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Both Exercise and Adenosine Stress Testing
This study is currently recruiting participants.
Verified by Midwest Heart Foundation, February 2006
Sponsors and Collaborators: Midwest Heart Foundation
GE Healthcare
Astellas Pharma US, Inc.
Information provided by: Midwest Heart Foundation
ClinicalTrials.gov Identifier: NCT00200629
  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 IV

MedlinePlus related topics: Coronary Artery Disease Exercise and Physical Fitness
Drug Information available for: Adenosine
U.S. FDA Resources
Study Type: Interventional
Study Design: Diagnostic, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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

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

Contacts
Contact: Kathleen Korrigan, RN, CCRC 617-423-7999 ext 124 kcorrigan@ccstrials.com
Contact: Patricia M Wedge, RN, CCRC 617-423-7999 ext 118 pwedge@ccstrials.com

Locations
United States, Arizona
Southwest Heart Recruiting
Tucson, Arizona, United States, 85715
Contact: Ken Peart            
Principal Investigator: Brenda Peart            
United States, California
Sacramento Heart & Vascular Research Center Recruiting
Sacramento, California, United States, 95825
Contact: Deborah Homes     916-830-2044 ext 7        
Principal Investigator: Raye Bellinger            
Sutter Roseville Medical Center Recruiting
Roseville, California, United States, 95661-3037
Contact: Michelle Rouquet     916-781-1474        
Principal Investigator: Frederick Weiland            
United States, Delaware
Delaware SPECT Imaging Recruiting
Newark, Delaware, United States, 19713
Contact: Colleen Buchanan     610-268-0597        
Principal Investigator: Steven Edell            
United States, Florida
Jacksonville Heart Center, PA Recruiting
Jacksonville Beach, Florida, United States, 32250
Contact: Jill DePauw     904-339-0037        
Principal Investigator: Pamela Ramos Rama            
Diagnostic Cardiology, PA Recruiting
Jacksonville, Florida, United States, 32216
Contact: Melody Thompson     904-296-0278        
Principal Investigator: William Short            
United States, Georgia
Cardiac Disease Specialists Recruiting
Atlanta, Georgia, United States, 30309
Contact: Stephanie Cadsawan     404-355-9815 ext 235        
Principal Investigator: Sally Beer, MD            
United States, Idaho
Idaho Cardiology Associates Recruiting
Meridian, Idaho, United States, 83704
Contact: Kathy Curry     208-685-2213        
Principal Investigator: Andrew Chai            
Idaho Cardiology Associates Recruiting
Boise, Idaho, United States, 83704
Contact: Kathy Curry     208-685-2213        
Principal Investigator: David Hinchman            
United States, Illinois
North Shore Cardiology Recruiting
Bannockburn, Illinois, United States, 60015
Contact: Lynn Steckel     847-444-5340        
Contact: Eleonora Mitova     847-444-5340        
Principal Investigator: Jay Alexander, MD            
United States, Iowa
Iowa Heart Center Recruiting
Des Moines, Iowa, United States, 50314
Contact: Deb French     515-633-3844        
Principal Investigator: Margaret Verhey            
United States, Maine
Cardiovascular Consultants of Maine, PA Recruiting
Scarborough, Maine, United States, 04074
Contact: Brenda Glasgow     207-782-9835 ext 3608        
Principal Investigator: Craig Brett            
Androscoggin Cardiology Associates Recruiting
Auburn, Maine, United States, 04210
Contact: Michelle Bergeron            
Principal Investigator: Dervilla McCann            
United States, New York
Mid-Valley Cardiology Recruiting
Kingston, New York, United States, 12401
Contact: Martha Meyer     845-331-6600 ext 107        
Principal Investigator: Ellis Lader            
North Shore University Hospital Recruiting
Manhasset, New York, United States, 11030
Contact: Diane Redmond     516-562-2653        
Principal Investigator: Jennifer Mieres            
Albany Associates in Cardiology Recruiting
Albany, New York, United States, 12212
Contact: Sandra Preston     518-435-2759        
Principal Investigator: David Wolinsky            
United States, Pennsylvania
Cardiology Consultants of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19148
Contact: Trish McNeilis     215-339-0541        
Principal Investigator: Veronica Covalesky            
Cardiology Consultants of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19146
Contact: Trish McNeilis     215-893-8021        
Principal Investigator: Santosh Gupta-Bala            
United States, South Carolina
Medical University of SC Recruiting
Charleston, South Carolina, United States, 29466
Contact: Michelle Burke     843-792-1957        
Principal Investigator: Leonie Gordon            
United States, Washington
Deaconess Medical Center Recruiting
Spokane, Washington, United States, 99204
Contact: Monica Pounder     509-473-3480        
Principal Investigator: Janice Christensen            
Sponsors and Collaborators
Midwest Heart Foundation
GE Healthcare
Astellas Pharma US, Inc.
Investigators
Principal Investigator: Robert Hendel, MD Midwest Heart Foundation
  More Information

Click here for more information about Midwest Heart Foundation  This link exits the ClinicalTrials.gov site

Publications:
American Heart Association. 2002 Heart and Stroke Statistical Update. Dallas, Texas: American Heart Association; 2002.
Mieres JH, Shaw LJ, Hendel RC, Miller DD, Bonow RO, Berman DS, Heller GV, Mieres JH, Bairey-Merz CN, Berman DS, Bonow RO, Cacciabaudo JM, Heller GV, Hendel RC, Kiess MC, Miller DD, Polk DM, Shaw LJ, Smanio PE, Walsh MN; Writing Group on Perfusion Imaging in Women. American Society of Nuclear Cardiology consensus statement: Task Force on Women and Coronary Artery Disease--the role of myocardial perfusion imaging in the clinical evaluation of coronary artery disease in women [correction]. J Nucl Cardiol. 2003 Jan-Feb;10(1):95-101. Review. No abstract available. Erratum in: J Nucl Cardiol. 2003 Mar-Apr;10(2):218.
Shaw LJ, Miller DD, Romeis JC, Kargl D, Younis LT, Chaitman BR. Gender differences in the noninvasive evaluation and management of patients with suspected coronary artery disease. Ann Intern Med. 1994 Apr 1;120(7):559-66.
Mosca L, Grundy SM, Judelson D, King K, Limacher M, Oparil S, Pasternak R, Pearson TA, Redberg RF, Smith SC Jr, Winston M, Zinberg S. Guide to Preventive Cardiology for Women.AHA/ACC Scientific Statement Consensus panel statement. Circulation. 1999 May 11;99(18):2480-4. Review. No abstract available.
Holdright DR, Fox KM. Characterization and identification of women with angina pectoris. Eur Heart J. 1996 Apr;17(4):510-7. Review. No abstract available. Erratum in: Eur Heart J 1996 Sep;17(9):1452.
Gibbons RJ, Balady GJ, Beasley JW, Bricker JT, Duvernoy WF, Froelicher VF, Mark DB, Marwick TH, McCallister BD, Thompson PD, Winters WL Jr, Yanowitz FG, Ritchie JL, Cheitlin MD, Eagle KA, Gardner TJ, Garson A Jr, Lewis RP, O'Rourke RA, Ryan TJ. ACC/AHA guidelines for exercise testing: executive summary. A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee on Exercise Testing). Circulation. 1997 Jul 1;96(1):345-54. No abstract available.
Hlatky MA, Pryor DB, Harrell FE Jr, Califf RM, Mark DB, Rosati RA. Factors affecting sensitivity and specificity of exercise electrocardiography. Multivariable analysis. Am J Med. 1984 Jul;77(1):64-71.
Kwok Y, Kim C, Grady D, Segal M, Redberg R. Meta-analysis of exercise testing to detect coronary artery disease in women. Am J Cardiol. 1999 Mar 1;83(5):660-6.
Iskandrian AE, Heo J, Nallamothu N. Detection of coronary artery disease in women with use of stress single-photon emission computed tomography myocardial perfusion imaging. J Nucl Cardiol. 1997 Jul-Aug;4(4):329-35. Review. No abstract available.
Santana-Boado C, Candell-Riera J, Castell-Conesa J, Aguade-Bruix S, Garcia-Burillo A, Canela T, Gonzalez JM, Cortadellas J, Ortega D, Soler-Soler J. Diagnostic accuracy of technetium-99m-MIBI myocardial SPECT in women and men. J Nucl Med. 1998 May;39(5):751-5.
Hachamovitch R, Berman DS, Kiat H, Bairey CN, Cohen I, Cabico A, Friedman J, Germano G, Van Train KF, Diamond GA. Effective risk stratification using exercise myocardial perfusion SPECT in women: gender-related differences in prognostic nuclear testing. J Am Coll Cardiol. 1996 Jul;28(1):34-44.
Pancholy SB, Fattah AA, Kamal AM, Ghods M, Heo J, Iskandrian AS. Independent and incremental prognostic value of exercise thallium single-photon emission computed tomographic imaging in women. J Nucl Cardiol. 1995 Mar-Apr;2(2 Pt 1):110-6.
Hachamovitch R, Berman DS, Kiat H, Cohen I, Friedman JD, Shaw LJ. Value of stress myocardial perfusion single photon emission computed tomography in patients with normal resting electrocardiograms: an evaluation of incremental prognostic value and cost-effectiveness. Circulation. 2002 Feb 19;105(7):823-9.
Galassi AR, Azzarelli S, Tomaselli A, Giosofatto R, Ragusa A, Musumeci S, Tamburino C, Giuffrida G. Incremental prognostic value of technetium-99m-tetrofosmin exercise myocardial perfusion imaging for predicting outcomes in patients with suspected or known coronary artery disease. Am J Cardiol. 2001 Jul 15;88(2):101-6.
Shaw LJ, Hendel R, Borges-Neto S, Lauer MS, Alazraki N, Burnette J, Krawczynska E, Cerqueira M, Maddahi J; Myoview Multicenter Registry. Prognostic value of normal exercise and adenosine (99m)Tc-tetrofosmin SPECT imaging: results from the multicenter registry of 4,728 patients. J Nucl Med. 2003 Feb;44(2):134-9. Erratum in: J Nucl Med. 2003 Apr;44(4):648.
Marwick TH, Shaw LJ, Lauer MS, Kesler K, Hachamovitch R, Heller GV, Travin MI, Borges-Neto S, Berman DS, Miller DD. The noninvasive prediction of cardiac mortality in men and women with known or suspected coronary artery disease. Economics of Noninvasive Diagnosis (END) Study Group. Am J Med. 1999 Feb;106(2):172-8.
Shaw LJ, Heller GV, Travin MI, Lauer M, Marwick T, Hachamovitch R, Berman DS, Miller DD. Cost analysis of diagnostic testing for coronary artery disease in women with stable chest pain. Economics of Noninvasive Diagnosis (END) Study Group. J Nucl Cardiol. 1999 Nov-Dec;6(6):559-69.
Amanullah AM, Kiat H, Friedman JD, Berman DS. Adenosine technetium-99m sestamibi myocardial perfusion SPECT in women: diagnostic efficacy in detection of coronary artery disease. J Am Coll Cardiol. 1996 Mar 15;27(4):803-9.
Amanullah AM, Berman DS, Hachamovitch R, Kiat H, Kang X, Friedman JD. Identification of severe or extensive coronary artery disease in women by adenosine technetium-99m sestamibi SPECT. Am J Cardiol. 1997 Jul 15;80(2):132-7.
Hendel RC, Chen MH, L'Italien GJ, Newell JB, Paul SD, Eagle KA, Leppo JA. Sex differences in perioperative and long-term cardiac event-free survival in vascular surgery patients. An analysis of clinical and scintigraphic variables. Circulation. 1995 Feb 15;91(4):1044-51.
Heller GV, Herman SD, Travin MI, Baron JI, Santos-Ocampo C, McClellan JR. Independent prognostic value of intravenous dipyridamole with technetium-99m sestamibi tomographic imaging in predicting cardiac events and cardiac-related hospital admissions. J Am Coll Cardiol. 1995 Nov 1;26(5):1202-8.
Amanullah AM, Berman DS, Erel J, Kiat H, Cohen I, Germano G, Friedman JD, Hachamovitch R. Incremental prognostic value of adenosine myocardial perfusion single-photon emission computed tomography in women with suspected coronary artery disease. Am J Cardiol. 1998 Sep 15;82(6):725-30.
Elliott MD, Holly TA, Leonard SM, Hendel RC. Impact of an abbreviated adenosine protocol incorporating adjunctive treadmill exercise on adverse effects and image quality in patients undergoing stress myocardial perfusion imaging. J Nucl Cardiol. 2000 Nov-Dec;7(6):584-9.
Samady H, Wackers FJ, Joska TM, Zaret BL, Jain D. Pharmacologic stress perfusion imaging with adenosine: role of simultaneous low-level treadmill exercise. J Nucl Cardiol. 2002 Mar-Apr;9(2):188-96.
Thomas GS, Prill NV, Majmundar H, Fabrizi RR, Thomas JJ, Hayashida C, Kothapalli S, Payne JL, Payne MM, Miyamoto MI. Treadmill exercise during adenosine infusion is safe, results in fewer adverse reactions, and improves myocardial perfusion image quality. J Nucl Cardiol. 2000 Sep-Oct;7(5):439-46.
Holly TA, Satran A, Bromet DS, Mieres JH, Frey MJ, Elliott MD, Heller GV, Hendel RC. The impact of adjunctive adenosine infusion during exercise myocardial perfusion imaging: Results of the Both Exercise and Adenosine Stress Test (BEAST) trial. J Nucl Cardiol. 2003 May-Jun;10(3):291-6.
Gibbons RJ, Chatterjee K, Daley J, Douglas JS, Fihn SD, Gardin JM, Grunwald MA, Levy D, Lytle BW, O'Rourke RA, Schafer WP, Williams SV. ACC/AHA/ACP-ASIM guidelines for the management of patients with chronic stable angina: executive summary and recommendations. A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee on Management of Patients with Chronic Stable Angina). Circulation. 1999 Jun 1;99(21):2829-48. No abstract available.
Diamond GA, Forrester JS. Analysis of probability as an aid in the clinical diagnosis of coronary-artery disease. N Engl J Med. 1979 Jun 14;300(24):1350-8.
Chaitman BR, Bourassa MG, Davis K, Rogers WJ, Tyras DH, Berger R, Kennedy JW, Fisher L, Judkins MP, Mock MB, Killip T. Angiographic prevalence of high-risk coronary artery disease in patient subsets (CASS). Circulation. 1981 Aug;64(2):360-7.
Cerqueira MD, Weissman NJ, Dilsizian V, Jacobs AK, Kaul S, Laskey WK, Pennell DJ, Rumberger JA, Ryan T, Verani MS; American Heart Association Writing Group on Myocardial Segmentation and Registration for Cardiac Imaging. Standardized myocardial segmentation and nomenclature for tomographic imaging of the heart: a statement for healthcare professionals from the Cardiac Imaging Committee of the Council on Clinical Cardiology of the American Heart Association. Circulation. 2002 Jan 29;105(4):539-42. Review. No abstract available.

Study ID Numbers: SPEC-BB
Study First Received: September 12, 2005
Last Updated: February 16, 2006
ClinicalTrials.gov Identifier: NCT00200629  
Health Authority: United States: Food and Drug Administration

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

Study placed in the following topic categories:
Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Stress
Arteriosclerosis
Ischemia
Adenosine
Coronary Artery Disease

Additional relevant MeSH terms:
Vasodilator Agents
Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Cardiovascular Diseases
Cardiovascular Agents
Anti-Arrhythmia Agents
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009