Both Exercise and Adenosine Stress Testing

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00200629
• Other study ID #: SPEC-BB
• Status: Terminated
• Phase: Phase 4
• First received: September 12, 2005
• Last updated: August 8, 2011
• Start date: June 2005

Study information

• Verified date: August 2011
• Source: Midwest Heart Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 200
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 60 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Procedure:
• Adenosine SPECT myocardial perfusion imaging

• Combined adenosine / exercise SPECT myocardial perfusion imaging

Locations

Country	Name	City	State
United States	Albany Associates in Cardiology	Albany	New York
United States	Cardiac Disease Specialists	Atlanta	Georgia
United States	Androscoggin Cardiology Associates	Auburn	Maine
United States	North Shore Cardiology	Bannockburn	Illinois
United States	Idaho Cardiology Associates	Boise	Idaho
United States	Medical University of SC	Charleston	South Carolina
United States	Iowa Heart Center	Des Moines	Iowa
United States	Diagnostic Cardiology, PA	Jacksonville	Florida
United States	Jacksonville Heart Center, PA	Jacksonville Beach	Florida
United States	Mid-Valley Cardiology	Kingston	New York
United States	North Shore University Hospital	Manhasset	New York
United States	Idaho Cardiology Associates	Meridian	Idaho
United States	Delaware SPECT Imaging	Newark	Delaware
United States	Cardiology Consultants of Philadelphia	Philadelphia	Pennsylvania
United States	Cardiology Consultants of Philadelphia	Philadelphia	Pennsylvania
United States	Sutter Roseville Medical Center	Roseville	California
United States	Sacramento Heart & Vascular Research Center	Sacramento	California
United States	Cardiovascular Consultants of Maine, PA	Scarborough	Maine
United States	Deaconess Medical Center	Spokane	Washington
United States	Southwest Heart	Tucson	Arizona

Sponsors (3)

Lead Sponsor	Collaborator
Midwest Heart Foundation	Astellas Pharma US, Inc., GE Healthcare

Country where clinical trial is conducted

United States, 

References & Publications (32)

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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. — View 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. — View 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. — View 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. — View 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. — View Citation

Holdright DR, Fox KM. Characterization and identification of women with angina pectoris. Eur Heart J. 1996 Apr;17(4):510-7. Review. Erratum in: Eur Heart J 1996 Sep;17(9):1452. — View 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. — View 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. Review. — View Citation

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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. — View 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. Review. Erratum in: J Nucl Cardiol. 2003 Mar-Apr;10(2):218. — View Citation

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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. — View 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. — View Citation

Santana-Boado C, Candell-Riera J, Castell-Conesa J, Aguadé-Bruix S, García-Burillo A, Canela T, González 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. — View 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. — View 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. — View Citation

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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

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. — View Citation

* Note: There are 32 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Unstable angina requiring hospitalization
Primary	non-fatal myocardial infarction
Primary	death (cardiac and noncardiac)
Primary	stroke
Primary	performance of PCI or CABG if more than 1 month after initial evaluation
Primary	hospitalization for heart failure after initial treatment is administered.
Secondary	Quality of Life measures (assessed by Duke Activity Status Index and Seattle Angina Questionnaire) at 6, 12, 18, and 24 months.