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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00774891
Other study ID # 2008-091
Secondary ID
Status Withdrawn
Phase N/A
First received October 16, 2008
Last updated February 16, 2012
Start date October 2008
Est. completion date February 2012

Study information

Verified date February 2012
Source Lahey Clinic
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

This study will compare the physiologic responses between exercise stress echocardiography and pharmacologic stress echocardiography on left ventricular volume and wall stress.


Description:

This prospective observational study will compare the physiologic responses between exercise stress echocardiography and dobutamine stress echocardiography on left ventricular volume and wall stress. Exercise and dobutamine stress testing are two widely employed diagnostic modalities that are often used, interchangeably, to detect inducible ischemia. We hypothesize that dobutamine leads to significantly lower ventricular volumes and wall stress than exercise.

Some previous studies have shown that dobutamine and exercise echocardiography have comparable sensitivities and specificities, differences exist between the hemodynamic effects produced by each modality on the cardiovascular system. These variable effects may lead to differences in left ventricular size, volume and wall stress. If divergent left ventricular effects exist(between exercise and dobutamine induced stress), then the degree of myocardial oxygen consumption, ischemic burden, and ischemic threshold observed during exercise and dobutamine stress testing may be different between these commonly used modalities of stress testing.

The potentially variable effects on the left ventricle in response to the modality used to induce stress would highlight a physiological difference between exercise and dobutamine stress testing. Differences in volumes and stress could also help explain the greater of ischemia and higher frequency of angina and ST-segment deviation which has been previously observed in some studies during exercise as compared to dobutamine echocardiography. The presence or lack of these expected hemodynamic responses may also have additional diagnostic and prognostic implications.

The study involves the collection of data among patients undergoing stress echocardiograms that are clinically indicated. This data will be retrieved from the echocardiogram and report and medical chart, including baseline clinical characteristics, exercise parameters achieved during the test.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date February 2012
Est. primary completion date February 2012
Accepts healthy volunteers No
Gender Both
Age group 30 Years to 80 Years
Eligibility Inclusion Criteria:

- Age 30-80 years

- Normal sinus rhythm on electrocardiogram

- Normal left ventricular systolic function on baseline echocardiogram

Exclusion Criteria:

- Patients with stress-induced wall motion abnormalities

- Left ventricular hypertrophy

- Evidence of prior myocardial infarction

- More than mild valvular heart disease

- Prior cardiac surgery

- Poor technical quality of echocardiogram

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
United States Lahey Clinic, Inc. Burlington Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Lahey Clinic

Country where clinical trial is conducted

United States, 

References & Publications (12)

Attenhofer CH, Pellikka PA, Oh JK, Roger VL, Sohn DW, Seward JB. Comparison of ischemic response during exercise and dobutamine echocardiography in patients with left main coronary artery disease. J Am Coll Cardiol. 1996 Apr;27(5):1171-7. — View Citation

Coletta C, Galati A, Ricci R, Sestili A, Guagnozzi G, Re F, Ceci V. Prognostic value of left ventricular volume response during dobutamine stress echocardiography. Eur Heart J. 1997 Oct;18(10):1599-605. — View Citation

Dagianti A, Penco M, Agati L, Sciomer S, Dagianti A, Rosanio S, Fedele F. Stress echocardiography: comparison of exercise, dipyridamole and dobutamine in detecting and predicting the extent of coronary artery disease. J Am Coll Cardiol. 1995 Jul;26(1):18-25. Erratum in: J Am Coll Cardiol 1995 Oct;26(4):1114. — View Citation

Dagianti A, Rosanio S, Tocchi M, Trambaiolo P, Vitarelli A, Fedele F. [Left ventricular volumetric and contractility behavior during stress echocardiography with dobutamine]. Cardiologia. 1996 Mar;41(3):251-8. Italian. — View Citation

Dehmer GJ, Lewis SE, Hillis LD, Corbett J, Parkey RW, Willerson JT. Exercise-induced alterations in left ventricular volumes and the pressure-volume relationship: a sensitive indicator of left ventricular dysfunction in patients with coronary artery disease. Circulation. 1981 May;63(5):1008-18. — View Citation

Iwasaka T, Nakamura S, Sugiura T, Tarumi N, Yuasa F, Morita Y, Wakayama Y, Inada M. Difference between women and men in left ventricular pump function during predischarge exercise test after acute myocardial infarction. Am J Cardiol. 1994 Jan 1;73(1):11-5. — View Citation

Joseph T, Vieillard-Baron A, Chikli F, Goeau-Brissonière O, Coggia M, Lacombe P, Dubourg O. Left ventricular volume analysis for the detection of coronary artery disease during dobutamine stress echocardiography in patients undergoing vascular surgery. Eur J Echocardiogr. 2000 Dec;1(4):263-70. — View Citation

Mertes H, Erbel R, Nixdorff U, Mohr-Kahaly S, Krüger S, Meyer J. Exercise echocardiography for the evaluation of patients after nonsurgical coronary artery revascularization. J Am Coll Cardiol. 1993 Apr;21(5):1087-93. — View Citation

Olson CE, Porter TR, Deligonul U, Xie F, Anderson JR. Left ventricular volume changes during dobutamine stress echocardiography identify patients with more extensive coronary artery disease. J Am Coll Cardiol. 1994 Nov 1;24(5):1268-73. — View Citation

Pérez JE, Waggoner AD, Dávila-Roman VG, Cardona H, Miller JG. On-line quantification of ventricular function during dobutamine stress echocardiography. Eur Heart J. 1992 Dec;13(12):1669-76. — View Citation

Rallidis L, Cokkinos P, Tousoulis D, Nihoyannopoulos P. Comparison of dobutamine and treadmill exercise echocardiography in inducing ischemia in patients with coronary artery disease. J Am Coll Cardiol. 1997 Dec;30(7):1660-8. — View Citation

Rim SJ, Ha JW, Lee MH, Jang Y, Chung N. Left ventricular remodeling can be predicted with left ventricular volume response during dobutamine echocardiography after acute myocardial infarction. Clin Cardiol. 2008 Jun;31(6):259-64. doi: 10.1002/clc.20207. — View Citation

* Note: There are 12 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Dobutamine stress echocardiography causes decrease in LV size/volume and wall stress compared to exercise stress echocardiography 1 hour No
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