Both Exercise and Adenosine Stress Testing

NCT ID: NCT00200629

Last Updated: 2011-08-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-06-30

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Interventions

Adenosine SPECT myocardial perfusion imaging

Intervention Type: PROCEDURE

Combined adenosine / exercise SPECT myocardial perfusion imaging

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

GE Healthcare

INDUSTRY

Sponsor Role: collaborator

Astellas Pharma US, Inc.

INDUSTRY

Sponsor Role: collaborator

Midwest Heart Foundation

OTHER

Sponsor Role: lead

Responsible Party

Midwest Heart Foundation

Principal Investigators

Robert Hendel, MD

Role: PRINCIPAL_INVESTIGATOR

Midwest Heart Foundation

Locations

Southwest Heart

Tucson, Arizona, United States

Sutter Roseville Medical Center

Roseville, California, United States

Sacramento Heart & Vascular Research Center

Sacramento, California, United States

Delaware SPECT Imaging

Newark, Delaware, United States

Diagnostic Cardiology, PA

Jacksonville, Florida, United States

Jacksonville Heart Center, PA

Jacksonville Beach, Florida, United States

Cardiac Disease Specialists

Atlanta, Georgia, United States

Idaho Cardiology Associates

Boise, Idaho, United States

Idaho Cardiology Associates

Meridian, Idaho, United States

North Shore Cardiology

Bannockburn, Illinois, United States

Iowa Heart Center

Des Moines, Iowa, United States

Androscoggin Cardiology Associates

Auburn, Maine, United States

Cardiovascular Consultants of Maine, PA

Scarborough, Maine, United States

Albany Associates in Cardiology

Albany, New York, United States

Mid-Valley Cardiology

Kingston, New York, United States

North Shore University Hospital

Manhasset, New York, United States

Cardiology Consultants of Philadelphia

Philadelphia, Pennsylvania, United States

Cardiology Consultants of Philadelphia

Philadelphia, Pennsylvania, United States

Medical University of SC

Charleston, South Carolina, United States

Deaconess Medical Center

Spokane, Washington, United States

Countries

United States

References

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

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 12569338 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 8116993 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10318674 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 8733082 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9236456 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 6741986 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10080415 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9278880 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9591568 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 8752792 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9420775 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11854122 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11448403 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12571200 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10230746 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10608582 (View on PubMed)

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

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 8613606 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9230147 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 7850940 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 7594033 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9761081 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11144473 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11986564 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11083192 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12794628 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10351980 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 440357 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 7249303 (View on PubMed)

Gibbons RJ, Balady GJ, Bricker JT, Chaitman BR, Fletcher GF, Froelicher VF, Mark DB, McCallister BD, Mooss AN, O'Reilly MG, Winters WL, Gibbons RJ, Antman EM, Alpert JS, Faxon DP, Fuster V, Gregoratos G, Hiratzka LF, Jacobs AK, Russell RO, Smith SC; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Committee to Update the 1997 Exercise Testing Guidelines. ACC/AHA 2002 guideline update for exercise testing: summary article. A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Update the 1997 Exercise Testing Guidelines). J Am Coll Cardiol. 2002 Oct 16;40(8):1531-40. doi: 10.1016/s0735-1097(02)02164-2. No abstract available.

Reference Type: BACKGROUND

PMID: 12392846 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11815441 (View on PubMed)

Related Links

http://www.midwestheart.org

Click here for more information about Midwest Heart Foundation

Other Identifiers

SPEC-BB

Identifier Type: -

Identifier Source: org_study_id