Both Exercise and Adenosine Stress Testing

This study has been terminated.
(Poor enrollment)
Sponsor:
Collaborators:
GE Healthcare
Astellas Pharma US, Inc.
Information provided by:
Midwest Heart Foundation
ClinicalTrials.gov Identifier:
NCT00200629
First received: September 12, 2005
Last updated: August 8, 2011
Last verified: August 2011
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Midwest Heart Foundation:

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

Estimated Enrollment: 200
Study Start Date: June 2005
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

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00200629

Locations
United States, Arizona
Southwest Heart
Tucson, Arizona, United States, 85715
United States, California
Sutter Roseville Medical Center
Roseville, California, United States, 95661-3037
Sacramento Heart & Vascular Research Center
Sacramento, California, United States, 95825
United States, Delaware
Delaware SPECT Imaging
Newark, Delaware, United States, 19713
United States, Florida
Diagnostic Cardiology, PA
Jacksonville, Florida, United States, 32216
Jacksonville Heart Center, PA
Jacksonville Beach, Florida, United States, 32250
United States, Georgia
Cardiac Disease Specialists
Atlanta, Georgia, United States, 30309
United States, Idaho
Idaho Cardiology Associates
Boise, Idaho, United States, 83704
Idaho Cardiology Associates
Meridian, Idaho, United States, 83704
United States, Illinois
North Shore Cardiology
Bannockburn, Illinois, United States, 60015
United States, Iowa
Iowa Heart Center
Des Moines, Iowa, United States, 50314
United States, Maine
Androscoggin Cardiology Associates
Auburn, Maine, United States, 04210
Cardiovascular Consultants of Maine, PA
Scarborough, Maine, United States, 04074
United States, New York
Albany Associates in Cardiology
Albany, New York, United States, 12212
Mid-Valley Cardiology
Kingston, New York, United States, 12401
North Shore University Hospital
Manhasset, New York, United States, 11030
United States, Pennsylvania
Cardiology Consultants of Philadelphia
Philadelphia, Pennsylvania, United States, 19148
Cardiology Consultants of Philadelphia
Philadelphia, Pennsylvania, United States, 19146
United States, South Carolina
Medical University of SC
Charleston, South Carolina, United States, 29466
United States, Washington
Deaconess Medical Center
Spokane, Washington, United States, 99204
Sponsors and Collaborators
Midwest Heart Foundation
GE Healthcare
Astellas Pharma US, Inc.
Investigators
Principal Investigator: Robert Hendel, MD Midwest Heart Foundation
  More Information

Additional Information:
Publications:
American Heart Association. 2002 Heart and Stroke Statistical Update. Dallas, Texas: American Heart Association; 2002.

Responsible Party: Kathleen Franke, Midwest Heart Foundation
ClinicalTrials.gov Identifier: NCT00200629     History of Changes
Other Study ID Numbers: SPEC-BB
Study First Received: September 12, 2005
Last Updated: August 8, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Midwest Heart Foundation:
Women
Diagnostic Testing
Radionuclide Imaging
Stress Testing
Adenosine

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Adenosine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on September 22, 2014