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IschemiaNCT00774891

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

An observational study of Ischemia and Angina, run by Lahey Clinic at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

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

Who is it for?
Ages 30 to 80 years
Conditions the study is for
Ischemia, Angina
How many people
0 participants
Where
1 siteUnited States
Study dates
Oct 2008to Feb 2012
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Lahey Clinic, Inc.

    Burlington, Massachusetts, 01805

Other trials in United States

About this study

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

Read the detailed 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.

Conditions
Ischemia, Angina
Keywords
Echocardiography- exercise, Echocardiography- dobutamine, Wall stress, Ventricular volume-left, Ischemia, Angina, Heart diseases, Stress echocardiography, Ventricular volume, Vascular diseases
Medical subject headings
Ischemia, Angina Pectoris, Heart Diseases, Vascular Diseases

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 1 hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Oct 2008 (estimated)
  2. Study startOct 2008
  3. Primary completionFeb 2012
  4. Study completionFeb 2012

Why it stopped: difficulty enrolling patients into this study

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00774891
Sponsor's protocol ID
2008-091
Status last verified
Feb 2012
First submitted
16 Oct 2008
Last updated
17 Feb 2012
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 8279370

  • 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.

    PubMed 8459062

  • 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.

    PubMed 1289098

  • 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.

    PubMed 9385891

  • 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.

    PubMed 7797748

  • 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.

    PubMed 8609338

  • 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.

    PubMed 7930249

  • 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.

    PubMed 11916604

  • 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.

    PubMed 9347270

  • 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.

    PubMed 18543305

  • 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.

    PubMed 8697482

  • 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.

    PubMed 7471358

Questions about this trial

What is this clinical trial studying?

An observational study of Ischemia and Angina, run by Lahey Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 17 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dobutamine stress echocardiography causes decrease in LV size/volume and wall stress compared to exercise stress echocardiography (time frame: 1 hour). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00774891, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2012.

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