 50314
        • Iowa Heart Center
    • Maine
      • Auburn, Maine, United States, 04210
        • Androscoggin Cardiology Associates
      • Scarborough, Maine, United States, 04074
        • Cardiovascular Consultants of Maine, PA
    • New York
      • Albany, New York, United States, 12212
        • Albany Associates In Cardiology
      • Kingston, New York, United States, 12401
        • Mid-Valley Cardiology
      • Manhasset, New York, United States, 11030
        • North Shore University Hospital
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19146
        • Cardiology Consultants of Philadelphia
      • Philadelphia, Pennsylvania, United States, 19148
        • Cardiology Consultants of Philadelphia
    • South Carolina
      • Charleston, South Carolina, United States, 29466
        • Medical University Of SC
    • Washington
      • Spokane, Washington, United States, 99204
        • Deaconess Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Midwest Heart Foundation

Collaborators

GE Healthcare
Astellas Pharma US, Inc.

Investigators

  • Principal Investigator: Robert Hendel, MD, Midwest Heart Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Estimate)

August 9, 2011

Last Update Submitted That Met QC Criteria

August 8, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPEC-BB

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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