search
Back to results

Both Exercise and Adenosine Stress Testing

Primary Purpose

Coronary Artery Disease

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Adenosine SPECT myocardial perfusion imaging
Combined adenosine / exercise SPECT myocardial perfusion imaging
Sponsored by
Midwest Heart Foundation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring Women, Diagnostic Testing, Radionuclide Imaging, Stress Testing, Adenosine

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Southwest Heart
  • Sutter Roseville Medical Center
  • Sacramento Heart & Vascular Research Center
  • Delaware SPECT Imaging
  • Jacksonville Heart Center, PA
  • Diagnostic Cardiology, PA
  • Cardiac Disease Specialists
  • Idaho Cardiology Associates
  • Idaho Cardiology Associates
  • North Shore Cardiology
  • Iowa Heart Center
  • Androscoggin Cardiology Associates
  • Cardiovascular Consultants of Maine, PA
  • Albany Associates in Cardiology
  • Mid-Valley Cardiology
  • North Shore University Hospital
  • Cardiology Consultants of Philadelphia
  • Cardiology Consultants of Philadelphia
  • Medical University of SC
  • Deaconess Medical Center

Outcomes

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.

Full Information

First Posted
September 12, 2005
Last Updated
August 8, 2011
Sponsor
Midwest Heart Foundation
Collaborators
GE Healthcare, Astellas Pharma US, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT00200629
Brief Title
Both Exercise and Adenosine Stress Testing
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Terminated
Why Stopped
Poor enrollment
Study Start Date
June 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Midwest Heart Foundation
Collaborators
GE Healthcare, Astellas Pharma US, Inc.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Women, Diagnostic Testing, Radionuclide Imaging, Stress Testing, Adenosine

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Adenosine SPECT myocardial perfusion imaging
Intervention Type
Procedure
Intervention Name(s)
Combined adenosine / exercise SPECT myocardial perfusion imaging
Primary Outcome Measure Information:
Title
Unstable angina requiring hospitalization
Title
non-fatal myocardial infarction
Title
death (cardiac and noncardiac)
Title
stroke
Title
performance of PCI or CABG if more than 1 month after initial evaluation
Title
hospitalization for heart failure after initial treatment is administered.
Secondary Outcome Measure Information:
Title
Quality of Life measures (assessed by Duke Activity Status Index and Seattle Angina Questionnaire) at 6, 12, 18, and 24 months.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Hendel, MD
Organizational Affiliation
Midwest Heart Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southwest Heart
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85715
Country
United States
Facility Name
Sutter Roseville Medical Center
City
Roseville
State/Province
California
ZIP/Postal Code
95661-3037
Country
United States
Facility Name
Sacramento Heart & Vascular Research Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States
Facility Name
Delaware SPECT Imaging
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
Jacksonville Heart Center, PA
City
Jacksonville Beach
State/Province
Florida
ZIP/Postal Code
32250
Country
United States
Facility Name
Diagnostic Cardiology, PA
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Cardiac Disease Specialists
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Idaho Cardiology Associates
City
Boise
State/Province
Idaho
ZIP/Postal Code
83704
Country
United States
Facility Name
Idaho Cardiology Associates
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83704
Country
United States
Facility Name
North Shore Cardiology
City
Bannockburn
State/Province
Illinois
ZIP/Postal Code
60015
Country
United States
Facility Name
Iowa Heart Center
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
Facility Name
Androscoggin Cardiology Associates
City
Auburn
State/Province
Maine
ZIP/Postal Code
04210
Country
United States
Facility Name
Cardiovascular Consultants of Maine, PA
City
Scarborough
State/Province
Maine
ZIP/Postal Code
04074
Country
United States
Facility Name
Albany Associates in Cardiology
City
Albany
State/Province
New York
ZIP/Postal Code
12212
Country
United States
Facility Name
Mid-Valley Cardiology
City
Kingston
State/Province
New York
ZIP/Postal Code
12401
Country
United States
Facility Name
North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Cardiology Consultants of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19146
Country
United States
Facility Name
Cardiology Consultants of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19148
Country
United States
Facility Name
Medical University of SC
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29466
Country
United States
Facility Name
Deaconess Medical Center
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States

12. IPD Sharing Statement

Citations:
Citation
American Heart Association. 2002 Heart and Stroke Statistical Update. Dallas, Texas: American Heart Association; 2002.
Results Reference
background
PubMed Identifier
12569338
Citation
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. doi: 10.1067/mnc.2003.130362. No abstract available. Erratum In: J Nucl Cardiol. 2003 Mar-Apr;10(2):218.
Results Reference
background
PubMed Identifier
8116993
Citation
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. doi: 10.7326/0003-4819-120-7-199404010-00005.
Results Reference
background
PubMed Identifier
10318674
Citation
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. doi: 10.1161/01.cir.99.18.2480. No abstract available.
Results Reference
background
PubMed Identifier
8733082
Citation
Holdright DR, Fox KM. Characterization and identification of women with angina pectoris. Eur Heart J. 1996 Apr;17(4):510-7. doi: 10.1093/oxfordjournals.eurheartj.a014902. No abstract available. Erratum In: Eur Heart J 1996 Sep;17(9):1452.
Results Reference
background
PubMed Identifier
9236456
Citation
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. doi: 10.1161/01.cir.96.1.345. No abstract available.
Results Reference
background
PubMed Identifier
6741986
Citation
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. doi: 10.1016/0002-9343(84)90437-6.
Results Reference
background
PubMed Identifier
10080415
Citation
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. doi: 10.1016/s0002-9149(98)00963-1.
Results Reference
background
PubMed Identifier
9278880
Citation
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. doi: 10.1016/s1071-3581(97)90111-2. No abstract available.
Results Reference
background
PubMed Identifier
9591568
Citation
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.
Results Reference
background
PubMed Identifier
8752792
Citation
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. doi: 10.1016/0735-1097(96)00095-2.
Results Reference
background
PubMed Identifier
9420775
Citation
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. doi: 10.1016/s1071-3581(95)80021-2.
Results Reference
background
PubMed Identifier
11854122
Citation
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. doi: 10.1161/hc0702.103973.
Results Reference
background
PubMed Identifier
11448403
Citation
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. doi: 10.1016/s0002-9149(01)01601-0.
Results Reference
background
PubMed Identifier
12571200
Citation
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.
Results Reference
background
PubMed Identifier
10230746
Citation
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. doi: 10.1016/s0002-9343(98)00388-x.
Results Reference
background
PubMed Identifier
10608582
Citation
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. doi: 10.1016/s1071-3581(99)90091-0.
Results Reference
background
Citation
Shaw LJ, Olson MB, Kelsey SF, et al. Using estimated functional capacity to optimize stress testing for diagnosis and prognosis of coronary artery disease in symptomatic women: Results from the NHLBI-sponsored Women Ischemia Syndrome Evaluation study., in preparation
Results Reference
background
PubMed Identifier
8613606
Citation
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. doi: 10.1016/0735-1097(95)00550-1.
Results Reference
background
PubMed Identifier
9230147
Citation
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. doi: 10.1016/s0002-9149(97)00306-8.
Results Reference
background
PubMed Identifier
7850940
Citation
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. doi: 10.1161/01.cir.91.4.1044.
Results Reference
background
PubMed Identifier
7594033
Citation
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. doi: 10.1016/0735-1097(95)00329-0.
Results Reference
background
PubMed Identifier
9761081
Citation
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. doi: 10.1016/s0002-9149(98)00463-9.
Results Reference
background
PubMed Identifier
11144473
Citation
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. doi: 10.1067/mnc.2000.108737.
Results Reference
background
PubMed Identifier
11986564
Citation
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. doi: 10.1067/mnc.2002.119973.
Results Reference
background
PubMed Identifier
11083192
Citation
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. doi: 10.1067/mnc.2000.108030.
Results Reference
background
PubMed Identifier
12794628
Citation
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. doi: 10.1016/s1071-3581(02)43236-9.
Results Reference
background
PubMed Identifier
10351980
Citation
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. doi: 10.1161/01.cir.99.21.2829. No abstract available.
Results Reference
background
PubMed Identifier
440357
Citation
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. doi: 10.1056/NEJM197906143002402.
Results Reference
background
PubMed Identifier
7249303
Citation
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. doi: 10.1161/01.cir.64.2.360.
Results Reference
background
Citation
Gibbons RJ, Balady GJ, Bricker JT, et al. ACC/AHA 2002 guideline update for exercise testing: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidleines (Committee of Exercise Testing). 2002 American College of Cardiology website. Available at: www.acc.org/clinical/guidleines/exercise/dirIndex.htm
Results Reference
background
PubMed Identifier
11815441
Citation
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. doi: 10.1161/hc0402.102975. No abstract available.
Results Reference
background
Links:
URL
http://www.midwestheart.org
Description
Click here for more information about Midwest Heart Foundation

Learn more about this trial

Both Exercise and Adenosine Stress Testing

We'll reach out to this number within 24 hrs