Comparison Of Left Ventricular Volume And Wall Stress With Dobutamine And Exercise Echocardiography

NCT ID: NCT00774891

Last Updated: 2012-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2008-10-31

Study Completion Date

2012-02-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ischemia Angina

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Lahey Clinic

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sherif B. Labib, M.D.

Role: PRINCIPAL_INVESTIGATOR

Lahey Clinic, Inc.

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Lahey Clinic, Inc.

Burlington, Massachusetts, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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. doi: 10.1016/0002-9149(94)90719-6.

Reference Type BACKGROUND
PMID: 8279370 (View on PubMed)

Mertes H, Erbel R, Nixdorff U, Mohr-Kahaly S, Kruger 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. doi: 10.1016/0735-1097(93)90229-t.

Reference Type BACKGROUND
PMID: 8459062 (View on PubMed)

Perez JE, Waggoner AD, Davila-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. doi: 10.1093/oxfordjournals.eurheartj.a060123.

Reference Type BACKGROUND
PMID: 1289098 (View on PubMed)

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. doi: 10.1016/s0735-1097(97)00376-8.

Reference Type BACKGROUND
PMID: 9385891 (View on PubMed)

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. doi: 10.1016/0735-1097(95)00121-f.

Reference Type BACKGROUND
PMID: 7797748 (View on PubMed)

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. doi: 10.1016/0735-1097(95)00583-8.

Reference Type BACKGROUND
PMID: 8609338 (View on PubMed)

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. doi: 10.1016/0735-1097(94)90108-2.

Reference Type BACKGROUND
PMID: 7930249 (View on PubMed)

Joseph T, Vieillard-Baron A, Chikli F, Goeau-Brissoniere 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. doi: 10.1053/euje.2000.0039.

Reference Type BACKGROUND
PMID: 11916604 (View on PubMed)

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. doi: 10.1093/oxfordjournals.eurheartj.a015139.

Reference Type BACKGROUND
PMID: 9347270 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18543305 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8697482 (View on PubMed)

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. doi: 10.1161/01.cir.63.5.1008. No abstract available.

Reference Type BACKGROUND
PMID: 7471358 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2008-091

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Cardiovascular Disease Screening
NCT00483951 TERMINATED