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Both Exercise and Adenosine Stress Testing

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ClinicalTrials.gov Identifier: NCT00200629
Recruitment Status : Terminated (Poor enrollment)
First Posted : September 20, 2005
Last Update Posted : August 9, 2011
Sponsor:
Collaborators:
GE Healthcare
Astellas Pharma US, Inc.
Information provided by:
Midwest Heart Foundation

Tracking Information
First Submitted Date  ICMJE September 12, 2005
First Posted Date  ICMJE September 20, 2005
Last Update Posted Date August 9, 2011
Study Start Date  ICMJE June 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00200629 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
Quality of Life measures (assessed by Duke Activity Status Index and Seattle Angina Questionnaire) at 6, 12, 18, and 24 months.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Both Exercise and Adenosine Stress Testing
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Coronary Artery Disease
Intervention  ICMJE
  • Procedure: Adenosine SPECT myocardial perfusion imaging
  • Procedure: Combined adenosine / exercise SPECT myocardial perfusion imaging
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Estimated Enrollment  ICMJE
 (submitted: September 12, 2005)
200
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00200629
Other Study ID Numbers  ICMJE SPEC-BB
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kathleen Franke, Midwest Heart Foundation
Study Sponsor  ICMJE Midwest Heart Foundation
Collaborators  ICMJE
  • GE Healthcare
  • Astellas Pharma US, Inc.
Investigators  ICMJE
Principal Investigator: Robert Hendel, MD Midwest Heart Foundation
PRS Account Midwest Heart Foundation
Verification Date August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP