NCT00774891

Brief Summary

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

October 16, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 17, 2008

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

February 17, 2012

Status Verified

February 1, 2012

Enrollment Period

3.3 years

First QC Date

October 16, 2008

Last Update Submit

February 16, 2012

Conditions

IschemiaAngina

Keywords

Echocardiography- exerciseEchocardiography- dobutamineWall stressVentricular volume-leftIschemiaAnginaHeart diseasesStress echocardiographyVentricular volumeVascular diseases

Outcome Measures

Primary Outcomes (1)

  • Dobutamine stress echocardiography causes decrease in LV size/volume and wall stress compared to exercise stress echocardiography

    1 hour

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Lahey Clinic patients referred by their physician for stress echocardiograms for clinical indications. Approximately 30 patients referred for an exercise stress echocardiography and approximately 30 patients referred for a dobutamine stress echocardiography.

You may qualify if:

  • Age 30-80 years
  • Normal sinus rhythm on electrocardiogram
  • Normal left ventricular systolic function on baseline echocardiogram

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lahey Clinic, Inc.

Burlington, Massachusetts, 01805, United States

Location

Related Publications (12)

  • 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.

    PMID: 8279370BACKGROUND

  • 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.

    PMID: 8459062BACKGROUND

  • 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.

    PMID: 1289098BACKGROUND

  • 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.

    PMID: 9385891BACKGROUND

  • 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.

    PMID: 7797748BACKGROUND

  • 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.

    PMID: 8609338BACKGROUND

  • 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.

    PMID: 7930249BACKGROUND

  • 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.

    PMID: 11916604BACKGROUND

  • 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.

    PMID: 9347270BACKGROUND

  • 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.

    PMID: 18543305BACKGROUND

  • 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.

    PMID: 8697482BACKGROUND

  • 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.

    PMID: 7471358BACKGROUND

MeSH Terms

Conditions

IschemiaAngina PectorisHeart DiseasesVascular Diseases

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsMyocardial IschemiaCardiovascular DiseasesChest PainPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Sherif B. Labib, M.D.

    Lahey Clinic, Inc.

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2008

First Posted

October 17, 2008

Study Start

October 1, 2008

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

February 17, 2012

Record last verified: 2012-02

Locations

US(1)