Both Exercise and Adenosine Stress Testing

NCT00200629 | Terminated Phase 4

• 1 other identifier: SPEC-BB
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 20

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

Conditions

Coronary Artery Disease

Keywords

Women; Diagnostic Testing; Radionuclide Imaging; Stress Testing; Adenosine

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (1)

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

Interventions

Adenosine SPECT myocardial perfusion imaging PROCEDURE

Combined adenosine / exercise SPECT myocardial perfusion imaging PROCEDURE

Eligibility Criteria

• Age: 60 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• ° or 3° atrioventricular block
• Symptomatic heart failure
• Ingestion of theophylline or dipyridamole within the preceding 48 hours
• Unavailability for follow-up

Sponsors & Collaborators

• Midwest Heart Foundation: lead
• GE Healthcare: collaborator
• Astellas Pharma US, Inc.: collaborator

Study Sites (20)

Southwest Heart

Tucson, Arizona, 85715, United States

Location

Sutter Roseville Medical Center

Roseville, California, 95661-3037, United States

Location

Sacramento Heart & Vascular Research Center

Sacramento, California, 95825, United States

Location

Delaware SPECT Imaging

Newark, Delaware, 19713, United States

Location

Diagnostic Cardiology, PA

Jacksonville, Florida, 32216, United States

Location

Jacksonville Heart Center, PA

Jacksonville Beach, Florida, 32250, United States

Location

Cardiac Disease Specialists

Atlanta, Georgia, 30309, United States

Location

Idaho Cardiology Associates

Boise, Idaho, 83704, United States

Location

Idaho Cardiology Associates

Meridian, Idaho, 83704, United States

Location

North Shore Cardiology

Bannockburn, Illinois, 60015, United States

Location

Iowa Heart Center

Des Moines, Iowa, 50314, United States

Location

Androscoggin Cardiology Associates

Auburn, Maine, 04210, United States

Location

Cardiovascular Consultants of Maine, PA

Scarborough, Maine, 04074, United States

Location

Albany Associates in Cardiology

Albany, New York, 12212, United States

Location

Mid-Valley Cardiology

Kingston, New York, 12401, United States

Location

North Shore University Hospital

Manhasset, New York, 11030, United States

Location

Cardiology Consultants of Philadelphia

Philadelphia, Pennsylvania, 19146, United States

Location

Cardiology Consultants of Philadelphia

Philadelphia, Pennsylvania, 19148, United States

Location

Medical University of SC

Charleston, South Carolina, 29466, United States

Location

Deaconess Medical Center

Spokane, Washington, 99204, United States

Location

Related Publications (32)

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

  BACKGROUND

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• 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.

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• 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.

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• 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.

  PMID: 9420775 BACKGROUND

• 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.

  PMID: 11854122 BACKGROUND

• 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.

  PMID: 11448403 BACKGROUND

• 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.

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• 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.

  PMID: 10230746 BACKGROUND

• 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.

  PMID: 10608582 BACKGROUND

• 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

  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.

  PMID: 8613606 BACKGROUND

• 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.

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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

  PMID: 11986564 BACKGROUND

• 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.

  PMID: 11083192 BACKGROUND

• 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.

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Related Links

• Click here for more information about Midwest Heart Foundation

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Robert Hendel, MD

  Midwest Heart Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 20, 2005
• Study Start: June 1, 2005
• Last Updated: August 9, 2011

Record last verified: 2011-08

Locations

US (20)